1
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Darling JD, Caron E, van Galen I, Park J, Guetter C, Liang P, Lee A, Stangenberg L, Wyers MC, Hamdan AD, Schermerhorn ML. Outcomes Following Drug-coated Balloons and Drug-eluting Stents in Patients with Peripheral Arterial Disease. J Vasc Surg 2025:S0741-5214(25)00908-5. [PMID: 40204033 DOI: 10.1016/j.jvs.2025.02.050] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/31/2024] [Revised: 02/03/2025] [Accepted: 02/08/2025] [Indexed: 04/11/2025]
Abstract
BACKGROUND Drug-coated balloons and drug-eluting stents (DCB/DES) have shown promise in improving outcomes for patients with peripheral artery disease (PAD), however, more real-world analyses are needed to better understand the role of this technology within current practice. As such, we compared our institution's experience with DCB/DES versus percutaneous transluminal angioplasty with or without stenting (PTA/S) for the treatment of PAD. METHODS All patients undergoing an infra-inguinal endovascular intervention for PAD at our institution between 2016 to 2022 were retrospectively reviewed. Patients undergoing isolated supra-inguinal or tibial interventions were excluded. Outcomes included primary patency, freedom from major adverse limb events (MALE), limb salvage, and amputation-free survival (AFS). To account for baseline differences, one-to-one propensity score matching was performed between DCB/DES and PTA/S groups. Outcomes were further evaluated using chi-squared, Kaplan-Meier analyses, and Cox regression analyses. RESULTS Between 2016 and 2022, 800 patients underwent an endovascular infra-inguinal intervention for PAD: 224 DCB/DES and 576 PTA/S. Prior to matching, DCB/DES patients were younger (69 vs. 72 years), more often male (72% vs. 65%), nonwhite (58%, vs. 34%), had a history of smoking (77% vs. 64%), were more likely to have had a prior ipsilateral intervention (45% vs. 10%), and more often presented with claudication (44% vs. 18%) (all p<.05). After matching, 211 patients were included in each group, where the only remaining difference between DCB/DES and PTA/S was prior ipsilateral intervention (40% vs. 15%, p<.001). Following DCB/DES, Kaplan-Meier analyses demonstrated higher rates of primary patency (65% vs. 54%; p<.01) and higher freedom from MALE (three-year rates: 84% vs 75%; p=.04), correlating with a 38% lower event risk in both outcomes (HR 0.62, 95% CI [0.44-0.89] and HR 0.62 [0.39-0.99], respectively). No differences were noted in rates of limb salvage (three-year rates: 94% vs. 90%, p=.63) or AFS (three-year rates: 78% vs. 71%; p=.13). When stratifying by indication, DCB/DES demonstrated higher rates of freedom from MALE among patients with CLTI (three-year rates: 85% vs. 66%; p=.02). CONCLUSIONS Among a matched cohort of patients with PAD undergoing endovascular intervention, DCB/DES, as compared to PTA/S, demonstrated higher rates of primary patency and freedom from MALE, the former treatment effect remaining notable among patients with claudication and the latter among patients with CLTI. These data demonstrate the importance of further analyses on this evolving technology.
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Affiliation(s)
- Jeremy D Darling
- Department of Surgery, Division of Vascular and Endovascular Surgery, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA
| | - Elisa Caron
- Department of Surgery, Division of Vascular and Endovascular Surgery, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA
| | - Isa van Galen
- Department of Surgery, Division of Vascular and Endovascular Surgery, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA
| | - Jemin Park
- Department of Surgery, Division of Vascular and Endovascular Surgery, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA
| | - Camila Guetter
- Department of Surgery, Division of Vascular and Endovascular Surgery, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA
| | - Patric Liang
- Department of Surgery, Division of Vascular and Endovascular Surgery, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA
| | - Andy Lee
- Department of Surgery, Division of Vascular and Endovascular Surgery, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA
| | - Lars Stangenberg
- Department of Surgery, Division of Vascular and Endovascular Surgery, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA
| | - Mark C Wyers
- Department of Surgery, Division of Vascular and Endovascular Surgery, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA
| | - Allen D Hamdan
- Department of Surgery, Division of Vascular and Endovascular Surgery, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA
| | - Marc L Schermerhorn
- Department of Surgery, Division of Vascular and Endovascular Surgery, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA.
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2
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Abstract
PURPOSE Peripheral arterial disease (PAD) is characterized by atherosclerotic arterial occlusive disease of the lower extremities and is associated with an increased risk of major adverse cardiovascular events (MACE) in addition to disabling clinical sequelae, including intermittent claudication and chronic limb-threatening ischemia (CLTI). Given the growing burden of disease, knowledge of modern practices to prevent MACE and major adverse limb events (MALE) is essential. This review article examines evidence for medical management of PAD and its associated risk factors, as well as wound prevention and care. METHODS A thorough review of the literature was performed, with attention to evidence for the management of modifiable atherosclerotic risk factors, claudication symptoms, wound prevention, and wound care. RESULTS Contemporary management of PAD requires a multi-faceted approach to care, with medical optimization of smoking, hypertension, hyperlipidemia, and diabetes mellitus. The use of supervised exercise therapy for intermittent claudication is highlighted. The anatomic disease patterns of smoking and diabetes mellitus are discussed further, and best practices for diabetic foot ulcer prevention, including offloading footwear, are described. Quality wound care is essential in this patient population and involves strategic use of debridement, wound-healing adjuncts, and skin substitutes, when appropriate. CONCLUSION The objective of medical management of PAD is to reduce the risk of MACE and MALE. Atherosclerotic risk factor optimization, appropriate wound care, and management of diabetic foot ulcers, foot infections, gangrene, and chronic, non-healing wounds are critical components of PAD care. Interdisciplinary care is essential to coordinate care, leverage expertise, and improve outcomes.
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Affiliation(s)
- Ian O Cook
- Division of Vascular Surgery and Endovascular Therapy, Michael E. DeBakey Department of Surgery, Baylor College of Medicine, One Baylor Plaza, BCM 390, Houston, TX, 77030, USA
| | - Jayer Chung
- Division of Vascular Surgery and Endovascular Therapy, Michael E. DeBakey Department of Surgery, Baylor College of Medicine, One Baylor Plaza, BCM 390, Houston, TX, 77030, USA.
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3
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Braga D, Dobson L, Rahnemai-Azar AA, Sauk S, Guevara CJ, Ushinsky A. A Laser Atherectomy-Thrombectomy System for Primary Management of Acute Limb Ischemia. J Vasc Interv Radiol 2025; 36:635-640. [PMID: 39667620 DOI: 10.1016/j.jvir.2024.12.003] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/11/2024] [Revised: 11/24/2024] [Accepted: 12/02/2024] [Indexed: 12/14/2024] Open
Abstract
PURPOSE To evaluate the primary use of a laser atherectomy-thrombectomy system in patients with acute limb ischemia (ALI). MATERIALS AND METHODS A single-center retrospective review of patients presenting with ALI (≤14 days) from August 2021 to February 2024 treated primarily with a laser atherectomy-thrombectomy system (Auryon; AngioDynamics, Queensbury, New York) was performed. Technical success was defined by resolution of the acute occlusion with adequate inflow and outflow with pedal signals detectable by handheld Doppler ultrasound (US). The primary clinical endpoints were resolution of symptoms without readmission or reintervention in the immediate postprocedural period and at 30 days with follow-up duplex US documenting patency of the treated limb. Twenty-four procedures in 21 patients were included (mean age, 60 years; males:females, 12:9). Seventy-five percent (18/24) of patients presented with Rutherford 1, 12.5% (3/24) presented with Rutherford 2A, and 12.5% (3/24) presented with Rutherford 2B, with a mean symptom duration of 4 days. RESULTS Technical success was 92% (22/24) in a single session. Two technical failures required overnight adjuvant thrombolysis. All patients met the immediate postprocedural endpoint, and 92% met the 30-day endpoint. There were no major device-related adverse events or deaths within 30 days, with a major amputation rate of 5%. Distal embolization occurred in 7 (29%) of cases, most of which were focal tibial emboli occurring after adjunctive plain balloon clot maceration and resolved with balloon maceration and/or additional passes of the laser atherectomy-thrombectomy system. CONCLUSIONS The use of a laser atherectomy-thrombectomy system is a feasible option as a primary treatment modality for ALI.
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Affiliation(s)
- Daniel Braga
- Department of Interventional Radiology, Mallinckrodt Institute of Radiology, St. Louis, Missouri.
| | - Lucas Dobson
- Department of Interventional Radiology, Mallinckrodt Institute of Radiology, St. Louis, Missouri
| | - Amir Ata Rahnemai-Azar
- Department of Interventional Radiology, Mallinckrodt Institute of Radiology, St. Louis, Missouri
| | - Steven Sauk
- Department of Interventional Radiology, Mallinckrodt Institute of Radiology, St. Louis, Missouri
| | - Carlos J Guevara
- Department of Interventional Radiology, Mallinckrodt Institute of Radiology, St. Louis, Missouri
| | - Alexander Ushinsky
- Department of Interventional Radiology, Mallinckrodt Institute of Radiology, St. Louis, Missouri
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4
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Buso G, Hersant J, Keller S, Kalaja I, Bigolin P, Porceddu E, Ghirardini F, Novaković M, Meilak DG, Džupina A, Gary T, Bura-Rivière A, Heiss C, Lanzi S, Madaric J, Boc V, Sprynger M, Mirault T, Brodmann M, Schlager O, Mazzolai L. Cutting-edge European guidelines for managing lower extremity peripheral arterial disease - Featuring selected insights on PAD management. VASA 2025. [PMID: 40084845 DOI: 10.1024/0301-1526/a001186] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 03/16/2025]
Abstract
The new guidelines for the management of peripheral arterial and aortic diseases (PAAD) from the European Society of Cardiology and endorsed by the European Society of Vascular Medicine (ESVM), emphasize on a comprehensive and multidisciplinary approach focusing on prevention, diagnosis, treatment, and follow-up of patients with a wide range of PAAD, including lower extremity peripheral arterial disease (PAD). The aim of this summary, focusing on PAD and coordinated by the Young Academy of ESVM, is to provide young angiologists with the fundamental principles of these guidelines and to assist them in navigating their everyday clinical practice. PAD diagnosis relies on objective evaluation of flow/oxygen reduction at rest, with arterial ultrasound as the first imaging modality to confirm the presence of arterial lesions. The main goals of PAD management are not only to improve functioning and prevent the occurrence of adverse events at the lower limb level, but also to reduce the overall atherosclerotic burden and achieve the general well-being of patients. To this end, traditional and nontraditional cardiovascular risk factors need to be properly addressed through lifestyle changes and tailored drug therapies. For patients with exertional limb symptoms, supervised exercise training is recommended. Interventional treatment is indicated for limb salvage in patients with chronic limb threatening ischemia and may also be discussed in a multidisciplinary setting in less severe patients with persisting symptoms and reduced quality of life after a minimum period of optimal medical treatment including exercise therapy. For trainees or young specialists in Angiology/Vascular Medicine, these guidelines provide essential elements to improve patient management, encourage interdisciplinary collaboration, and ensure an integrated approach to vascular diseases.
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Affiliation(s)
- Giacomo Buso
- Department of Clinical and Experimental Sciences, Division of Internal Medicine, ASST Spedali Civili Brescia, University of Brescia, Italy
- University of Lausanne, Switzerland
| | - Jeanne Hersant
- Department of Vascular Medicine, University Hospital of Angers, France
| | - Sanjiv Keller
- Angiology Division, Heart and Vessel Department, Lausanne University Hospital, University of Lausanne, Switzerland
| | - Igli Kalaja
- Department for Cardiology III - Angiology, University Medical Center of the Johannes Gutenberg-University, Mainz, Germany
| | - Paola Bigolin
- Angiology Unit, Azienda ULSS 2 Marca Trevigiana, Castelfranco Veneto, Italy
| | - Enrica Porceddu
- Angiology Division, Heart and Vessel Department, Lausanne University Hospital, University of Lausanne, Switzerland
| | | | - Marko Novaković
- Department of Vascular Diseases, University Medical Centre Ljubljana, Slovenia
| | | | - Andrej Džupina
- Department of Cardiology and Angiology, National Institute of Cardiovascular Diseases, Bratislava, Slovakia
| | - Thomas Gary
- Division of Angiology, Department of Internal Medicine, Medical University of Graz, Austria
| | - Alessandra Bura-Rivière
- Department of Vascular Medicine, Toulouse University Hospital, France
- Department of Medicine, Faculté de Santé Université Toulouse III, France
| | - Christian Heiss
- Vascular Department, Surrey and Sussex Healthcare NHS Trust, East Surrey Hospital, Redhill, UK
- Department of Clinical and Experimental Medicine, Faculty of Health and Medical Sciences, University of Surrey, Guildford, UK
| | - Stefano Lanzi
- Angiology Division, Heart and Vessel Department, Lausanne University Hospital, University of Lausanne, Switzerland
| | - Juraj Madaric
- Department of Angiology, Comenius University and National Institute of Cardiovascular Diseases, Bratislava, Slovakia
| | - Vinko Boc
- Department of Vascular Diseases, University Medical Centre Ljubljana, Slovenia
- Department of Internal Medicine, Faculty of Medicine, University of Ljubljana, Slovenia
| | - Muriel Sprynger
- Department of Cardiology, University Hospital of Liège, Belgium
| | - Tristan Mirault
- Université Paris Cité, PARCC Inserm U970, CRMR MARS, VASCERN, Vascular Medicine, Hôpital Européen Georges-Pompidou APHP, Paris, France
| | - Marianne Brodmann
- Division of Angiology, Department of Internal Medicine, Medical University of Graz, Austria
| | - Oliver Schlager
- Division of Angiology, Department of Medicine II, Medical University of Vienna, Austria
| | - Lucia Mazzolai
- Angiology Division, Heart and Vessel Department, Lausanne University Hospital, University of Lausanne, Switzerland
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Hart JP, Davies MG. Transitions of frailty after lower extremity interventions for chronic limb-threatening ischemia. J Vasc Surg 2025; 81:730-742.e4. [PMID: 39613273 DOI: 10.1016/j.jvs.2024.11.025] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/07/2024] [Revised: 11/15/2024] [Accepted: 11/20/2024] [Indexed: 12/01/2024]
Abstract
BACKGROUND Frailty is common among surgical patients and predicts poor surgical outcomes. This study aimed to analyze transitions in frailty state among patients undergoing lower extremity care for chronic limb-threatening ischemia (CLTI). METHODS Between 2018 and 2022, all patients undergoing a primary intervention for CLTI (endovascular intervention [EV], bypass [BYP], major amputation [AMP]) or wound care were analyzed. Frailty was assessed by Vascular Quality Initiative-derived Risk Analysis Index. Frailty was defined as a Vascular Quality Initiative-derived Risk Analysis Index score of ≥35. Transition in frailty state between preoperative and follow-up measurement at 1 month and 1 year were analyzed. Patient characteristics leading to a transition in frailty state were analyzed using multivariable Cox regression analysis. Amputation-free survival (survival without AMP) and freedom from major adverse limb events (above-ankle amputation of the index limb or major re-intervention (new BYP graft, jump/interposition graft revision) were evaluated. RESULTS We included 1859 patients (56% male; mean age, 65 ± 11 years) who underwent either EV (52%), a BYP (29%), AMP (13%), or wound care (6%). Amon them, 25% were considered frail on initial evaluation (28%, 16%, 32%, and 30% EV, BYP, AMP, and wound care, respectively). At 30 days, overall frailty increased to 34%: 13% of patients moved from nonfrail to frail (9%, 18%, 22%, and 5% for EV, BYP, AMP, and wound care, respectively), and 4% of patients moved from frail to nonfrail (6%, 2%, 1%, and 0% for EV, BYP, AMP, and wound care, respectively). At 1 year, overall frailty increased to 40%: an additional 13% of patients shifted from nonfrail to frail (15%, 6%, 23%, and 8% for EV, BYP, AMP, and wound care, respectively), and 5% of patients shifted from frail to nonfrail (4%, 8%, 2%, and 0% for EV, BYP, AMP, and wound care, respectively). At 1 year, frailty increased by 28% in EV, 16% for BYP, 32% in AMP, and 43% in wound care. Frailty at baseline, 30 days, and 1 year was associated with a high Charlson's Comorbidity Index. Shifting to a frail state postoperatively was associated with decreased survival and a lower amputation-free survival at 1 year. CONCLUSIONS After major interventions for CLTI at 1 year, 27% of patients shift from a nonfrail to a frail state, and 9% of patients shift from a frail to a nonfrail state with differences across modalities in comparison to wound care, where 13% of patients moved from a nonfrail to a frail state, and none shifted from a frail to a nonfrail state. Shifting to a frail state after intervention is associated with poor outcomes and should be considered when evaluating and intervention in a patient with CLTI.
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Affiliation(s)
- Joseph P Hart
- Center for Quality, Effectiveness, and Outcomes in Cardiovascular Diseases, Houston, TX; Division of Vascular Surgery, Medical College of Wisconsin, Milwaukee, WI
| | - Mark G Davies
- Center for Quality, Effectiveness, and Outcomes in Cardiovascular Diseases, Houston, TX; Department of Vascular and Endovascular Surgery, Ascension Health, Waco, TX.
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6
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Martin SS, Aday AW, Allen NB, Almarzooq ZI, Anderson CAM, Arora P, Avery CL, Baker-Smith CM, Bansal N, Beaton AZ, Commodore-Mensah Y, Currie ME, Elkind MSV, Fan W, Generoso G, Gibbs BB, Heard DG, Hiremath S, Johansen MC, Kazi DS, Ko D, Leppert MH, Magnani JW, Michos ED, Mussolino ME, Parikh NI, Perman SM, Rezk-Hanna M, Roth GA, Shah NS, Springer MV, St-Onge MP, Thacker EL, Urbut SM, Van Spall HGC, Voeks JH, Whelton SP, Wong ND, Wong SS, Yaffe K, Palaniappan LP. 2025 Heart Disease and Stroke Statistics: A Report of US and Global Data From the American Heart Association. Circulation 2025; 151:e41-e660. [PMID: 39866113 DOI: 10.1161/cir.0000000000001303] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/28/2025]
Abstract
BACKGROUND The American Heart Association (AHA), in conjunction with the National Institutes of Health, annually reports the most up-to-date statistics related to heart disease, stroke, and cardiovascular risk factors, including core health behaviors (smoking, physical activity, nutrition, sleep, and obesity) and health factors (cholesterol, blood pressure, glucose control, and metabolic syndrome) that contribute to cardiovascular health. The AHA Heart Disease and Stroke Statistical Update presents the latest data on a range of major clinical heart and circulatory disease conditions (including stroke, brain health, complications of pregnancy, kidney disease, congenital heart disease, rhythm disorders, sudden cardiac arrest, subclinical atherosclerosis, coronary heart disease, cardiomyopathy, heart failure, valvular disease, venous thromboembolism, and peripheral artery disease) and the associated outcomes (including quality of care, procedures, and economic costs). METHODS The AHA, through its Epidemiology and Prevention Statistics Committee, continuously monitors and evaluates sources of data on heart disease and stroke in the United States and globally to provide the most current information available in the annual Statistical Update with review of published literature through the year before writing. The 2025 AHA Statistical Update is the product of a full year's worth of effort in 2024 by dedicated volunteer clinicians and scientists, committed government professionals, and AHA staff members. This year's edition includes a continued focus on health equity across several key domains and enhanced global data that reflect improved methods and incorporation of ≈3000 new data sources since last year's Statistical Update. RESULTS Each of the chapters in the Statistical Update focuses on a different topic related to heart disease and stroke statistics. CONCLUSIONS The Statistical Update represents a critical resource for the lay public, policymakers, media professionals, clinicians, health care administrators, researchers, health advocates, and others seeking the best available data on these factors and conditions.
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7
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Cohoon KP, Henkin S, Tomihama RT, Thomas SE, Porres-Aguilar M, Brunton NE, Hornacek D, Secemsky EA. Implementing the 2024 ACC/AHA Multisocietal PAD guidelines into clinical practice: Key changes from the 2016 guidelines. Vasc Med 2025; 30:110-113. [PMID: 39713878 DOI: 10.1177/1358863x241306354] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/24/2024]
Affiliation(s)
- Kevin P Cohoon
- Department of Internal Medicine, Division of Cardiovascular Diseases, Medical College of Wisconsin, Milwaukee, WI, USA
| | | | - Roger T Tomihama
- Department of Radiological Sciences, VA Long Beach Healthcare System, University of California, Irvine, CA, USA
| | - Sneha E Thomas
- Department of Vascular Medicine, Riverside University Health System, Moreno Valley, CA, USA
| | - Mateo Porres-Aguilar
- Department of Medicine, Divisions of Adult Thrombosis and Hospital Medicine, Texas Tech University Health Sciences Center and Paul L Foster School of Medicine, El Paso, TX, USA
| | - Nichole E Brunton
- Cardiovascular Medicine Fellow, Virginia Commonwealth University, Richmond, VA, USA
| | - Deborah Hornacek
- Department of Cardiovascular Medicine, Section of Vascular Medicine, Cleveland Clinic, Cleveland, OH, USA
| | - Eric A Secemsky
- Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Boston, MA, USA
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8
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Schulze-Bauer H, Staudacher M, Steiner S, Schlager O. [What is new in the management of peripheral arterial occlusive disease and diseases of the aorta? : Highlights of the ESC guidelines 2024]. Herz 2025; 50:25-33. [PMID: 39589444 PMCID: PMC11772412 DOI: 10.1007/s00059-024-05286-7] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 10/22/2024] [Indexed: 11/27/2024]
Abstract
The European Society of Cardiology (ESC) guidelines on peripheral arterial disease (PAD) and diseases of the aorta published in September 2024 for the first time combine recommendations for both diseases in a joint guideline document. The consolidation of PAD and aorta guidelines follows a holistic approach, which underlines the entirety of the arterial vascular system. This aim is underlined by a specifically introduced recommendation to take the entirety of the circulatory system into account in patients with vascular diseases. The focus in the current ESC guideline document is on a multidisciplinary, patient-centered management of PAD and diseases of the aorta, whereby the prevention and follow-up of patients after therapeutic interventions are emphasized. In PAD the document highlights exercise training and the procedure for patients with chronic wounds as well as risk stratification and hereditary diseases of the aorta.
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Affiliation(s)
- Heike Schulze-Bauer
- Klinische Abteilung für Angiologie, Universitätsklinik für Innere Medizin II, Medizinische Universität Wien, Währinger Gürtel 18-20, 1090, Wien, Österreich
| | - Moritz Staudacher
- Klinische Abteilung für Angiologie, Universitätsklinik für Innere Medizin II, Medizinische Universität Wien, Währinger Gürtel 18-20, 1090, Wien, Österreich
| | - Sabine Steiner
- Klinische Abteilung für Angiologie, Universitätsklinik für Innere Medizin II, Medizinische Universität Wien, Währinger Gürtel 18-20, 1090, Wien, Österreich
| | - Oliver Schlager
- Klinische Abteilung für Angiologie, Universitätsklinik für Innere Medizin II, Medizinische Universität Wien, Währinger Gürtel 18-20, 1090, Wien, Österreich.
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9
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Wang P, Di X, Li F, Rong Z, Lian W, Li Z, Chen T, Wang W, Zhong Q, Sun G, Ni L, Liu C. Platelet Membrane-Coated HGF-PLGA Nanoparticles Promote Therapeutic Angiogenesis and Tissue Perfusion Recovery in Ischemic Hindlimbs. ACS APPLIED BIO MATERIALS 2025; 8:399-409. [PMID: 39723905 PMCID: PMC11753260 DOI: 10.1021/acsabm.4c01373] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/21/2024] [Revised: 12/01/2024] [Accepted: 12/02/2024] [Indexed: 12/28/2024]
Abstract
Therapeutic angiogenesis has garnered significant attention as a potential treatment strategy for lower limb ischemic diseases. Although hepatocyte growth factor (HGF) has been identified as a key promoter of therapeutic angiogenesis, its clinical application is limited due to its short half-life. In this study, we successfully developed and characterized platelet membrane-coated HGF-poly(lactic-co-glycolic acid) (PLGA) nanoparticles (NPs). These nanoparticles demonstrated enhanced capabilities to promote endothelial cell (EC) proliferation, migration, and tube formation in vitro. Additionally, their efficacy in improving tissue perfusion and promoting angiogenesis was confirmed in a hindlimb ischemia rat model. Our findings suggest that platelet membrane-coated HGF-PLGA-NPs could serve as a promising therapeutic approach for enhancing angiogenesis and restoring tissue perfusion in ischemic conditions.
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Affiliation(s)
- Peng Wang
- Department
of Vascular Surgery, Peking Union Medical
College Hospital, Chinese Academy of Medical Science and Peking Union
Medical College, No. 1 Shuaifuyuan Hutong, Dongcheng District, Beijing 100730, China
| | - Xiao Di
- Department
of Vascular Surgery, Peking Union Medical
College Hospital, Chinese Academy of Medical Science and Peking Union
Medical College, No. 1 Shuaifuyuan Hutong, Dongcheng District, Beijing 100730, China
| | - Fengshi Li
- Department
of Vascular Surgery, Shanghai Ninth People’s
Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200011, China
| | - Zhihua Rong
- Department
of Vascular Surgery, Beijing Anzhen Hospital,
Capital Medical University, Beijing 100029, China
| | - Wenzhuo Lian
- Department
of Vascular Surgery, Peking Union Medical
College Hospital, Chinese Academy of Medical Science and Peking Union
Medical College, No. 1 Shuaifuyuan Hutong, Dongcheng District, Beijing 100730, China
| | - Zongshu Li
- Biomedical
Engineering Facility of National Infrastructures for Translational
Medicine, Institute of Clinical Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical
Sciences and Peking Union Medical College, Beijing 100730, China
| | - Tianqi Chen
- Biomedical
Engineering Facility of National Infrastructures for Translational
Medicine, Institute of Clinical Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical
Sciences and Peking Union Medical College, Beijing 100730, China
| | - Wenjing Wang
- Laboratory
Animal Research Facility, National Infrastructures for Translational
Medicine, Institute of Clinical Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical
Science and Peking Union Medical College, Beijing 100730, China
| | - Qing Zhong
- Biomedical
Engineering Facility of National Infrastructures for Translational
Medicine, Institute of Clinical Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical
Sciences and Peking Union Medical College, Beijing 100730, China
| | - Guoqiang Sun
- Department
of Information Center, Peking Union Medical
College Hospital, Chinese Academy of Medical Science and Peking Union
Medical College, No.
1 Shuaifuyuan Hutong, Dongcheng District, Beijing 100730, China
| | - Leng Ni
- Department
of Vascular Surgery, Peking Union Medical
College Hospital, Chinese Academy of Medical Science and Peking Union
Medical College, No. 1 Shuaifuyuan Hutong, Dongcheng District, Beijing 100730, China
| | - ChangWei Liu
- Department
of Vascular Surgery, Peking Union Medical
College Hospital, Chinese Academy of Medical Science and Peking Union
Medical College, No. 1 Shuaifuyuan Hutong, Dongcheng District, Beijing 100730, China
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10
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Nyman J, Hasselmann J, Monsen C, Acosta S. Staged versus nonstaged elective hybrid iliofemoral revascularization - analysis of ten years of prospective data. Ann Vasc Surg 2025; 110:159-168. [PMID: 39009127 DOI: 10.1016/j.avsg.2024.05.036] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/01/2024] [Revised: 04/29/2024] [Accepted: 05/24/2024] [Indexed: 07/17/2024]
Abstract
BACKGROUND Reports of large series of hybrid iliofemoral revascularization for chronic lower limb ischemia are scarce. The aims of this study were to evaluate outcomes for staged and nonstaged procedures, and to evaluate risk factors for outcomes at 90 days. METHODS Patients were consecutively included between 2013 and 2023. Surgical site infection (SSI) was defined by the ASEPSIS criteria and major adverse limb events (MALE) as onset of acute or continuing or worsening chronic limb ischemia or major amputation. Factors associated with outcomes were tested in a multivariable logistic regression analysis and expressed in odds ratios (ORs) with 95% confidence intervals (CIs). RESULTS Patients undergoing nonstaged procedures (n = 124) had higher Trans-Atlantic Inter-Society Consensus (TASC) class representing anatomical occlusive complexity, more often through-and through femoral guidewire access, more endoprosthesis, more covered stents, longer procedure time with open groin wounds, and less contralateral femoral access, than those undergoing staged procedures (n = 31). The median time interval between the staged procedures was 1 day, and iliac stenting was done first in 77%. The median in-hospital stay was nonsignificantly longer in staged procedure (8 vs. 6 days, P = 0.053). The overall SSI and MALE rates were 25.8% and 20.0%, respectively, without differences between groups. Diabetes mellitus (OR 3.7, 95% CI 1.2-7.2]) and presence of a foot ulcer (OR 3.7, 95% CI [1.5-9.4]) were independently associated with MALE at 90 days. Postoperative hyperglycemia was nonsignificantly associated with SSI (OR 2.1 (95% CI 1.0-4.5), P = 0.066) in multivariable analysis. CONCLUSIONS The risks of SSI and MALE after elective hybrid iliofemoral revascularization were high. There appears to be no benefit in performing staged as opposed to nonstaged procedures. The extent of iliofemoral occlusive disease according to the TASC classification had little influence on outcomes whereas diabetes mellitus and presence of a foot ulcer had greater impact on MALE.
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Affiliation(s)
- Johan Nyman
- Vascular Centre, Department of Cardiothoracic and Vascular Surgery, Skane University Hospital, Malmö, Sweden; Department of Clinical Sciences, Malmö, Lund University, Malmö, Sweden.
| | - Julien Hasselmann
- Department of Clinical Sciences, Malmö, Lund University, Malmö, Sweden
| | - Christina Monsen
- Department of Allied Health Professions, Skane University Hospital, Malmö, Sweden
| | - Stefan Acosta
- Vascular Centre, Department of Cardiothoracic and Vascular Surgery, Skane University Hospital, Malmö, Sweden; Department of Clinical Sciences, Malmö, Lund University, Malmö, Sweden
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de la Cruz-Ares S, Coronado-Carvajal MDP, Rangel-Zúñiga OA, Torres-Peña JD, Arenas-de Larriva AP, López-Moreno A, Katsiki N, Ordovás JM, Delgado-Lista J, López-Martínez P, Gutiérrez-Mariscal FM, López-Miranda J. Lipoprotein particle profile in the presence of peripheral artery disease among patients with coronary heart disease: Data from the CORDIOPREV study. J Clin Lipidol 2024:S1933-2874(24)00292-7. [PMID: 39924421 DOI: 10.1016/j.jacl.2024.12.007] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/26/2024] [Revised: 10/30/2024] [Accepted: 12/09/2024] [Indexed: 02/11/2025]
Abstract
BACKGROUND Dyslipidemia is recognized as a contributing factor to peripheral artery disease (PAD). However, the influence of lipoprotein subfractions as compared to traditional serum lipid levels is not well-understood. OBJECTIVE This study explores the association between lipoprotein subfractions and the occurrence of PAD in patients with coronary heart disease (CHD). METHODS In the CORDIOPREV study, 981 patients were categorized based on PAD diagnosis, determined by an ankle-brachial index (ABI) ≤0.9. Those with ABI >0.9 and <1.4 were considered PAD-free, while patients with ABI ≥1.4 were excluded. We employed high-throughput nuclear magnetic resonance (NMR) spectroscopy to analyze the concentration and lipid content of lipoprotein subfractions. RESULTS PAD patients exhibited significantly lower levels of medium high-density lipoprotein (HDL) particles and reduced concentrations of associated lipids within these subfractions except for triglycerides. A higher concentration of large or medium HDL particles correlated with a lower PAD prevalence (OR: 0.61, 95% CI, 0.44-0.84; OR: 0.59, 95% CI, 0.43-0.81, respectively). In multivariate logistic regression, medium HDL particle levels inversely associated with PAD presence (OR: 0.69, 95% CI, 0.48-0.99, P = .044) after adjustment for confounding factors. CONCLUSIONS The presence of PAD among CHD patients inversely correlates with medium HDL particle concentrations as determined by NMR. These insights could advance our understanding of PAD pathophysiology and HDL metabolism.
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Affiliation(s)
- Silvia de la Cruz-Ares
- Lipids and Atherosclerosis Unit, Internal Medicine Unit, Reina Sofia University Hospital (Drs de la Cruz-Ares, Coronado-Carvajal, Rangel-Zúñiga, Torres-Peña, Arenas-de Larriva, López-Moreno, Delgado-Lista, López-Martínez, Gutiérrez-Mariscal, and López-Miranda), Córdoba, Spain; Maimonides Biomedical Research Institute of Córdoba (IMIBIC) (Drs de la Cruz-Ares, Rangel-Zúñiga, Torres-Peña, Arenas-de Larriva, López-Moreno, Delgado-Lista, López-Martínez, Gutiérrez-Mariscal, and López-Miranda), Córdoba, Spain; Department of Food Science and Technology, University of Córdoba (Drs de la Cruz-Ares), Córdoba, Spain; CIBER fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (Drs de la Cruz-Ares, Rangel-Zúñiga, Torres-Peña, Arenas-de Larriva, López-Moreno, Delgado-Lista, López-Martínez, Gutiérrez-Mariscal, and López-Miranda), Madrid, Spain.
| | - María Del Pilar Coronado-Carvajal
- Lipids and Atherosclerosis Unit, Internal Medicine Unit, Reina Sofia University Hospital (Drs de la Cruz-Ares, Coronado-Carvajal, Rangel-Zúñiga, Torres-Peña, Arenas-de Larriva, López-Moreno, Delgado-Lista, López-Martínez, Gutiérrez-Mariscal, and López-Miranda), Córdoba, Spain; Department of Medical and Surgical Sciences, University of Córdoba (Drs Coronado-Carvajal, Rangel-Zúñiga, Torres-Peña, Arenas-de Larriva, López-Moreno, Delgado-Lista, López-Martínez, Gutiérrez-Mariscal, and López-Miranda), Córdoba, Spain
| | - Oriol Alberto Rangel-Zúñiga
- Lipids and Atherosclerosis Unit, Internal Medicine Unit, Reina Sofia University Hospital (Drs de la Cruz-Ares, Coronado-Carvajal, Rangel-Zúñiga, Torres-Peña, Arenas-de Larriva, López-Moreno, Delgado-Lista, López-Martínez, Gutiérrez-Mariscal, and López-Miranda), Córdoba, Spain; Maimonides Biomedical Research Institute of Córdoba (IMIBIC) (Drs de la Cruz-Ares, Rangel-Zúñiga, Torres-Peña, Arenas-de Larriva, López-Moreno, Delgado-Lista, López-Martínez, Gutiérrez-Mariscal, and López-Miranda), Córdoba, Spain; Department of Medical and Surgical Sciences, University of Córdoba (Drs Coronado-Carvajal, Rangel-Zúñiga, Torres-Peña, Arenas-de Larriva, López-Moreno, Delgado-Lista, López-Martínez, Gutiérrez-Mariscal, and López-Miranda), Córdoba, Spain; CIBER fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (Drs de la Cruz-Ares, Rangel-Zúñiga, Torres-Peña, Arenas-de Larriva, López-Moreno, Delgado-Lista, López-Martínez, Gutiérrez-Mariscal, and López-Miranda), Madrid, Spain
| | - José David Torres-Peña
- Lipids and Atherosclerosis Unit, Internal Medicine Unit, Reina Sofia University Hospital (Drs de la Cruz-Ares, Coronado-Carvajal, Rangel-Zúñiga, Torres-Peña, Arenas-de Larriva, López-Moreno, Delgado-Lista, López-Martínez, Gutiérrez-Mariscal, and López-Miranda), Córdoba, Spain; Maimonides Biomedical Research Institute of Córdoba (IMIBIC) (Drs de la Cruz-Ares, Rangel-Zúñiga, Torres-Peña, Arenas-de Larriva, López-Moreno, Delgado-Lista, López-Martínez, Gutiérrez-Mariscal, and López-Miranda), Córdoba, Spain; Department of Medical and Surgical Sciences, University of Córdoba (Drs Coronado-Carvajal, Rangel-Zúñiga, Torres-Peña, Arenas-de Larriva, López-Moreno, Delgado-Lista, López-Martínez, Gutiérrez-Mariscal, and López-Miranda), Córdoba, Spain; CIBER fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (Drs de la Cruz-Ares, Rangel-Zúñiga, Torres-Peña, Arenas-de Larriva, López-Moreno, Delgado-Lista, López-Martínez, Gutiérrez-Mariscal, and López-Miranda), Madrid, Spain
| | - Antonio Pablo Arenas-de Larriva
- Lipids and Atherosclerosis Unit, Internal Medicine Unit, Reina Sofia University Hospital (Drs de la Cruz-Ares, Coronado-Carvajal, Rangel-Zúñiga, Torres-Peña, Arenas-de Larriva, López-Moreno, Delgado-Lista, López-Martínez, Gutiérrez-Mariscal, and López-Miranda), Córdoba, Spain; Maimonides Biomedical Research Institute of Córdoba (IMIBIC) (Drs de la Cruz-Ares, Rangel-Zúñiga, Torres-Peña, Arenas-de Larriva, López-Moreno, Delgado-Lista, López-Martínez, Gutiérrez-Mariscal, and López-Miranda), Córdoba, Spain; Department of Medical and Surgical Sciences, University of Córdoba (Drs Coronado-Carvajal, Rangel-Zúñiga, Torres-Peña, Arenas-de Larriva, López-Moreno, Delgado-Lista, López-Martínez, Gutiérrez-Mariscal, and López-Miranda), Córdoba, Spain; CIBER fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (Drs de la Cruz-Ares, Rangel-Zúñiga, Torres-Peña, Arenas-de Larriva, López-Moreno, Delgado-Lista, López-Martínez, Gutiérrez-Mariscal, and López-Miranda), Madrid, Spain
| | - Alejandro López-Moreno
- Lipids and Atherosclerosis Unit, Internal Medicine Unit, Reina Sofia University Hospital (Drs de la Cruz-Ares, Coronado-Carvajal, Rangel-Zúñiga, Torres-Peña, Arenas-de Larriva, López-Moreno, Delgado-Lista, López-Martínez, Gutiérrez-Mariscal, and López-Miranda), Córdoba, Spain; Maimonides Biomedical Research Institute of Córdoba (IMIBIC) (Drs de la Cruz-Ares, Rangel-Zúñiga, Torres-Peña, Arenas-de Larriva, López-Moreno, Delgado-Lista, López-Martínez, Gutiérrez-Mariscal, and López-Miranda), Córdoba, Spain; Department of Medical and Surgical Sciences, University of Córdoba (Drs Coronado-Carvajal, Rangel-Zúñiga, Torres-Peña, Arenas-de Larriva, López-Moreno, Delgado-Lista, López-Martínez, Gutiérrez-Mariscal, and López-Miranda), Córdoba, Spain; CIBER fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (Drs de la Cruz-Ares, Rangel-Zúñiga, Torres-Peña, Arenas-de Larriva, López-Moreno, Delgado-Lista, López-Martínez, Gutiérrez-Mariscal, and López-Miranda), Madrid, Spain
| | - Niki Katsiki
- Department of Nutritional Sciences and Dietetics, International Hellenic University (Dr Katsiki), Thessaloniki, Greece; School of Medicine (Dr Katsiki), European University Cyprus Nicosia, Cyprus
| | - José María Ordovás
- Nutrition and Genomics Laboratory, Human Nutrition Research Center of Aging, Tufts University (Dr Ordovás), Boston, MA, USA
| | - Javier Delgado-Lista
- Lipids and Atherosclerosis Unit, Internal Medicine Unit, Reina Sofia University Hospital (Drs de la Cruz-Ares, Coronado-Carvajal, Rangel-Zúñiga, Torres-Peña, Arenas-de Larriva, López-Moreno, Delgado-Lista, López-Martínez, Gutiérrez-Mariscal, and López-Miranda), Córdoba, Spain; Maimonides Biomedical Research Institute of Córdoba (IMIBIC) (Drs de la Cruz-Ares, Rangel-Zúñiga, Torres-Peña, Arenas-de Larriva, López-Moreno, Delgado-Lista, López-Martínez, Gutiérrez-Mariscal, and López-Miranda), Córdoba, Spain; Department of Medical and Surgical Sciences, University of Córdoba (Drs Coronado-Carvajal, Rangel-Zúñiga, Torres-Peña, Arenas-de Larriva, López-Moreno, Delgado-Lista, López-Martínez, Gutiérrez-Mariscal, and López-Miranda), Córdoba, Spain; CIBER fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (Drs de la Cruz-Ares, Rangel-Zúñiga, Torres-Peña, Arenas-de Larriva, López-Moreno, Delgado-Lista, López-Martínez, Gutiérrez-Mariscal, and López-Miranda), Madrid, Spain
| | - Pablo López-Martínez
- Lipids and Atherosclerosis Unit, Internal Medicine Unit, Reina Sofia University Hospital (Drs de la Cruz-Ares, Coronado-Carvajal, Rangel-Zúñiga, Torres-Peña, Arenas-de Larriva, López-Moreno, Delgado-Lista, López-Martínez, Gutiérrez-Mariscal, and López-Miranda), Córdoba, Spain; Maimonides Biomedical Research Institute of Córdoba (IMIBIC) (Drs de la Cruz-Ares, Rangel-Zúñiga, Torres-Peña, Arenas-de Larriva, López-Moreno, Delgado-Lista, López-Martínez, Gutiérrez-Mariscal, and López-Miranda), Córdoba, Spain; Department of Medical and Surgical Sciences, University of Córdoba (Drs Coronado-Carvajal, Rangel-Zúñiga, Torres-Peña, Arenas-de Larriva, López-Moreno, Delgado-Lista, López-Martínez, Gutiérrez-Mariscal, and López-Miranda), Córdoba, Spain; CIBER fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (Drs de la Cruz-Ares, Rangel-Zúñiga, Torres-Peña, Arenas-de Larriva, López-Moreno, Delgado-Lista, López-Martínez, Gutiérrez-Mariscal, and López-Miranda), Madrid, Spain
| | - Francisco Miguel Gutiérrez-Mariscal
- Lipids and Atherosclerosis Unit, Internal Medicine Unit, Reina Sofia University Hospital (Drs de la Cruz-Ares, Coronado-Carvajal, Rangel-Zúñiga, Torres-Peña, Arenas-de Larriva, López-Moreno, Delgado-Lista, López-Martínez, Gutiérrez-Mariscal, and López-Miranda), Córdoba, Spain; Maimonides Biomedical Research Institute of Córdoba (IMIBIC) (Drs de la Cruz-Ares, Rangel-Zúñiga, Torres-Peña, Arenas-de Larriva, López-Moreno, Delgado-Lista, López-Martínez, Gutiérrez-Mariscal, and López-Miranda), Córdoba, Spain; Department of Medical and Surgical Sciences, University of Córdoba (Drs Coronado-Carvajal, Rangel-Zúñiga, Torres-Peña, Arenas-de Larriva, López-Moreno, Delgado-Lista, López-Martínez, Gutiérrez-Mariscal, and López-Miranda), Córdoba, Spain; CIBER fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (Drs de la Cruz-Ares, Rangel-Zúñiga, Torres-Peña, Arenas-de Larriva, López-Moreno, Delgado-Lista, López-Martínez, Gutiérrez-Mariscal, and López-Miranda), Madrid, Spain
| | - José López-Miranda
- Lipids and Atherosclerosis Unit, Internal Medicine Unit, Reina Sofia University Hospital (Drs de la Cruz-Ares, Coronado-Carvajal, Rangel-Zúñiga, Torres-Peña, Arenas-de Larriva, López-Moreno, Delgado-Lista, López-Martínez, Gutiérrez-Mariscal, and López-Miranda), Córdoba, Spain; Maimonides Biomedical Research Institute of Córdoba (IMIBIC) (Drs de la Cruz-Ares, Rangel-Zúñiga, Torres-Peña, Arenas-de Larriva, López-Moreno, Delgado-Lista, López-Martínez, Gutiérrez-Mariscal, and López-Miranda), Córdoba, Spain; Department of Medical and Surgical Sciences, University of Córdoba (Drs Coronado-Carvajal, Rangel-Zúñiga, Torres-Peña, Arenas-de Larriva, López-Moreno, Delgado-Lista, López-Martínez, Gutiérrez-Mariscal, and López-Miranda), Córdoba, Spain; CIBER fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III (Drs de la Cruz-Ares, Rangel-Zúñiga, Torres-Peña, Arenas-de Larriva, López-Moreno, Delgado-Lista, López-Martínez, Gutiérrez-Mariscal, and López-Miranda), Madrid, Spain.
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Ageno W, Caramelli B, Donadini MP, Girardi L, Riva N. Changes in the landscape of anticoagulation: a focus on direct oral anticoagulants. Lancet Haematol 2024; 11:e938-e950. [PMID: 39433055 DOI: 10.1016/s2352-3026(24)00281-3] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/07/2024] [Revised: 08/27/2024] [Accepted: 08/30/2024] [Indexed: 10/23/2024]
Abstract
Over the last decade, the advent of direct oral anticoagulants (DOACs) has rapidly changed the landscape of anticoagulation. In the early 2010s, DOACs became widely available for stroke prevention in atrial fibrillation and the treatment of venous thromboembolism. About 10 years later, approximately two-thirds of patients requiring oral anticoagulant treatment were receiving a DOAC. The results of several post-marketing studies consistently confirmed the findings of phase 3 clinical trials, and research has focused on new areas of development, with heterogeneous results. A role for DOACs has emerged for patients with peripheral artery disease and other challenging conditions, such as cancer-associated thrombosis, unusual-site venous thromboembolism, and end-stage renal disease. Conversely, clinical trials showed that DOACs were not efficacious in patients with valvular atrial fibrillation, mechanical heart valves, embolic strokes of undetermined source, or antiphospholipid syndrome. In this Review, we discuss the impact of DOACs in clinical practice over the last decade, new areas under development, and practical issues in the management of these drugs.
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Affiliation(s)
- Walter Ageno
- Department of Internal Medicine, Ospedale Regionale di Bellinzona e Valli, Bellinzona, Switzerland; Department of Medicine and Surgery, University of Insubria, Varese, Italy.
| | - Bruno Caramelli
- Unidade de Medicina Interdisciplinar em Cardiologia, Instituto do Coração, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil
| | | | - Laura Girardi
- Department of Medicine and Surgery, University of Insubria, Varese, Italy
| | - Nicoletta Riva
- Department of Pathology, Faculty of Medicine and Surgery, University of Malta, Msida, Malta
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13
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Amlani V, Ludwigs K, Rawshani A, Thuresson M, Falkenberg M, Smidfelt K, Nordanstig J. Editor's Choice - Major Adverse Limb Events in Patients Undergoing Revascularisation for Lower Limb Peripheral Arterial Disease: A Nationwide Observational Study. Eur J Vasc Endovasc Surg 2024; 68:737-745. [PMID: 39121905 DOI: 10.1016/j.ejvs.2024.07.041] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/20/2024] [Revised: 06/26/2024] [Accepted: 07/30/2024] [Indexed: 08/12/2024]
Abstract
OBJECTIVE Major adverse limb events (MALEs) are frequent in patients with lower extremity peripheral arterial disease (PAD). However, routine care MALE rate estimations after revascularisation are scarce. This study aimed to determine post-procedural MALE rates in revascularised patients with PAD and identify predictors of post-procedural MALEs. METHODS This was a population based observational study on merged national registry data. Patients with PAD undergoing lower limb revascularisation between 2008 and 2016 were retrieved from the Swedish National Registry for Vascular Surgery. Information on comorbidities, medications, and post-procedural MALE endpoints were identified in national healthcare registries. Primary outcomes of interest were categorised as 2 - 4 point MALE composites that included limb amputation, acute lower limb ischaemia, progression to or relapse of chronic limb threatening ischaemia (CLTI), and ipsilateral re-interventions regardless of indication. Patients with intermittent claudication (IC) and CLTI were analysed separately using Kaplan-Meier estimates. Stepwise Cox proportional hazard models were used for predictor candidate analysis. RESULTS Overall, 28 021 revascularised patients with PAD were analysed (IC, n = 10 506, 37.5%; CLTI, n = 17 515, 62.5%). During a mean follow up ± standard deviation of 3.2 ± 2.4 years, 5 226 (18.7%), 9 423 (33.6%), and 12 696 (45.3%) patients experienced a 2, 3, and 4 point MALE, respectively. The estimated one year 4 point MALE rates were 21.4% (95% confidence interval [CI] 20.6 - 22.2%) in IC and 46.9% (95% CI 46.1 - 47.7%) in CLTI. Adjusted predictors for experiencing a 4 point MALE in IC were chronic kidney disease (CKD) (hazard ratio [HR] 1.33, 95% CI 1.12 - 1.59) and previous lower limb revascularisation (HR 1.29, 95% CI 1.19 - 1.40). In CLTI, previous contralateral lower limb amputation (HR 1.60, 95% CI 1.47 - 1.73) and CKD (HR 1.25, 95% CI 1.17 - 1.34) were adjusted predictors. CONCLUSION This study emphasises the very high MALE rates in revascularised patients with lower limb PAD, especially in CLTI. Prior lower limb revascularisation correlated with increased MALE rates in IC patients, while prior lower limb amputation was linked to subsequent MALEs in CLTI. In both IC and CLTI, CKD was associated with poorer outcomes, regardless of applied MALE definition.
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Affiliation(s)
- Vishal Amlani
- Department of Molecular and Clinical Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Department of Vascular Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden
| | - Karin Ludwigs
- Department of Radiology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Section of Vascular Surgery, Surgical Clinic, Hallands Hospital, Halmstad, Sweden
| | - Aidin Rawshani
- Department of Molecular and Clinical Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
| | | | - Mårten Falkenberg
- Department of Radiology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Department of Radiology, Region Västra Götaland, Sahlgrenska University Hospital, Gothenburg, Sweden
| | - Kristian Smidfelt
- Department of Molecular and Clinical Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Department of Vascular Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden
| | - Joakim Nordanstig
- Department of Molecular and Clinical Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Department of Vascular Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden.
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Rao P, O'Meara R, Kang I, Cichocki MN, Kittrell Z, Weise LB, Babrowski T, Blecha M. Risk score for one-year mortality following emergent infra-inguinal bypass. J Vasc Surg 2024; 80:1553-1568.e1. [PMID: 38782215 DOI: 10.1016/j.jvs.2024.05.039] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/14/2024] [Revised: 05/15/2024] [Accepted: 05/16/2024] [Indexed: 05/25/2024]
Abstract
OBJECTIVE The purpose of this study is to identify variables that place patients at higher risk for mortality following emergent infra-inguinal bypass. Further, this study will create a risk score for mortality following emergent infra-inguinal bypass to help tailor postoperative and long-term patient management. METHODS In the Vascular Quality Initiative, we identified 2126 patients who underwent emergent infra-inguinal artery bypass. Two primary outcomes were investigated: 30 day mortality following emergent infra-inguinal bypass; and 1-year mortality following emergent infra-inguinal bypass. The first step in analysis was univariable analysis for each outcome with χ2 analysis for categorical variables and Student t-test for comparison of means of ordinal variables. Next, binary logistic regression analysis was performed for each outcome utilizing variables that achieved a univariable P value ≤ .10. Factors with a multivariable P value ≤ .05 were included in the risk score, and points were weighted and assigned based on the respective regression beta-coefficient in the multivariable regression. RESULTS Variables with a significant multivariable association (P < .05) with 1-year mortality were: increasing age; body mass index less than 20 kg/m2; coronary artery disease; active hemodialysis at time of presentation; anemia at admission; prosthetic conduit for emergent bypass; postoperative myocardial infarction; postoperative acute renal insufficiency; perioperative stroke; baseline non-ambulatory status; new onset hemodialysis requirement perioperatively; need for bypass revision or thrombectomy during index admission; lack of statin prescription at discharge; lack of antiplatelet medication at discharge; and, lack of anticoagulation at time of hospital discharge. Pertinent negatives included all sociodemographic variables including rural living status, insurance status, and Area Deprivation Index home area. The risk score achieved an area under the curve of 0.820, and regression analysis of the risk score achieved an overall accuracy of 87.9% with 97.7% accuracy in predicting survival, indicating the model performs better in determining which patients will survive rather than precisely determining who will experience 1-year mortality. CONCLUSIONS Discharge medications are the primary modifiable variable impacting survival after emergent infra-inguinal bypass surgery. In the absence of contraindication, all these patients should be discharged on antiplatelet, statin, and anticoagulant medications after emergent infra-inguinal bypass as they significantly enhance survival. Social determinants of health do not impact survival among patients treated with emergent infra-inguinal bypass at Vascular Quality Initiative centers. A risk score for mortality at 1 year after emergent infra-inguinal bypass has been created that has excellent accuracy.
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Affiliation(s)
- Priya Rao
- Division of Vascular Surgery and Endovascular Therapy, Stritch School of Medicine, Loyola University Chicago, Loyola University Health System, Maywood, IL
| | - Rylie O'Meara
- Division of Vascular Surgery and Endovascular Therapy, Stritch School of Medicine, Loyola University Chicago, Loyola University Health System, Maywood, IL
| | - Ian Kang
- Division of Vascular Surgery and Endovascular Therapy, Stritch School of Medicine, Loyola University Chicago, Loyola University Health System, Maywood, IL
| | - Meghan N Cichocki
- Division of Vascular Surgery and Endovascular Therapy, Stritch School of Medicine, Loyola University Chicago, Loyola University Health System, Maywood, IL
| | - Zach Kittrell
- Division of Vascular Surgery and Endovascular Therapy, Stritch School of Medicine, Loyola University Chicago, Loyola University Health System, Maywood, IL
| | - Lorela B Weise
- Division of Vascular Surgery and Endovascular Therapy, Stritch School of Medicine, Loyola University Chicago, Loyola University Health System, Maywood, IL
| | - Trissa Babrowski
- Division of Vascular Surgery and Endovascular Therapy, University of Chicago Medical Center, Chicago, IL
| | - Matthew Blecha
- Division of Vascular Surgery and Endovascular Therapy, Stritch School of Medicine, Loyola University Chicago, Loyola University Health System, Maywood, IL.
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Vallejo-Vaz AJ, Dharmayat KI, Nzeakor N, Carrasco CP, Fatoba ST, Fonseca MJ, Tolani E, Lee C, Ray KK. Recurrent cardiovascular and limb events in 294,428 patients with coronary or peripheral artery disease or ischemic stroke on antiplatelet monotherapy: The RESRISK cohort study. Atherosclerosis 2024; 398:118589. [PMID: 39277962 DOI: 10.1016/j.atherosclerosis.2024.118589] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/01/2024] [Revised: 07/29/2024] [Accepted: 09/03/2024] [Indexed: 09/17/2024]
Abstract
BACKGROUND AND AIMS Utilising real-world data, we quantified the burden of cardiovascular risk factors and long-term residual risk of atherothrombotic events among routine care cohorts with coronary (CAD) or peripheral (PAD) artery disease or ischemic stroke (IS) on guideline-recommended antiplatelet monotherapy (APMT). METHODS Retrospective cohort study using data (2010-2020) from the United Kingdom Clinical Practice Research Datalink (CPRD) and Hospital Episode Statistics, including adults with CAD, PAD or IS who were first prescribed APMT (CAD/IS: aspirin; PAD: clopidogrel). Primary outcomes (recurrent events): major adverse cardiovascular events (MACE) for CAD/PAD/IS cohorts, major adverse limb events (MALE) for PAD. RESULTS 266,478 CAD, 13,162 PAD, and 14,788 IS patients were included (mean age: 71 years; women 37.7%-47.5 %). Risk factor burden was high and attainment of recommended goals was low. There were 73,691, 3,121 and 7,137 MACE among CAD, PAD and IS patients, respectively (median follow-up: 89.9, 42.4 and 75.9 months, respectively), and 4,767 MALE among PAD patients. MACE incidence rate per 1000 person-years was higher in IS (268.7; 95%CI 265.3-272.0) than CAD (92.9; 95%CI 92.5-93.4) or PAD cohorts (97.2; 95%CI 94.6-99.8). MALE incidence rate was 195.9 (95%CI 192.2-199.6) per 1000 person-years. IS patients presented a lower rate of hospitalisations and longer time-to-first hospitalisation, but once hospitalised, they had a longer length-of-stay. PAD patients had the highest hospitalisation rate. CONCLUSIONS Among a contemporary cohort with cardiovascular disease on APMT, long-term residual atherothrombotic risk remains high despite being on APMT. Greater attention to risk factor control and use of appropriate evidence-based therapy is required to reduce residual risk among this very high-risk population.
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Affiliation(s)
- Antonio J Vallejo-Vaz
- Department of Primary Care and Public Health, School of Public Health, Imperial College London, London, United Kingdom; Department of Medicine, Faculty of Medicine, Universidad de Sevilla, Sevilla, Spain; Clinical Epidemiology and Vascular Risk, Instituto de Biomedicina de Sevilla (IBiS), IBiS/Hospital Universitario Virgen Del Rocío/Universidad de Sevilla/CSIC, Sevilla, Spain; Centro de Investigación Biomédica en Red (CIBER) de Epidemiología y Salud Pública, Instituto de Salud Carlos III, Spain.
| | - Kanika I Dharmayat
- Department of Primary Care and Public Health, School of Public Health, Imperial College London, London, United Kingdom
| | | | | | | | - Maria J Fonseca
- EMEA Real World Methods & Evidence Generation, IQVIA, Lisbon, Portugal
| | - Esther Tolani
- EMEA Real World Methods & Evidence Generation, IQVIA, London, United Kingdom
| | - Christopher Lee
- EMEA Real World Methods & Evidence Generation, IQVIA, London, United Kingdom
| | - Kausik K Ray
- Department of Primary Care and Public Health, School of Public Health, Imperial College London, London, United Kingdom
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Erzinger FL, Polimanti AC, Pinto DM, Murta G, Cury MV, da Silva RB, Biagioni RB, Belckzac SQ, Joviliano EE, de Araujo WJB, de Oliveira JCP. Brazilian Society of Angiology and Vascular Surgery guidelines on peripheral artery disease. J Vasc Bras 2024; 23:e20230059. [PMID: 39493832 PMCID: PMC11530000 DOI: 10.1590/1677-5449.202300592] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/29/2023] [Accepted: 12/04/2023] [Indexed: 11/05/2024] Open
Abstract
Patients with peripheral artery disease and generalized atherosclerosis are at high risk of cardiovascular and limb complications, affecting both quality of life and longevity. Lower limb atherosclerotic disease is associated with high cardiovascular morbidity and mortality and adequate management is founded on treatments involving patient-dependent factors, such as lifestyle changes, and physician-dependent factors, such as clinical treatment, endovascular treatment, or conventional surgery. Medical management of peripheral artery disease is multifaceted, and its most important elements are reduction of cholesterol level, antithrombotic therapy, control of arterial blood pressure, control of diabetes, and smoking cessation. Adhesion to this regime can reduce complications related to the limbs, such as chronic limb-threatening ischemia, that can result in amputation, and the systemic complications of atherosclerosis, such as stroke and myocardial infarction.
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Affiliation(s)
- Fabiano Luiz Erzinger
- Hospital Erasto Gaertner, Serviço de Cirurgia Vascular, Curitiba, PR, Brasil.
- Sociedade Brasileira de Angiologia e de Cirurgia Vascular – SBACV-PR, Curitiba, PR, Brasil.
- Instituto da Circulação, Curitiba, PR, Brasil.
| | - Afonso César Polimanti
- Sociedade Brasileira de Angiologia e de Cirurgia Vascular – SBACV-SP, São Paulo, SP, Brasil.
| | - Daniel Mendes Pinto
- Sociedade Brasileira de Angiologia e de Cirurgia Vascular – SBACV-MG, Belo Horizonte, MG, Brasil.
- Hospital Felicio Rocho Ringgold, Cirurgia Vascular, Belo Horizonte, MG, Brasil.
| | - Gustavo Murta
- Sociedade Brasileira de Angiologia e de Cirurgia Vascular – SBACV-MG, Belo Horizonte, MG, Brasil.
- Rede Mater Dei de Saúde, Cirurgia Vascular, Belo Horizonte, MG, Brasil.
| | - Marcus Vinicius Cury
- Sociedade Brasileira de Angiologia e de Cirurgia Vascular – SBACV-SP, São Paulo, SP, Brasil.
- Instituto de Assistência ao Servidor Público Estadual de São Paulo – IAMPSE, Serviço de Cirurgia Vascular e Endovascular, São Paulo, SP, Brasil.
| | - Ricardo Bernardo da Silva
- Sociedade Brasileira de Angiologia e de Cirurgia Vascular – SBACV-PR, Curitiba, PR, Brasil.
- Pontifícia Universidade Católica do Paraná – PUCPR, Cirurgia Vascular, Curitiba, PR, Brasil.
- Santa Casa de Londrina, Cirurgia Vascular, Londrina, PR, Brasil.
| | - Rodrigo Bruno Biagioni
- Sociedade Brasileira de Angiologia e de Cirurgia Vascular – SBACV-SP, São Paulo, SP, Brasil.
- Instituto de Assistência ao Servidor Público Estadual de São Paulo – IAMPSE, Serviço de Cirurgia Vascular e Endovascular, São Paulo, SP, Brasil.
- Sociedade Brasileira de Radiologia Intervencionista e Cirurgia Endovascular – SOBRICE, São Paulo, SP, Brasil.
| | - Sergio Quilici Belckzac
- Sociedade Brasileira de Angiologia e de Cirurgia Vascular – SBACV-SP, São Paulo, SP, Brasil.
- Instituto de Aprimoramento e Pesquisa em Angiorradiologia e Cirurgia Endovascular – IAPACE, São Paulo, SP, Brasil.
| | - Edwaldo Edner Joviliano
- Sociedade Brasileira de Angiologia e de Cirurgia Vascular – SBACV-SP, São Paulo, SP, Brasil.
- Universidade de São Paulo – USP, Faculdade de Medicina de Ribeirão Preto – FMRP, Ribeirão Preto, SP, Brasil.
| | - Walter Junior Boin de Araujo
- Sociedade Brasileira de Angiologia e de Cirurgia Vascular – SBACV-PR, Curitiba, PR, Brasil.
- Instituto da Circulação, Curitiba, PR, Brasil.
- Universidade Federal do Paraná – UFPR, Hospital das Clínicas – HC, Curitiba, PR, Brasil.
| | - Julio Cesar Peclat de Oliveira
- Sociedade Brasileira de Angiologia e de Cirurgia Vascular – SBACV-SP, São Paulo, SP, Brasil.
- Universidade Federal do Estado do Rio de Janeiro – UNIRIO, Departamento de Cirurgia Vascular, Rio de Janeiro, RJ, Brasil.
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17
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Galli M, Gragnano F, Berteotti M, Marcucci R, Gargiulo G, Calabrò P, Terracciano F, Andreotti F, Patti G, De Caterina R, Capodanno D, Valgimigli M, Mehran R, Perrone Filardi P, Cirillo P, Angiolillo DJ. Antithrombotic Therapy in High Bleeding Risk, Part II: Noncardiac Percutaneous Interventions. JACC Cardiovasc Interv 2024; 17:2325-2336. [PMID: 39477636 DOI: 10.1016/j.jcin.2024.09.011] [Citation(s) in RCA: 1] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/15/2024] [Revised: 08/28/2024] [Accepted: 09/05/2024] [Indexed: 01/07/2025]
Abstract
Over the past decades, there have been great advancements in the antithrombotic management of patients undergoing percutaneous interventions, but most of the available evidence derives from studies conducted in the setting of cardiac interventions. Antithrombotic treatment regimens used in patients undergoing percutaneous cardiac interventions, in particular coronary, are frequently extrapolated to patients undergoing noncardiac interventions. However, the differences in risk profile of the population treated and the types of interventions performed may translate into differences is the safety and efficacy associated with antithrombotic therapy. Noncardiac percutaneous interventions are commonly performed in patients at high bleeding risk, which may indeed impact outcomes, hence underscoring the importance of risk stratification to guide clinical decision-making processes. In this review, we appraise the available evidence on antithrombotic therapy in high-bleeding-risk patients undergoing noncardiac percutaneous interventions.
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Affiliation(s)
- Mattia Galli
- Maria Cecilia Hospital, GVM Care & Research, Cotignola, Italy
| | - Felice Gragnano
- Department of Translational Medical Sciences, University of Campania Luigi Vanvitelli, Caserta, Italy; Division of Clinical Cardiology, A.O.R.N. Sant'Anna e San Sebastiano, Caserta, Italy
| | - Martina Berteotti
- Department of Clinical and Experimental Medicine, University of Florence, Florence, Italy
| | - Rossella Marcucci
- Department of Clinical and Experimental Medicine, University of Florence, Florence, Italy.
| | - Giuseppe Gargiulo
- Department of Advanced Biomedical Sciences, University of Naples Federico II, Naples, Italy
| | - Paolo Calabrò
- Department of Translational Medical Sciences, University of Campania Luigi Vanvitelli, Caserta, Italy; Division of Clinical Cardiology, A.O.R.N. Sant'Anna e San Sebastiano, Caserta, Italy
| | - Fabrizia Terracciano
- Department of Translational Medical Sciences, University of Campania Luigi Vanvitelli, Caserta, Italy; Division of Clinical Cardiology, A.O.R.N. Sant'Anna e San Sebastiano, Caserta, Italy
| | - Felicita Andreotti
- Department of Cardiovascular Sciences, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy; Catholic University Medical School, Rome, Italy
| | - Giuseppe Patti
- Department of Cardiology, Ospedale Maggiore della Carità di Novara, University of Piemonte Orientale, Novara, Italy
| | - Raffaele De Caterina
- Department of Surgical, Medical and Molecular Pathology, University of Pisa, Pisa, Italy; Department of Critical Sciences, University of Pisa, Pisa, Italy
| | - Davide Capodanno
- Division of Cardiology, Azienda Ospedaliero Universitaria Policlinico G. Rodolico-San Marco, University of Catania, Catania, Italy
| | - Marco Valgimigli
- Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Lugano, Switzerland; Department of Biomedical Sciences, University of Italian Switzerland, Lugano, Switzerland
| | - Roxana Mehran
- Icahn School of Medicine at Mount Sinai, New York, New York, USA
| | | | - Plinio Cirillo
- Department of Advanced Biomedical Sciences, University of Naples Federico II, Naples, Italy
| | - Dominick J Angiolillo
- Division of Cardiology, University of Florida College of Medicine, Jacksonville, Florida, USA
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Lin DSH, Wu HP, Chung WJ, Hsueh SK, Hsu PC, Lee JK, Chen CC, Huang HL. Dual Antithrombotic Therapy versus Anticoagulant Monotherapy for Major Adverse Limb Events in Patients with Concomitant Lower Extremity Arterial Disease and Atrial Fibrillation: A Propensity Score Weighted Analysis. Eur J Vasc Endovasc Surg 2024; 68:498-507. [PMID: 38754724 DOI: 10.1016/j.ejvs.2024.05.015] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/29/2023] [Revised: 03/18/2024] [Accepted: 05/09/2024] [Indexed: 05/18/2024]
Abstract
OBJECTIVE Patients with symptomatic lower extremity arterial disease (LEAD) are recommended to receive antiplatelet therapy, while direct oral anticoagulants (DOACs) are standard for stroke prevention in patients with atrial fibrillation (AF). For patients with concomitant LEAD and AF, data comparing dual antithrombotic therapy (an antiplatelet agent used in conjunction with a DOAC) vs. DOAC monotherapy are scarce. This retrospective cohort study, based on data from the Taiwan National Health Insurance Research Database, aimed to compare the efficacy and safety of these antithrombotic strategies. METHODS Patients with AF who underwent revascularisation for LEAD between 2012 - 2020 and received any DOAC within 30 days of discharge were included. Patients were grouped by antiplatelet agent exposure into the dual antithrombotic therapy and DOAC monotherapy groups. Inverse probability of treatment weighting was used to mitigate selection bias. Major adverse limb events (MALEs), ischaemic stroke or systemic embolism, and bleeding outcomes were compared. Patients were followed until the occurrence of any study outcome, death, or up to two years. RESULTS A total of 1 470 patients were identified, with 736 in the dual antithrombotic therapy group and 734 in the DOAC monotherapy group. Among them, 1 346 patients received endovascular therapy as the index revascularisation procedure and 124 underwent bypass surgery. At two years, dual antithrombotic therapy was associated with a higher risk of MALEs than DOAC monotherapy (subdistribution hazard ratio [SHR] 1.34, 95% confidence interval [CI] 1.15 - 1.56), primarily driven by increased repeat revascularisation. Dual antithrombotic therapy was also associated with a higher risk of major bleeding (SHR 1.43, 95% CI 1.05 - 1.94) and gastrointestinal bleeding (SHR 2.17, 95% CI 1.42 - 3.33) than DOAC monotherapy. CONCLUSION In patients with concomitant LEAD and AF who underwent peripheral revascularisation, DOAC monotherapy was associated with a lower risk of MALEs and bleeding events than dual antithrombotic therapy.
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Affiliation(s)
- Donna Shu-Han Lin
- Division of Cardiology, Department of Internal Medicine, Shin Kong Wu Ho-Su Memorial Hospital, Taipei, Taiwan; Division of Cardiology, Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan
| | - Hsu-Ping Wu
- Division of Cardiology, Department of Internal Medicine, Mackay Memorial Hospital Hsinchu Branch, Hsinchu, Taiwan
| | - Wen-Jung Chung
- Division of Cardiology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan; College of Medicine, Chang Gung University, Taoyuan, Taiwan
| | - Shu-Kai Hsueh
- Division of Cardiology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan; College of Medicine, Chang Gung University, Taoyuan, Taiwan
| | - Po-Chao Hsu
- Division of Cardiology, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan; Faculty of Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan
| | - Jen-Kuang Lee
- Division of Cardiology, Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan; Department of Internal Medicine, National Taiwan University College of Medicine, Taipei, Taiwan; Department of Laboratory Medicine, National Taiwan University College of Medicine, Taipei, Taiwan; Cardiovascular Centre, National Taiwan University Hospital, Taipei, Taiwan; Telehealth Centre, National Taiwan University Hospital, Taipei, Taiwan.
| | - Chun-Chi Chen
- College of Medicine, Chang Gung University, Taoyuan, Taiwan; Division of Cardiology, Department of Internal Medicine, Chang Gung Memorial Hospital, Taoyuan, Taiwan
| | - Hsuan-Li Huang
- Division of Cardiology, Department of Internal Medicine, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, New Taipei, Taiwan; School of Post-Baccalaureate Chinese Medicine, Tzu Chi University, Hualien, Taiwan
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19
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Mandieka E, Ohiomoba R, Sobieszczyk P, Eisenhauer AC, Todoran T, Kinlay S. Long-Term Adverse Limb Events After Femoral Artery Endovascular Revascularization: The Boston FAROUT Study. JOURNAL OF THE SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY & INTERVENTIONS 2024; 3:102241. [PMID: 39525994 PMCID: PMC11549512 DOI: 10.1016/j.jscai.2024.102241] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Figures] [Subscribe] [Scholar Register] [Received: 04/24/2024] [Revised: 07/04/2024] [Accepted: 07/09/2024] [Indexed: 11/16/2024]
Abstract
Background : Patient, lesion, and procedural characteristics may impact the long-term risks of adverse limb outcomes differently after successful endovascular revascularization for lower extremity peripheral artery disease. The study objective was to assess the relationships of patient, lesion, and procedural characteristics to the subsequent risk of major and minor adverse limb events over the decade after successful endovascular revascularization of the superficial femoral artery for chronic limb-threatening ischemia (CLTI) or lifestyle-limiting claudication. Methods A retrospective cohort of patients who underwent endovascular revascularization between 2003-2011 were followed for a median of 9.3 (IQR, 6.8-11.1) years. Hazard ratios (HR) and 95% CI from Cox proportional hazards models assessed the risk of major adverse limb events (MALE) (major amputation, bypass, or thrombolysis) or minor revascularization, MALE alone, and minor revascularization alone. Results There were 232 index limb revascularizations in 185 patients. Longer lesion length was associated with a higher risk of MALE or minor revascularization (HR, 2.09; 95% CI, 1.22-3.60) and minor revascularization alone (HR, 2.53; 95% CI, 1.39-4.61). Current smoking was linked with minor revascularization (HR, 3.83; 95% CI, 1.54-9.56). CLTI was associated with MALE or minor revascularization (HR, 1.89; 95% CI, 1.09-3.29), and MALE alone (HR, 7.43; 95% CI, 3.11-17.79). Black race/ethnicity (HR, 4.74; 95% CI, 1.51-14.9) and low-density lipoprotein >100 mg/dL (HR, 2.76; 95% CI, 1.20-6.35) were linked to MALE alone. Conclusions Factors related to MALE differed from those related to minor revascularization. Lesion length and smoking were linked to minor revascularization, whereas CLTI, Black race/ethnicity, and elevated low-density lipoprotein were linked to MALE.
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Affiliation(s)
- Edwin Mandieka
- Brigham and Women’s Hospital, Boston, Massachusetts
- Harvard Medical School, Boston, Massachusetts
| | - Ramael Ohiomoba
- Brigham and Women’s Hospital, Boston, Massachusetts
- Harvard Medical School, Boston, Massachusetts
| | - Piotr Sobieszczyk
- Brigham and Women’s Hospital, Boston, Massachusetts
- Harvard Medical School, Boston, Massachusetts
| | | | - Thomas Todoran
- Medical University of South Carolina, Charleston, South Carolina
- Ralph H. Johnson Veterans Affairs Medical Center, Charleston, South Carolina
| | - Scott Kinlay
- Brigham and Women’s Hospital, Boston, Massachusetts
- Harvard Medical School, Boston, Massachusetts
- VA Boston Healthcare System, Boston, Massachusetts
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20
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MacLean EA, Fogarty EJ, Peterson BJ, Xu S, Giacomantonio NB. Peripheral Arterial Disease in Nova Scotia: Increased Prevalence, Low Public Awareness, and Poor Edinburgh Claudication Questionnaire Sensitivity. CJC Open 2024; 6:1210-1219. [PMID: 39525342 PMCID: PMC11544288 DOI: 10.1016/j.cjco.2024.07.003] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/01/2024] [Accepted: 07/10/2024] [Indexed: 11/16/2024] Open
Abstract
Background This study had the following 3 goals: (i) to assess the prevalence of peripheral arterial disease (PAD) in a Nova Scotian population; (ii) to evaluate the validity of the Edinburgh Claudication Questionnaire (ECQ) in a Nova Scotian context; and (iii) to evaluate Nova Scotian public knowledge about PAD. Methods Participants were recruited from 8 sites across Nova Scotia. In 2022, they were recruited at Heartland Tour (HLT) sites-a provincial health-promotion campaign. In 2023, they were recruited in communities coinciding with HLT sites (public [PUB]). Participants completed a demographics questionnaire, ECQ, and had an ankle-brachial index (ABI) measurement. An ABI of < 0.9 was considered positive for presence of PAD. Results A total of 417 participants were recruited, 263 from HLT, and 154 from PUB. A total of 398 participants had ABI scores resulting in a PAD prevalence of 2.81% (249 participants) in the HLT group, and 5.37% (149 participants) in the PUB group. A total of 394 participants had both ABI and ECQ scores, with a found sensitivity of 6.67% (confidence interval 0.17%-31.95%) and specificity of 97.63% (confidence interval 95.54%-98.91%). A total of 75% of participants (311 of 417) did not have prior knowledge of PAD. Conclusions The PAD prevalences in both cohorts were higher than anticipated, with the PUB cohort being more than double the national average. This finding raises the following question: should specific PAD primary and/or secondary prevention strategies be targeted within the province? Our study demonstrated that a public-awareness campaign would be highly impactful, owing to a low level of awareness of PAD within both cohorts, and that the ECQ was not an effective screening tool when used on the Nova Scotian population.
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Affiliation(s)
- Emma Alicia MacLean
- MD Candidate, Department of Medicine, Dalhousie University, Halifax, Nova Scotia, Canada
- Department of Science, Dalhousie University, Halifax, Nova Scotia, Canada
- Department of Nursing, University of Prince Edward Island, Charlottetown, Prince Edward Island, Canada
| | - Ethan Joel Fogarty
- MD Candidate, Department of Medicine, Dalhousie University, Halifax, Nova Scotia, Canada
- Department of Science, Dalhousie University, Halifax, Nova Scotia, Canada
| | - Benjamin James Peterson
- MD Candidate, Department of Medicine, Dalhousie University, Halifax, Nova Scotia, Canada
- Department of Arts and Social Sciences, Carleton University, Ottawa, Ontario, Canada
- Department of Fine Arts, Concordia University, Montreal, Quebec, Canada
| | - Shirley Xu
- MD Candidate, Department of Medicine, Dalhousie University, Halifax, Nova Scotia, Canada
- Department of Science, University of Toronto, Toronto, Ontario, Canada
| | - Nicholas Blair Giacomantonio
- Department of Medicine, Memorial University, St. John’s, Newfoundland, Canada
- Division of Cardiology, Department of Medicine, Dalhousie University, Halifax, Nova Scotia, Canada
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21
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Hart O, Lee KT, Gormley S, August B, Abbott G, Khashram M. Editor's Choice - Association of Pedal Acceleration Time With Healing and Amputation Free Survival in Patients With Ulceration and Gangrene. Eur J Vasc Endovasc Surg 2024; 68:490-497. [PMID: 38825036 DOI: 10.1016/j.ejvs.2024.05.043] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/10/2023] [Revised: 05/05/2024] [Accepted: 05/30/2024] [Indexed: 06/04/2024]
Abstract
OBJECTIVE Pedal acceleration time (PAT) is a novel non-invasive perfusion measurement that may be useful in the management of patients with ulceration and gangrene. The objective of this study was to report the association between PAT and wound healing, amputation free survival (AFS), and mortality at one year. METHODS This prospective observational study reviewed all patients who underwent PAT after presentation with ulceration or gangrene from 1 January 2020 to 30 June 2022. PAT was defined as the time (in milliseconds) from the onset of systole to the peak of systole in the mid artery. The final PAT of a limb was used to assess outcomes (presenting PAT if no revascularisation, or post-revascularisation PAT). Wound healing, major limb amputation, and death at one year were collected. Healing was assessed with Fine-Gray competing risks model, AFS via logistic regression, and survival using Cox proportional hazards model. RESULTS Overall, 265 patients (307 limbs) were included. The median patient age was 71 years and 74.0% (196/265) had diabetes mellitus. Patient demographics were similar among the final PAT category cohorts. Compared with a final PAT category 1, analysis of one year outcomes showed that the final PAT categories 2 - 4 had lower wound healing (category 2, hazard ratio [HR] 0.62, 95% confidence interval [CI] 0.43 - 0.9, p = .012; category 3, HR 0.21, 95% CI 0.08 - 0.58, p = .002; category 4, HR 0.12, 95% CI 0.04 - 0.34, p < .001), lower AFS (category 2, odds ratio [OR] 2.86, 95% CI 1.64 - 5.0, p < .001; category 3, OR 5.1, 95% CI 1.71 - 15.22, p = .003; category 4, OR 12.59, 95% CI 4.34 - 36.56, p < .001), and lower survival (category 2, HR 1.89, 95% CI 1.17 - 3.03, p =.009; category 3, HR 2.37, 95% CI 1.05 - 5.36, p = .039; category 4, HR 4.52, 95% CI 2.48 - 8.21, p < .001). CONCLUSION The final PAT measurement is associated with wound healing, AFS, and death at one year. PAT may be a valuable tool to assess perfusion of the foot.
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Affiliation(s)
- Odette Hart
- Department of Surgery, The University of Auckland, Auckland, New Zealand; Department of Vascular and Endovascular Surgery, Waikato Hospital, Hamilton, New Zealand.
| | - Khai Tuck Lee
- Department of Surgery, The University of Auckland, Auckland, New Zealand
| | - Sinead Gormley
- Department of Surgery, The University of Auckland, Auckland, New Zealand; Department of Vascular and Endovascular Surgery, Waikato Hospital, Hamilton, New Zealand
| | - Bridget August
- Department of Vascular and Endovascular Surgery, Waikato Hospital, Hamilton, New Zealand
| | - Grant Abbott
- Department of Vascular and Endovascular Surgery, Waikato Hospital, Hamilton, New Zealand
| | - Manar Khashram
- Department of Surgery, The University of Auckland, Auckland, New Zealand; Department of Vascular and Endovascular Surgery, Waikato Hospital, Hamilton, New Zealand
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Mazzolai L, Teixido-Tura G, Lanzi S, Boc V, Bossone E, Brodmann M, Bura-Rivière A, De Backer J, Deglise S, Della Corte A, Heiss C, Kałużna-Oleksy M, Kurpas D, McEniery CM, Mirault T, Pasquet AA, Pitcher A, Schaubroeck HAI, Schlager O, Sirnes PA, Sprynger MG, Stabile E, Steinbach F, Thielmann M, van Kimmenade RRJ, Venermo M, Rodriguez-Palomares JF. 2024 ESC Guidelines for the management of peripheral arterial and aortic diseases. Eur Heart J 2024; 45:3538-3700. [PMID: 39210722 DOI: 10.1093/eurheartj/ehae179] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 09/04/2024] Open
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Wischmann P, Stern M, Florea DI, Neudorf L, Haddad Y, Kramser N, Schillings M, Baasen S, Schremmer J, Heiss C, Kelm M, Busch L. Three-Year Safety and Efficacy of Endovascular Treatment of Common Femoral Artery in 150 PAD Patients. Biomedicines 2024; 12:2213. [PMID: 39457526 PMCID: PMC11505484 DOI: 10.3390/biomedicines12102213] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/30/2024] [Revised: 09/21/2024] [Accepted: 09/26/2024] [Indexed: 10/28/2024] Open
Abstract
Background: The gold standard treatment for peripheral arterial disease (PAD) of the common femoral artery (CFA) is open common femoral endarterectomy (CFAE). Interest in the less invasive endovascular treatment (EVT) is growing due to PAD patients' frequent co-morbidities. Aims: We aimed to evaluate three-year EVT outcomes in multimorbid PAD patients with severe calcified CFA lesions. Methods: Using the prospectively maintained "all-comers" Duesseldorf PTA Registry, we analysed the three-year outcomes of 150 patients with EVT of the CFA. Between January 2017 and October 2023, 66 patients received a rotational excisional atherectomy (REA) followed by a drug-coated balloon angioplasty (DCB), and 84 patients received a DCB alone. Results: All procedures involved the CFA, 49% additionally involved the proximal superficial femoral artery (SFA), and 10% of the lesions involved the profunda femoris artery (PFA). The procedural success rate was 97% and independent of PAD stage, with a higher level of stent implantation in the DCB group (58% vs. 39%, p < 0.05). The primary patency rate at one year was 83% for REA + DCB and 87% for DCB (p = 0.576), while secondary patency after three years was 97%. The MALE rate at three years was mainly driven by cdTLR (REA + DCB: (20%) vs. DCB: (14%), p = 0.377), while major amputations were low in both groups (REA + DCB: 3% vs. DCB: 1%). Overall, the major adverse cardiovascular events (MACEs) rate at three years was low (REA + DCB: (5%) vs. DCB: (11%), p = 0.170). Conclusions: The EVT of severely calcified CFA lesions is safe and effective, with high three-year patency rates and low rates of major adverse limb events (MALEs) and MACEs. This registry demonstrates that vessel preparation with REA minimizes the need for stenting.
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Affiliation(s)
- Patricia Wischmann
- Division of Cardiology, Pulmonology and Vascular Medicine, Medical Faculty, Heinrich Heine University of Duesseldorf, Moorenstr. 5, 40225 Düsseldorf, Germany; (M.S.); (D.-I.F.); (L.N.); (Y.H.); (N.K.); (M.S.); (S.B.); (M.K.); (L.B.)
- CARID—Cardiovascular Research Institute Düsseldorf, Medical Faculty, University Hospital Düsseldorf, Heinrich-Heine-University Düsseldorf, 40225 Düsseldorf, Germany
| | - Manuel Stern
- Division of Cardiology, Pulmonology and Vascular Medicine, Medical Faculty, Heinrich Heine University of Duesseldorf, Moorenstr. 5, 40225 Düsseldorf, Germany; (M.S.); (D.-I.F.); (L.N.); (Y.H.); (N.K.); (M.S.); (S.B.); (M.K.); (L.B.)
| | - David-Ioan Florea
- Division of Cardiology, Pulmonology and Vascular Medicine, Medical Faculty, Heinrich Heine University of Duesseldorf, Moorenstr. 5, 40225 Düsseldorf, Germany; (M.S.); (D.-I.F.); (L.N.); (Y.H.); (N.K.); (M.S.); (S.B.); (M.K.); (L.B.)
| | - Luise Neudorf
- Division of Cardiology, Pulmonology and Vascular Medicine, Medical Faculty, Heinrich Heine University of Duesseldorf, Moorenstr. 5, 40225 Düsseldorf, Germany; (M.S.); (D.-I.F.); (L.N.); (Y.H.); (N.K.); (M.S.); (S.B.); (M.K.); (L.B.)
| | - Yassine Haddad
- Division of Cardiology, Pulmonology and Vascular Medicine, Medical Faculty, Heinrich Heine University of Duesseldorf, Moorenstr. 5, 40225 Düsseldorf, Germany; (M.S.); (D.-I.F.); (L.N.); (Y.H.); (N.K.); (M.S.); (S.B.); (M.K.); (L.B.)
| | - Nicolas Kramser
- Division of Cardiology, Pulmonology and Vascular Medicine, Medical Faculty, Heinrich Heine University of Duesseldorf, Moorenstr. 5, 40225 Düsseldorf, Germany; (M.S.); (D.-I.F.); (L.N.); (Y.H.); (N.K.); (M.S.); (S.B.); (M.K.); (L.B.)
| | - Miriam Schillings
- Division of Cardiology, Pulmonology and Vascular Medicine, Medical Faculty, Heinrich Heine University of Duesseldorf, Moorenstr. 5, 40225 Düsseldorf, Germany; (M.S.); (D.-I.F.); (L.N.); (Y.H.); (N.K.); (M.S.); (S.B.); (M.K.); (L.B.)
| | - Sven Baasen
- Division of Cardiology, Pulmonology and Vascular Medicine, Medical Faculty, Heinrich Heine University of Duesseldorf, Moorenstr. 5, 40225 Düsseldorf, Germany; (M.S.); (D.-I.F.); (L.N.); (Y.H.); (N.K.); (M.S.); (S.B.); (M.K.); (L.B.)
| | - Johanna Schremmer
- Division of Cardiology, Pulmonology and Vascular Medicine, Medical Faculty, Heinrich Heine University of Duesseldorf, Moorenstr. 5, 40225 Düsseldorf, Germany; (M.S.); (D.-I.F.); (L.N.); (Y.H.); (N.K.); (M.S.); (S.B.); (M.K.); (L.B.)
| | - Christian Heiss
- Department of Clinical and Experimental Medicine, Faculty of Health and Medical Sciences, University of Surrey, Guildford GU2 7YH, UK;
- Department of Vascular Medicine, Surrey and Sussex NHS Healthcare Trust, Redhill RH1 5RH, UK
| | - Malte Kelm
- Division of Cardiology, Pulmonology and Vascular Medicine, Medical Faculty, Heinrich Heine University of Duesseldorf, Moorenstr. 5, 40225 Düsseldorf, Germany; (M.S.); (D.-I.F.); (L.N.); (Y.H.); (N.K.); (M.S.); (S.B.); (M.K.); (L.B.)
- CARID—Cardiovascular Research Institute Düsseldorf, Medical Faculty, University Hospital Düsseldorf, Heinrich-Heine-University Düsseldorf, 40225 Düsseldorf, Germany
| | - Lucas Busch
- Division of Cardiology, Pulmonology and Vascular Medicine, Medical Faculty, Heinrich Heine University of Duesseldorf, Moorenstr. 5, 40225 Düsseldorf, Germany; (M.S.); (D.-I.F.); (L.N.); (Y.H.); (N.K.); (M.S.); (S.B.); (M.K.); (L.B.)
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24
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Bonaca MP, Barnes GD, Bauersachs R, Bessada Y, Conte MS, Dua A, Hess CN, Serhal M, Mena-Hurtado C, Weitz JI, Beckman JA. Antithrombotic Strategies for Patients With Peripheral Artery Disease: JACC Scientific Statement. J Am Coll Cardiol 2024; 84:936-952. [PMID: 39197984 DOI: 10.1016/j.jacc.2024.06.027] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/26/2024] [Revised: 06/06/2024] [Accepted: 06/21/2024] [Indexed: 09/01/2024]
Abstract
Patients with peripheral artery disease (PAD) experience major cardiovascular and limb events. Antithrombotic strategies including antiplatelets and anticoagulants remain a cornerstone of treatment and prevention. Recent trials have shown heterogeneity in the response to antithrombotic therapies in patients presenting primarily with PAD when compared to those presenting primarily with coronary artery disease. In addition, there is observed heterogeneity with regards to the effects of antiplatelets and anticoagulants with respect to different outcomes including cardiovascular and major adverse limb events. This, coupled with risks of bleeding, requires a patient-centered and holistic assessment of benefit-risk when selecting antithrombotic strategies for patients with PAD. A global multidisciplinary work group was convened to evaluate antithrombotic strategies in PAD and to summarize the current state of the art. Common clinical scenarios around antithrombotic decision making were provided. Finally, insights with regard to implementation future investigation were described.
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Affiliation(s)
- Marc P Bonaca
- CPC Clinical Research, Department of Medicine, Division of Cardiology, University of Colorado School of Medicine, Aurora, Colorado, USA.
| | - Geoffrey D Barnes
- Frankel Cardiovascular Center, Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan, USA
| | - Rupert Bauersachs
- Cardioangiology Center Bethanien, Frankfurt, Germany, and the Center for Vascular Research, Munich, Germany
| | - Youssef Bessada
- University of Connecticut School of Pharmacy, Storrs, Connecticut, USA
| | - Michael S Conte
- Vascular Surgery and Center for Limb Preservation, University of California-San Francisco, San Francisco, California, USA
| | - Anahita Dua
- Division of Vascular and Endovascular Surgery, Department of Surgery, Massachusetts General Hospital/Harvard Medical School, Boston, Massachusetts, USA
| | - Connie N Hess
- CPC Clinical Research, Department of Medicine, Division of Cardiology, University of Colorado School of Medicine, Aurora, Colorado, USA
| | - Maya Serhal
- Cardiovascular Division, Massachusetts General Hospital/Harvard Medical School, Boston, Massachusetts, USA
| | - Carlos Mena-Hurtado
- Vascular Medicine Outcomes (VAMOS) Program, Department of Internal Medicine, Section of Cardiology, Yale University, New Haven, Connecticut, USA
| | - Jeffrey I Weitz
- McMaster University and the Thrombosis and Atherosclerosis Research Institute, Hamilton, Ontario, Canada
| | - Joshua A Beckman
- Vascular Medicine, UT Southwestern Medical Center, Dallas, Texas, USA
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25
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Yu AX, Ding JB, Davies AH, Shan LL. A Scoping Review of Decision Support Tools for Patients with Lower Extremity Arterial Disease: Toward Shared Decision-Making. Ann Vasc Surg 2024; 106:25-36. [PMID: 38599480 DOI: 10.1016/j.avsg.2024.02.014] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/02/2023] [Revised: 01/31/2024] [Accepted: 02/07/2024] [Indexed: 04/12/2024]
Abstract
BACKGROUND In recent years, decision support tools (DSTs) in various fields of medicine have emerged to aid clinicians and patients in the process of shared decision-making (SDM). This scoping review aims to identify the existing DSTs for selecting treatments in lower extremity arterial disease and to evaluate their effectiveness in facilitating SDM. METHODS The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines for scoping reviews were followed. A literature search was conducted across MEDLINE, EMBASE, and Cochrane databases, along with the Decision Aid Library Inventory, for studies published between January 2000 and June 2023. Articles reporting the development and/or clinical application of a DST specific to lower extremity arterial disease were included. A narrative synthesis of the results was performed and findings were presented in tabular formats. RESULTS Five studies and 5 unique DSTs were included. Presenting formats included websites, booklets, brochures, and pocket cards. Overall, a high degree of heterogeneity was observed across all DSTs in their format, content, and delivery. A widespread acceptability and satisfaction were reported among patients and clinicians. However, their effect at improving SDM remains uncertain due to the lack of standardized outcome metrics. CONCLUSIONS The development and implementation of DSTs for lower limb arterial disease treatment discussion remain in the early stages. This review lays the foundation for future studies to continue exploring optimal strategies for DST development and their role in supporting SDM.
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Affiliation(s)
- Annie X Yu
- Melbourne Medical School, The University of Melbourne, Parkville, Victoria, Australia
| | - Joel B Ding
- Department of Vascular Surgery, St. Vincent's Hospital Melbourne, Fitzroy, Melbourne, Australia.
| | - Alun H Davies
- Faculty of Medicine, Department of Surgery and Cancer, Imperial College London, London, UK
| | - Leonard L Shan
- Department of Vascular Surgery, St. Vincent's Hospital Melbourne, Fitzroy, Melbourne, Australia; Faculty of Medicine, Dentistry and Health Sciences, Department of Surgery, The University of Melbourne, Parkville, Australia
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26
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Porras CP, de Boer AR, Koop Y, Vaartjes I, Teraa M, Hazenberg CEVB, Verhaar MC, Vernooij RWM. Sex Differences in Mortality Risk after the First Hospitalisation with Lower Extremity Peripheral Arterial Disease. Eur J Vasc Endovasc Surg 2024; 68:378-384. [PMID: 38697256 DOI: 10.1016/j.ejvs.2024.04.039] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/04/2023] [Revised: 03/22/2024] [Accepted: 04/25/2024] [Indexed: 05/04/2024]
Abstract
OBJECTIVE Lower extremity peripheral arterial disease (PAD) is a severe condition that increases the risk of major adverse cardiovascular events, major adverse limb events, and all cause mortality. This study aimed to investigate the mortality risk among females and males hospitalised for the first time with lower extremity PAD. METHODS Three cohorts of patients who were admitted for the first time with lower extremity PAD in 2007 - 2010, 2011 - 2014, and 2015 - 2018 were constructed. For the 2007 - 2010 and 2011 - 2014 cohorts, the 28 day, one year, and five year mortality rates were calculated, assessing survival time from date of hospital admission until date of death, end of study period, or censoring. For the 2015 - 2018 cohort, only 28 day and one year mortality were investigated due to lack of follow up data. Mortality rates of these cohorts were compared with the general population using standardised mortality rates (SMRs), and the risk of death between sexes was evaluated using Cox proportional hazards models. Cox models were adjusted for age, cardiovascular disease, and diabetes mellitus to account for potential confounding factors. RESULTS In total, 7 950, 9 670, and 13 522 patients were included in the 2007 - 2010, 2011 - 2014, and 2015 - 2018 cohorts, respectively. Over 60% of individuals in each cohort were males. Mortality rates at 28 day and one year remained stable across all cohorts, while the five year mortality rate increased for both males and females in the 2011 - 2014 cohort. The SMRs both of females and males with PAD were significantly higher than in the general population. Multivariable regression analyses found no significant differences in mortality risk between sexes at 28 day and one year. However, the five year mortality risk was lower in females, with a hazard ratio of 0.89 (95% confidence interval [CI] 0.83 - 0.97) in the 2007 - 2010 cohort and 0.88 (95% CI 0.82 - 0.94) in the 2011 - 2014 cohort. CONCLUSION The five year mortality risk has increased, and females face a lower mortality risk than males. Lower extremity PAD still carries unfavourable long term consequences compared with the general population.
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Affiliation(s)
- Cindy P Porras
- Department of Nephrology and Hypertension, University Medical Centre Utrecht, Utrecht, the Netherlands; Julius Centre for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht, the Netherlands
| | - Annemarijn R de Boer
- Julius Centre for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht, the Netherlands
| | - Yvonne Koop
- Julius Centre for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht, the Netherlands
| | - Ilonca Vaartjes
- Julius Centre for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht, the Netherlands
| | - Martin Teraa
- Department of Vascular Surgery, University Medical Centre Utrecht, Utrecht, the Netherlands
| | | | - Marianne C Verhaar
- Department of Nephrology and Hypertension, University Medical Centre Utrecht, Utrecht, the Netherlands
| | - Robin W M Vernooij
- Department of Nephrology and Hypertension, University Medical Centre Utrecht, Utrecht, the Netherlands; Julius Centre for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht, the Netherlands.
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27
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Porras CP, Teraa M, Damen JAA, Hazenberg CEVB, Bots ML, Verhaar MC, Vernooij RWM. Editor's Choice - Prognostic Factors and Models to Predict Mortality Outcomes in Patients with Peripheral Arterial Disease: A Systematic Review. Eur J Vasc Endovasc Surg 2024; 68:361-377. [PMID: 38795905 DOI: 10.1016/j.ejvs.2024.05.029] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/09/2023] [Revised: 04/18/2024] [Accepted: 05/14/2024] [Indexed: 05/28/2024]
Abstract
OBJECTIVE Predicting adverse outcomes in patients with peripheral arterial disease (PAD) is a complex task owing to the heterogeneity in patient and disease characteristics. This systematic review aimed to identify prognostic factors and prognostic models to predict mortality outcomes in patients with PAD Fontaine stage I - III or Rutherford category 0 - 4. DATA SOURCES PubMed, Embase, and Cochrane Database of Systematic Reviews were searched to identify studies examining individual prognostic factors or studies aiming to develop or validate a prognostic model for mortality outcomes in patients with PAD. REVIEW METHODS Information on study design, patient population, prognostic factors, and prognostic model characteristics was extracted, and risk of bias was evaluated. RESULTS Sixty nine studies investigated prognostic factors for mortality outcomes in PAD. Over 80 single prognostic factors were identified, with age as a predictor of death in most of the studies. Other common factors included sex, diabetes, and smoking status. Six studies had low risk of bias in all domains, and the remainder had an unclear or high risk of bias in at least one domain. Eight studies developed or validated a prognostic model. All models included age in their primary model, but not sex. All studies had similar discrimination levels of > 70%. Five of the studies on prognostic models had an overall high risk of bias, whereas two studies had an overall unclear risk of bias. CONCLUSION This systematic review shows that a large number of prognostic studies have been published, with heterogeneity in patient populations, outcomes, and risk of bias. Factors such as sex, age, diabetes, hypertension, and smoking are significant in predicting mortality risk among patients with PAD Fontaine stage I - III or Rutherford category 0 - 4.
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Affiliation(s)
- Cindy P Porras
- Department of Nephrology and Hypertension, University Medical Centre Utrecht, Utrecht, The Netherlands; Julius Centre for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht University, Utrecht, The Netherlands
| | - Martin Teraa
- Department of Vascular Surgery, University Medical Centre Utrecht, Utrecht, The Netherlands
| | - Johanna A A Damen
- Julius Centre for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht University, Utrecht, The Netherlands
| | | | - Michiel L Bots
- Julius Centre for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht University, Utrecht, The Netherlands
| | - Marianne C Verhaar
- Department of Nephrology and Hypertension, University Medical Centre Utrecht, Utrecht, The Netherlands
| | - Robin W M Vernooij
- Department of Nephrology and Hypertension, University Medical Centre Utrecht, Utrecht, The Netherlands; Julius Centre for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht University, Utrecht, The Netherlands.
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28
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Ahmed A, Hamed M, Abozaid A, Elkheshen A, Fisher M, Khalife W, Jneid H, Banerjee S, Elbadawi A. Use of Direct Oral Anticoagulants in Patients With Peripheral Artery Disease: A Meta-Analysis. Am J Cardiol 2024; 226:34-35. [PMID: 38968978 DOI: 10.1016/j.amjcard.2024.06.031] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/04/2024] [Accepted: 06/28/2024] [Indexed: 07/07/2024]
Affiliation(s)
- Asmaa Ahmed
- Department of Internal Medicine, Rochester General Hospital, Rochester, New York
| | - Mohamed Hamed
- Division of Cardiology, Florida Atlantic University, Boca Raton, Florida
| | - Ahmed Abozaid
- Division of Cardiology, Ain Shams University, Cairo, Egypt
| | - Ahmed Elkheshen
- Department of Internal Medicine, Texas Tech University Health, Lubbock, Texas
| | - Mark Fisher
- Division of Cardiology, Florida Atlantic University, Boca Raton, Florida
| | - Wissam Khalife
- Division of Cardiology, University of Texas Medical Branch, Galveston, Texas
| | - Hani Jneid
- Division of Cardiology, University of Texas Medical Branch, Galveston, Texas
| | | | - Ayman Elbadawi
- Division of Cardiology, Christus Good Shepherd Medical Center, Longview, Texas; Texas A&M School of Medicine, Bryan, Texas
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29
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Cheun TJ, Hart JP, Davies MG. Pedal medial arterial calcification influences the outcomes of isolated infra-malleolar interventions for chronic limb-threatening ischemia. J Vasc Surg 2024; 80:800-810.e1. [PMID: 38649103 DOI: 10.1016/j.jvs.2024.04.042] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/29/2024] [Revised: 04/05/2024] [Accepted: 04/12/2024] [Indexed: 04/25/2024]
Abstract
OBJECTIVE Inframalleolar disease is present in most diabetic patients presenting with tissue loss. Inframalleolar (pedal) artery disease and pedal medial arterial calcification (pMAC) are associated with major amputation in patients with chronic limb-threatening ischemia (CLTI). This study aimed to examine the impact of pMAC on the outcomes after isolated inframalleolar (pedal artery) interventions. METHODS A database of lower extremity endovascular intervention for patients with tissue loss between 2007 and 2022 was retrospectively queried. Patients with CLTI were selected, and those undergoing isolated inframalleolar intervention on the dorsalis pedis and medial and lateral tarsal arteries and who had foot x-rays were identified. X-rays were assessed blindly for pMAC and scored on a scale of 0 to 5. Patients with concomitant superficial femoral artery and tibial interventions were excluded. Intention to treat analysis by the patient was performed. Amputation-free survival (survival without major amputation) was evaluated. RESULTS A total of 223 patients (51% female; 87% Hispanic; average age, 66 years; 323 vessels) underwent isolated infra-malleolar intervention for tissue loss. All patients had diabetes, 96% had hypertension, 79% had hyperlipidemia, and 63% had chronic renal insufficiency (55% of these were on hemodialysis). Most of the patients had Wound, Ischemia, and foot Infection (WIfI) stage 3 disease and had various stages of pMAC: severe (score = 5) in 48%, moderate (score = 2-4) in 31%, and mild (score = 0-1) in 21% of the patients. Technical success was 94%, with a median of one vessel treated per patient. All failures were in severe pMAC. Overall, major adverse cardiovascular events was 0.9% at 90 days after the procedure. Following the intervention, most patients underwent a planned forefoot amputation (single digit, multiple digits, ray amputation, or trans-metatarsal amputation). WIfI ischemic grade was improved by 51%. Wound healing at 3 months was 69%. Those not healing underwent below-knee amputations. The overall 5-year amputation-free survival rate was 35% ± 9%. The severity of pMAC was associated with decreased AFS. CONCLUSIONS Increasing severity of pMAC influences the technical and long-term outcomes of infra-malleolar intervention in diabetes. Severe pMAC is associated with amputation and should be considered as a variable in the shared decision-making of diabetic patients with CLTI.
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Affiliation(s)
- Tracy J Cheun
- Center for Quality, Effectiveness, and Outcomes in Cardiovascular Diseases, Houston, TX; Department of Anesthesia, Long School of Medicine, San Antonio, TX
| | - Joseph P Hart
- Center for Quality, Effectiveness, and Outcomes in Cardiovascular Diseases, Houston, TX; Division of Vascular and Endovascular Surgery, Medical College of Wisconsin, Milwaukee, WI
| | - Mark G Davies
- Center for Quality, Effectiveness, and Outcomes in Cardiovascular Diseases, Houston, TX; Department of Vascular and Endovascular Surgery, Ascension Health, Waco, TX.
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30
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Altin SE, Parise H, Hess CN, Rosenthal NA, Julien HM, Curtis JP. Co-Morbidity Differences Associated With Long-Term Amputation and Repeat Revascularization Rates After Femoropopliteal Artery Intervention for Intermittent Claudication by Sex, Race, and Ethnicity. Am J Cardiol 2024; 226:40-49. [PMID: 38834142 DOI: 10.1016/j.amjcard.2024.05.021] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/15/2024] [Revised: 04/29/2024] [Accepted: 05/11/2024] [Indexed: 06/06/2024]
Abstract
Use of peripheral vascular intervention (PVI) for intermittent claudication (IC) continues to expand, but there is uncertainty whether baseline demographics, procedural techniques and outcomes differ by sex, race, and ethnicity. This study aimed to examine amputation and revascularization rates up to 4 years after femoropopliteal (FP) PVI for IC by sex, race, and ethnicity. Patients who underwent FP PVI for IC between 2016 and 2020 from the PINC AI Healthcare Database were analyzed. The primary outcome was any index limb amputation, assessed by Kaplan-Meier estimate. Secondary outcomes included index limb major amputation, repeat revascularization, and index limb repeat revascularization. Unadjusted and adjusted hazard ratios (HRs) were estimated using Cox proportional hazard regression models. This study included 19,324 patients with IC who underwent FP PVI, with 41.2% women, 15.6% Black patients, and 4.7% Hispanic patients. Women were less likely than men to be treated with atherectomy (45.1% vs 47.8%, p = 0.0003); Black patients were more likely than White patients to receive atherectomy (50.7% vs 44.9%, p <0.001), and Hispanic patients were less likely than non-Hispanic patients to receive atherectomy (41% vs 47%, p = 0.0004). Unadjusted rates of any amputation were similar in men and women (6.4% for each group, log-rank p = 0.842), higher in Black patients than in White patients (7.8% vs 6.1%, log-rank p = 0.007), and higher in Hispanic patients than in non-Hispanic patients (8.8% vs 6.3%, log-rank p = 0.031). After adjustment for baseline characteristics, Black race was associated with higher rates of repeat revascularization (adjusted HR 1.13, 95% confidence interval 1.04 to 1.22) and any FP revascularization (adjusted HR 1.10, 95% confidence interval 1.01 to 1.20). No statistical difference in amputation rate was observed among comparison groups. Women and men with IC had similar crude and adjusted amputation and revascularization outcomes after FP PVI. Black patients had higher repeat revascularization and any FP revascularization rates than did White patients. Black and Hispanic patients had higher crude amputation rates, but these differences were attenuated by adjustment for baseline characteristics. Black patients were more likely to receive atherectomy and had higher rates of any repeat revascularization and specifically FP revascularization. Further study is necessary to determine whether these patterns are related to disease-specific issues or practice-pattern differences among different populations.
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Affiliation(s)
- S Elissa Altin
- Section of Cardiovascular Medicine, Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut; West Haven VA Medical Center, West Haven, Connecticut.
| | - Helen Parise
- Section of Cardiovascular Medicine, Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut
| | - Connie N Hess
- Division of Cardiology, Department of Medicine, University of Colorado School of Medicine, Aurora, Colorado; CPC Clinical Research, Aurora, Colorado
| | - Ning A Rosenthal
- PINC AI Applied Sciences, Premier Inc., Charlotte, North Carolina
| | - Howard M Julien
- Division of Cardiovascular Medicine, University of Pennsylvania, Philadelphia, Pennsylvania; Penn Cardiovascular Outcomes, Quality & Evaluative Research Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania; The Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, Pennsylvania; Center for Health Equity Research and Promotion, Michael J. Crescenz Veterans Affairs Medical Center, Philadelphia, Pennsylvania; Penn Cardiovascular Center for Health Equity and Social Justice, Philadelphia, Pennsylvania
| | - Jeptha P Curtis
- Section of Cardiovascular Medicine, Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut; Center for Outcomes Research and Evaluation, Yale New Haven Hospital, New Haven, Connecticut
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31
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Bourron O, Mohammedi K, De Keizer J, Schneider F, Hadjadj S, Saulnier PJ. A prospective observational study to evaluate a possible relationship between vitamin K antagonist therapy and risk of peripheral arterial disease in patients with type 2 diabetes. Diabetes Obes Metab 2024; 26:3290-3298. [PMID: 38747240 DOI: 10.1111/dom.15656] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/31/2024] [Revised: 04/29/2024] [Accepted: 04/29/2024] [Indexed: 07/10/2024]
Abstract
AIM The use of vitamin K antagonists (VKAs) may increase the risk of peripheral arterial disease (PAD) because vitamin K is a strong inhibitor of medial arterial calcification. Type 2 diabetes (T2D) exposes patients to an increased risk of PAD. We examined how the use of VKAs modulates the risk of incident PAD in people with T2D. MATERIALS AND METHODS SURDIAGENE is a French cohort including 1468 patients with T2D with a prospective follow-up from 2002 to 2015. The primary outcome of the current analysis was the first occurrence of PAD, a composite of lower-limb amputation (LLA) or lower-limb revascularization. LLA and lower-limb revascularization were considered individually as secondary outcomes. RESULTS During a 7-year median follow-up, PAD occurred in 147 (10%) of the 1468 participants. The use of VKAs was not significantly associated with the risk of PAD [multivariable adjusted hazard ratio (HR) 1.42, 95% confidence interval (CI), 0.88-2.31]. During the study period, LLA and lower-limb revascularization occurred in 82 (6%) and 105 (7%) participants, respectively. The use of VKAs was significantly associated with increased risk of LLA [multivariable adjusted HR 1.90 (95% CI, 1.04-3.47)], but not lower-limb revascularization [multivariable adjusted HR 1.08 (95% CI, 0.59-1.97)]. CONCLUSIONS In this prospective study, we did not observe any excess risk of PAD requiring lower-limb revascularization in people with type 2 diabetes using VKAs. However, our data suggest a high risk of LLA in VKA users. Further studies are required to confirm this observation.
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Affiliation(s)
- Olivier Bourron
- Sorbonne Université Médecine, Assistance Publique Hôpitaux de Paris (APHP), Diabetology Department, Pitié-Salpêtrière Hospital, INSERM UMRS_1138, Centre de Recherche des Cordeliers, Institute of Cardiometabolism and Nutrition (ICAN), Paris, France
| | - Kamel Mohammedi
- Hôpital Haut-Lévêque, Department of Endocrinology, Diabetes and Nutrition, University of Bordeaux, Faculty of Medicine, INSERM unit 1034, Biology of Cardiovascular Diseases, Bordeaux University Hospital, Bordeaux, France
| | - Joe De Keizer
- Centre d'Investigation Clinique CIC1402, Université de Poitiers, CHU de Poitiers, INSERM, Poitiers, France
| | - Fabrice Schneider
- Centre d'Investigation Clinique CIC1402, Université de Poitiers, CHU de Poitiers, INSERM, Poitiers, France
| | - Samy Hadjadj
- L'institut du Thorax, INSERM, CNRS, UNIV Nantes, Diabetology Department, CHU Nantes, Nantes, France
| | - Pierre-Jean Saulnier
- Centre d'Investigation Clinique CIC1402, Université de Poitiers, CHU de Poitiers, INSERM, Poitiers, France
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Xiong H, Wang D, Song P, Quan X, Zhang M, Huang S, Liu X, Chen Q, He X, Hu X, Yang X, Shi M. Development and validation of a major adverse limb events prediction model for peripheral arterial disease with frailty. J Vasc Surg 2024; 80:177-187.e2. [PMID: 38458361 DOI: 10.1016/j.jvs.2024.02.036] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/21/2023] [Revised: 02/17/2024] [Accepted: 02/28/2024] [Indexed: 03/10/2024]
Abstract
OBJECTIVE To investigate the risk factors for major limb adverse events (MALE) in peripheral arterial disease (PAD) combined with frailty and to develop and validate a risk prediction model of MALE. METHODS This prospective study was performed in the vascular surgery department of patients in six hospitals in southwest China. Prospective collection of patients with PAD combined with frailty from February 1 to December 20, 2021, with MALE as the primary outcome, and followed for 1 year. The cohort was divided into a development cohort and a validation cohort. In the development cohort, a multivariate risk prediction model was developed to predict MALE using random forests for variable selection and multivariable Cox regression analysis. The model is represented by a visualized nomogram and a web-based calculator. The model performance was tested with the validation cohort and assessed using the C-statistic and calibration plots. RESULTS A total of 1179 patients were prospectively enrolled from February 1 to December 20, 2021. Among 816 patients with PAD who were included in the analysis, the median follow-up period for this study was 9 ± 4.07 months, the mean age was 74.64 ± 9.43 years, and 249 (30.5%) were women. Within 1 year, 222 patients (27.2%) developed MALE. Target lesion revascularizations were performed in 99 patients (12.1%), and amputations were performed in 131 patients (16.1%). The mortality rate within the whole cohort was 108 patients (13.2%). After controlling for competing risk events (death), the cumulative risk of developing MALE was not statistically different. Prealbumin (hazard ratio [HR], 0.6; 95% confidence interval [CI], 0.41-0.89; P = .010), percutaneous coronary intervention (HR, 2.31; 95% CI, 1.26-4.21; P = .006), Rutherford classification (HR, 1.77; 95% CI, 1.36-2.31; P < .001), white blood cell (HR, 1.85; 95% CI, 1.20-2.87; P = .005), high altitude area (HR, 3.1; 95% CI, 1.43-6.75; P = .004), endovascular treatment (HR, 10.2; 95% CI, 1.44-72.50; P = .020), and length of stay (HR, 1.01; 95% CI, 1.00-1.03; P = .012) were risk factors for MALE. The MALE prediction model had a C-statistic of 0.76 (95% CI, 0.70-0.79). The C-statistic was 0.68 for internal validation and 0.66 for external validation for the MALE prediction model. The MALE prediction model for PAD presented an interactive nomogram and a web-based network calculator. CONCLUSIONS In this study, the MALE prediction model has a discriminative ability to predict MALE among patients with PAD in frailty. The MALE model can optimize clinical decision-making for patients with PAD in frailty.
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Affiliation(s)
- Huarong Xiong
- Nursing School, Southwest Medical University, Luzhou, China; Affiliated Hospital of Southwest Medical University, Luzhou, China
| | - Dan Wang
- Nursing School, Southwest Medical University, Luzhou, China; Affiliated Hospital of Southwest Medical University, Luzhou, China
| | - Pan Song
- Nursing School, Southwest Medical University, Luzhou, China
| | - Xiaoyan Quan
- Nursing School, Southwest Medical University, Luzhou, China
| | - Mingfeng Zhang
- Department of Hepatology, The Affiliated Traditional Chinese Medicine Hospital of Southwest Medical University, Luzhou, China
| | - Siyuan Huang
- West China Hospital, Sichuan University, Chengdu, China
| | - Xiaoyu Liu
- Nursing School, Southwest Medical University, Luzhou, China
| | - Qin Chen
- Nursing School, Southwest Medical University, Luzhou, China; Affiliated Hospital of Southwest Medical University, Luzhou, China
| | - Xinxin He
- Center of Gerontology and Geriatrics, Department of Geriatrics and National Clinical Research Center for Geriatrics, West China Hospital, Sichuan University, Chengdu, China
| | - Xiuying Hu
- West China Hospital, Sichuan University, Chengdu, China; West China School of Nursing, Sichuan University/InNovation Center of Nursing Research, West China Hospital, Sichuan University/Nursing Key Laboratory of Sichuan Province, Chengdu, China
| | - Xi Yang
- Affiliated Hospital of Southwest Medical University, Luzhou, China
| | - Meihong Shi
- Nursing School, Southwest Medical University, Luzhou, China; West China School of Nursing, Sichuan University/InNovation Center of Nursing Research, West China Hospital, Sichuan University/Nursing Key Laboratory of Sichuan Province, Chengdu, China.
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Vosgin-Dinclaux V, Bertucat P, Dari L, Webster C, Foussard N, Mohammedi K, Ducasse E, Caradu C. Predictors of major adverse lower limb events in patients with tissue loss secondary to critical limb-threatening ischemia. CARDIOVASCULAR REVASCULARIZATION MEDICINE 2024; 64:34-41. [PMID: 38350775 DOI: 10.1016/j.carrev.2024.01.018] [Citation(s) in RCA: 1] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/18/2023] [Revised: 01/28/2024] [Accepted: 01/29/2024] [Indexed: 02/15/2024]
Abstract
BACKGROUND Chronic limb-threatening ischemia (CLTI) is the end-stage of peripheral arterial disease (PAD) posing a high risk for limb loss and mortality. This study aims to evaluate and list possible predictors of major adverse limb events (MALEs) in CLTI patients with tissue loss. METHODS This retrospective study included all Rutherford-Becker stage 5 or 6 patients who required foot debridement and revascularization in our department from January 2016 to December 2018. The limbs were classified according to the TASC II, GLASS and WiFI grading systems. The primary composite outcome was MALEs at 2 years. The secondary outcomes included all-cause mortality, primary patency, freedom from reintervention, and major amputation. Kaplan-Meier estimates were used to determine the event rates, and Cox proportional hazards model with the index MALE as a time-dependent covariate was used to search for MALEs predictors. RESULTS Of 241 included patients, 19 underwent open surgeries (7.9 %) 207 had endovascular interventions (85.9 %) and 15 required a hybrid approach (6.2 %). On univariate analysis, patients who experienced MALEs (n = 111) more often required hemodialysis (25 vs 15; p = .02), presented with more complex lesions (TASC D on femoropopliteal (p = .05) or below the knee (BTK) arteries (p = .006) with increasing infra-inguinal GLASS Stage (p < .0001)), a history of index limb open (p = .009) or endovascular (p = .049) revascularization, an occluded tibial artery (p = .002 for the posterior tibial and p = .052 for the anterior tibial), or a "desert foot" (p = .02). The CRP level was also higher at admission (p = .001). Technical success of BTK revascularization significantly reduced MALEs (p < .0001) along with the number of patent BTK vessels (p = .0007). Independent predictors of MALEs included hemodialysis (HR = 2.00; 95%CI: 1.14 to 3.39), pulsatile arterial pressure (HR = 1.01; 95%CI: 1.00 to 1.03) and the infra-inguinal GLASS Stage (HR = 2.50; 95%CI: 1.17 to 5.82). We could not correlate our results with the WiFI scores for amputation risk and revascularization benefit. CONCLUSION For patients with CLTI at the stage of trophic disorders, with or without a history of index limb revascularization, the GLASS successfully predicted MALEs. Hemodialysis and high pulsatile arterial pressure increased the risk of MALEs. The WiFI score did not demonstrate its interest in this subgroup of patients.
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Affiliation(s)
| | - Paul Bertucat
- Bordeaux University Hospital, Department of Vascular Surgery, Bordeaux, France
| | - Loubna Dari
- Bordeaux University Hospital, Hôpital Saint-André, Vascular Medicine Department, Bordeaux, France
| | - Claire Webster
- Imperial College London, Department of Vascular Surgery, London, UK
| | - Ninon Foussard
- Bordeaux University Hospital, Hôpital Haut-Lévêque, Department of Endocrinology, Diabetes and Nutrition, Pessac, France
| | - Kamel Mohammedi
- Bordeaux University Hospital, Hôpital Haut-Lévêque, Department of Endocrinology, Diabetes and Nutrition, Pessac, France
| | - Eric Ducasse
- Bordeaux University Hospital, Department of Vascular Surgery, Bordeaux, France
| | - Caroline Caradu
- Bordeaux University Hospital, Department of Vascular Surgery, Bordeaux, France.
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Cheng YT, Chang FL, Li PH, Lu WC, Chiu CS. Assessing the Suitability of CHA 2DS 2-VASc for Predicting Adverse Limb Events and Cardiovascular Outcomes in Peripheral Artery Disease Patients with Percutaneous Transluminal Angioplasty: A Retrospective Cohort Study. Biomedicines 2024; 12:1374. [PMID: 38927581 PMCID: PMC11202305 DOI: 10.3390/biomedicines12061374] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/27/2024] [Revised: 05/25/2024] [Accepted: 05/30/2024] [Indexed: 06/28/2024] Open
Abstract
Patients with peripheral artery disease (PAD) are at high risk of major adverse limb events (MALEs) and major adverse cardiovascular events (MACEs). CHA2DS2-VASc is a prognostic score for atrial fibrillation stroke risk; however, no study has evaluated its predictive ability for MALEs and MACEs in PAD patients who underwent percutaneous transluminal angioplasty. We conducted a retrospective cohort study on patients from Taiwan with PAD. The patients were stratified into four risk groups based on their modified CHA2DS2-VASc score. Cox proportional hazard models, 10-fold cross-validation, and receiver operating characteristic (ROC) analyses were utilized to evaluate the predictive ability of CHA2DS2-VASc for MALEs, MACEs, and MALEs + MACEs. Kaplan-Meier analysis estimated the survival probability of the risk groups. CHA2DS2-VASc was found to be a significant predictor of MACEs (hazard ratio (HR) 3.52 (95% confidence interval (95% CI) 1.00-12.12; p = 0.048), HR 4.18 (95% CI 1.19-14.36; p = 0.023), and HR 5.08 (95% CI 1.49-17.36; p = 0.009), for moderate-, high-, and very high-risk groups, respectively), while for MALEs and MALEs + MACEs, significance was achieved only for the high-risk group using a univariate model. For the multivariate adjusted model, the score was found to be a significant predictor of MACEs for only the very high-risk group, with an HR of 4.67 (95% CI 1.03-21.09; p = 0.045). The score demonstrated an AUC > 0.8, good discrimination (c-index > 0.8), and good calibration for predicting MACEs. However, it failed to achieve good performance for predicting MALEs and MALEs + MACEs. Based on all of the findings, CHA2DS2-VASc could potentially serve as a risk stratification score for predicting MACEs in patients with PAD, but it failed to qualify as a good predictor for MALEs.
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Affiliation(s)
- Yu-Tsung Cheng
- Cardiovascular Center, Taichung Veterans General Hospital, 1650 Section 4 Taiwan Boulevard, Xitun District, Taichung 40705, Taiwan;
| | - Fu-Lan Chang
- Department of Nursing, Taichung Veterans General Hospital, 1650 Section 4 Taiwan Boulevard, Xitun District, Taichung 40705, Taiwan;
| | - Po-Hsien Li
- Department of Food and Nutrition, Providence University, 200 Section 7, Taiwan Boulevard, Shalu District, Taichung City 43301, Taiwan;
| | - Wen-Chien Lu
- Department of Food and Beverage Management, Chung-Jen Junior College of Nursing, Health Sciences and Management, 217, Hung-Mao-Pi, Chiayi City 60077, Taiwan;
| | - Chien-Shan Chiu
- Department of Dermatology, Taichung Veterans General Hospital, 1650 Section 4 Taiwan Boulevard, Xitun District, Taichung 40705, Taiwan
- Department of Post-Baccalaureate Medicine, College of Medicine, National Chung Hsing University, 145 Xingda Road, South District, Taichung 402, Taiwan
- College of Biotechnology and Bioresources, Da-Yeh University, 168, University Road, Dacun, Changhua 51591, Taiwan
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Gornik HL, Aronow HD, Goodney PP, Arya S, Brewster LP, Byrd L, Chandra V, Drachman DE, Eaves JM, Ehrman JK, Evans JN, Getchius TSD, Gutiérrez JA, Hawkins BM, Hess CN, Ho KJ, Jones WS, Kim ESH, Kinlay S, Kirksey L, Kohlman-Trigoboff D, Long CA, Pollak AW, Sabri SS, Sadwin LB, Secemsky EA, Serhal M, Shishehbor MH, Treat-Jacobson D, Wilkins LR. 2024 ACC/AHA/AACVPR/APMA/ABC/SCAI/SVM/SVN/SVS/SIR/VESS Guideline for the Management of Lower Extremity Peripheral Artery Disease: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol 2024; 83:2497-2604. [PMID: 38743805 DOI: 10.1016/j.jacc.2024.02.013] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 05/23/2024]
Abstract
AIM The "2024 ACC/AHA/AACVPR/APMA/ABC/SCAI/SVM/SVN/SVS/SIR/VESS Guideline for the Management of Lower Extremity Peripheral Artery Disease" provides recommendations to guide clinicians in the treatment of patients with lower extremity peripheral artery disease across its multiple clinical presentation subsets (ie, asymptomatic, chronic symptomatic, chronic limb-threatening ischemia, and acute limb ischemia). METHODS A comprehensive literature search was conducted from October 2020 to June 2022, encompassing studies, reviews, and other evidence conducted on human subjects that was published in English from PubMed, EMBASE, the Cochrane Library, CINHL Complete, and other selected databases relevant to this guideline. Additional relevant studies, published through May 2023 during the peer review process, were also considered by the writing committee and added to the evidence tables where appropriate. STRUCTURE Recommendations from the "2016 AHA/ACC Guideline on the Management of Patients With Lower Extremity Peripheral Artery Disease" have been updated with new evidence to guide clinicians. In addition, new recommendations addressing comprehensive care for patients with peripheral artery disease have been developed.
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Gornik HL, Aronow HD, Goodney PP, Arya S, Brewster LP, Byrd L, Chandra V, Drachman DE, Eaves JM, Ehrman JK, Evans JN, Getchius TSD, Gutiérrez JA, Hawkins BM, Hess CN, Ho KJ, Jones WS, Kim ESH, Kinlay S, Kirksey L, Kohlman-Trigoboff D, Long CA, Pollak AW, Sabri SS, Sadwin LB, Secemsky EA, Serhal M, Shishehbor MH, Treat-Jacobson D, Wilkins LR. 2024 ACC/AHA/AACVPR/APMA/ABC/SCAI/SVM/SVN/SVS/SIR/VESS Guideline for the Management of Lower Extremity Peripheral Artery Disease: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation 2024; 149:e1313-e1410. [PMID: 38743805 DOI: 10.1161/cir.0000000000001251] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 05/16/2024]
Abstract
AIM The "2024 ACC/AHA/AACVPR/APMA/ABC/SCAI/SVM/SVN/SVS/SIR/VESS Guideline for the Management of Lower Extremity Peripheral Artery Disease" provides recommendations to guide clinicians in the treatment of patients with lower extremity peripheral artery disease across its multiple clinical presentation subsets (ie, asymptomatic, chronic symptomatic, chronic limb-threatening ischemia, and acute limb ischemia). METHODS A comprehensive literature search was conducted from October 2020 to June 2022, encompassing studies, reviews, and other evidence conducted on human subjects that was published in English from PubMed, EMBASE, the Cochrane Library, CINHL Complete, and other selected databases relevant to this guideline. Additional relevant studies, published through May 2023 during the peer review process, were also considered by the writing committee and added to the evidence tables where appropriate. STRUCTURE Recommendations from the "2016 AHA/ACC Guideline on the Management of Patients With Lower Extremity Peripheral Artery Disease" have been updated with new evidence to guide clinicians. In addition, new recommendations addressing comprehensive care for patients with peripheral artery disease have been developed.
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Rockhold M, Kunkel L, Lacoste JL, Szymanski T, Rothenberg P, Zimmerman P, Minc S. Comparison of direct oral anticoagulants and warfarin in chronic limb-threatening ischemia. J Vasc Surg 2024; 79:1466-1472.e1. [PMID: 38278371 PMCID: PMC11111331 DOI: 10.1016/j.jvs.2024.01.196] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/14/2023] [Revised: 01/17/2024] [Accepted: 01/19/2024] [Indexed: 01/28/2024]
Abstract
OBJECTIVE The role of direct oral anticoagulants (DOACs) in chronic limb-threatening ischemia after revascularization is unknown. Current evidence-based guidelines do not provide clear guidance on the role of anticoagulation or the selection of anticoagulant. Current practice is highly varied and based on provider and patient preference. The purpose of this study was to measure the impact of different anticoagulants on the incidence of major adverse limb events (MALEs) after revascularization for chronic limb-threatening ischemia, major adverse cardiovascular events (MACEs), all-cause mortality, and hospitalization for major bleeding events. METHODS This was a single-center, observational, retrospective cohort study. Subjects were eligible if they were 18 years or older; underwent endovascular or open revascularization for chronic limb-threatening ischemia, rest pain, or tissue loss; and were subsequently prescribed apixaban, rivaroxaban, or warfarin. The primary end point was the incidence of MALEs, including above-ankle amputation or major index-limb reintervention, within 1 year of index event. Secondary end points included the rate of all-cause mortality, MACEs, and incidence of International Society on Thrombosis and Haemostasis (ISTH) major bleeding. RESULTS From January 1, 2017, to September 20, 2022, 141 patients met the inclusion and exclusion criteria and were reviewed. The median age was 67 years, with 92 patients prescribed apixaban or rivaroxaban and 49 patients prescribed warfarin. Of these, 42 patients were prescribed triple antithrombotic therapy, 88 dual antithrombotic therapy, and 13 anticoagulant monotherapy. The primary outcome of 1-year MALEs occurred in 36.7% of the warfarin group and 33.7% of the DOAC group (relative risk [RR], 1.09; 95% CI, 0.53-2.25; P = .72). Secondary outcomes of 1-year MACEs (10.2% vs 4.3%; RR, 2.35; 95% CI, 0.60-9.18; P = .18) and 1-year all-cause mortality (26.5% vs 16.3%; RR, 1.63; 95% CI, 0.70-3.78; P = .15) did not differ between the groups. The secondary safety outcome of 1-year ISTH major bleeding occurred in 16.3% of the warfarin group and 4.3% of the DOAC group (RR, 3.76; 95% CI, 1.07-13.19; P = .015). CONCLUSIONS In patients with chronic limb-threatening ischemia who were revascularized and prescribed anticoagulation with apixaban, rivaroxaban, or warfarin on discharge, no difference in MALEs, MACEs, or all-cause mortality was found. However, 1-year admissions for ISTH major bleeding were significantly higher among patients prescribed warfarin. A randomized trial may confirm these findings.
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Affiliation(s)
- Matthew Rockhold
- West Virginia University Medicine, Department of Pharmacy, Morgantown, WV.
| | - Lauren Kunkel
- West Virginia University Medicine, Department of Pharmacy, Morgantown, WV
| | - Jordan L Lacoste
- West Virginia University Medicine, Department of Pharmacy, Morgantown, WV
| | - Thomas Szymanski
- West Virginia University Medicine, Department of Pharmacy, Morgantown, WV
| | - Paul Rothenberg
- West Virginia University Medicine, Department of General Surgery, Morgantown, WV
| | - Pamela Zimmerman
- West Virginia University Medicine, Department of Vascular Surgery, Morgantown, WV
| | - Samantha Minc
- West Virginia University Medicine, Department of Vascular Surgery, Morgantown, WV
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Matthay ZA, Pace WA, Smith EJ, Gutierrez RD, Gasper WJ, Hiramoto JS, Reilly LM, Conte MS, Iannuzzi JC. Predictors of amputation-free survival and wound healing after infrainguinal bypass with alternative conduits. J Vasc Surg 2024; 79:1447-1456.e2. [PMID: 38310981 DOI: 10.1016/j.jvs.2024.01.209] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/28/2023] [Revised: 01/24/2024] [Accepted: 01/28/2024] [Indexed: 02/06/2024]
Abstract
OBJECTIVE Inadequate vein quality or prior harvest precludes use of autologous single segment greater saphenous vein (ssGSV) in many patients with chronic limb-threatening ischemia (CLTI). Predictors of patient outcome after infrainguinal bypass with alternative (non-ssGSV) conduits are not well-understood. We explored whether limb presentation, bypass target, and conduit type were associated with amputation-free survival (AFS) after infrainguinal bypass using alternative conduits. METHODS A single-center retrospective study (2013-2020) was conducted of 139 infrainguinal bypasses performed for CLTI with cryopreserved ssGSV (cryovein) (n = 71), polytetrafluoroethylene (PTFE) (n = 23), or arm/spliced vein grafts (n = 45). Characteristics, Wound, Ischemia, and foot Infection (WIfI) stage, and outcomes were recorded. Multivariable Cox proportional hazards and classification and regression tree analysis modeled predictors of AFS. RESULTS Within 139 cases, the mean age was 71 years, 59% of patients were male, and 51% of cases were nonelective. More patients undergoing bypass with cryovein were WIfI stage 4 (41%) compared with PTFE (13%) or arm/spliced vein (27%) (P = .04). Across groups, AFS at 2 years was 78% for spliced/arm, 79% for PTFE, and 53% for cryovein (adjusted hazard ratio for cryovein, 2.5; P = .02). Among cases using cryovein, classification and regression tree analysis showed that WIfI stage 3 or 4, age >70 years, and prior failed bypass were predictive of the lowest AFS at 2 years of 36% vs AFS of 58% to 76% among subgroups with less than two of these factors. Although secondary patency at 2 years was worse in the cryovein group (26% vs 68% and 89% in arm/spliced and PTFE groups; P < .01), in patients with tissue loss there was no statistically significant difference in wound healing in the cryovein group (72%) compared with other bypass types (72% vs 87%, respectively; P = .12). CONCLUSIONS In patients with CLTI lacking suitable ssGSV, bypass with autogenous arm/spliced vein or PTFE has superior AFS compared with cryovein, although data were limited for PTFE conduits for distal targets. Despite poor patency with cryovein, wound healing is achieved in a majority of cases, although it should be used with caution in older patients with high WIfI stage and prior failed bypass, given the low rates of AFS.
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Affiliation(s)
- Zachary A Matthay
- Department of Surgery, University of California, San Francisco, San Francisco, CA
| | - William A Pace
- Department of Surgery, University of California, San Francisco, San Francisco, CA.
| | - Eric J Smith
- Department of Surgery, Division of Vascular and Endovascular Surgery, University of California, San Francisco, San Francisco, CA
| | - Richard D Gutierrez
- Department of Surgery, University of California, San Francisco, San Francisco, CA
| | - Warren J Gasper
- Department of Surgery, Division of Vascular and Endovascular Surgery, University of California, San Francisco, San Francisco, CA
| | - Jade S Hiramoto
- Department of Surgery, Division of Vascular and Endovascular Surgery, University of California, San Francisco, San Francisco, CA
| | - Linda M Reilly
- Department of Surgery, Division of Vascular and Endovascular Surgery, University of California, San Francisco, San Francisco, CA
| | - Michael S Conte
- Department of Surgery, Division of Vascular and Endovascular Surgery, University of California, San Francisco, San Francisco, CA
| | - James C Iannuzzi
- Department of Surgery, Division of Vascular and Endovascular Surgery, University of California, San Francisco, San Francisco, CA
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Chilbert MR, Woodruff AE, Rogers KC. A Practical Guide to Understanding and Treating Peripheral Artery Disease. J Cardiovasc Pharmacol 2024; 83:565-579. [PMID: 38452186 DOI: 10.1097/fjc.0000000000001556] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/18/2023] [Accepted: 02/20/2024] [Indexed: 03/09/2024]
Abstract
ABSTRACT Peripheral arterial disease (PAD) is the third leading cause of atherosclerotic morbidity after coronary heart disease and stroke yet is widely underdiagnosed and undertreated. Treatment of risk factors such as diabetes and cigarette smoking can benefit patients with PAD. Patients should have adequate blood pressure and lipid control to decrease clinical manifestations and symptoms of PAD. Use of antithrombotic medications should be individualized to the patient depending on the presence of symptoms, revascularization, and comorbidities. All patient care providers, including physicians, pharmacists, nurse practitioners, and physician assistants, should incorporate PAD screening in their at-risk patients to improve access for appropriate earlier diagnosis, initiation of guideline directed therapy, and risk factor modification to reduce both major adverse CV and limb outcomes. The purpose of this narrative review is to provide an overview of PAD and summarize clinical trial evidence and guideline recommendations for screening and treatment to increase awareness among health care providers to ultimately have a positive impact on patient care.
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Affiliation(s)
- Maya R Chilbert
- Department of Pharmacy, University at Buffalo, School of Pharmacy and Pharmaceutical Sciences, Buffalo General Medical Center; and
| | - Ashley E Woodruff
- Department of Pharmacy, University at Buffalo, School of Pharmacy and Pharmaceutical Sciences, Buffalo General Medical Center; and
| | - Kelly C Rogers
- The University of Tennessee Health Science Center College of Pharmacy
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40
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Fakhri YA, Al-Ani AW. Superoxide Dismutase and Clopidogrel: A Potential Role in Peripheral Arterial Disease Treatment. DOKL BIOCHEM BIOPHYS 2024; 516:83-92. [PMID: 38700818 DOI: 10.1134/s1607672924600088] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/24/2024] [Revised: 03/10/2024] [Accepted: 04/14/2024] [Indexed: 05/26/2024]
Abstract
Oxidative stress plays a crucial role in the pathogenesis of peripheral artery disease (PAD). This study aimed to investigate the effect of clopidogrel on oxidative stress in PAD patients. Seventy subjects were divided into three groups: PAD patients before treatment (B-PAD), PAD patients after treatment with clopidogrel (A-PAD), and healthy controls. Serum levels of superoxide dismutase (SOD), copper (Cu), zinc (Zn), manganese (Mn), and oxidized protein were measured. SOD activities were also determined. The results showed that SOD activities, and SOD specific activities were significantly decreased in PAD patients compared to healthy individuals. After treatment with clopidogrel, SOD activities, and SOD specific activities were continuously decrease in PAD patients. The SOD and oxidized protein concentrations were significantly increased in PAD patients compared to healthy individuals. After treatment with clopidogrel, the oxidized protein concentration was significantly decreased, while SOD concentration was significantly increased in PAD patients. These findings suggest that the treatment by clopidogrel stimulated the production of the enzyme but the ratio of active enzyme remained low. The decrease in oxidized protein can be explained by the treatment having antioxidant efficacy that may have compensated for the deficiency in enzyme activity and led to a decrease in oxidized protein. Additionally, the results of this study provide promising evidence that oxidative stress biomarkers including SOD concentration, T-SOD activity, Mn-SOD activity, and oxidized protein levels have potential utility in the diagnosis and management of PAD.
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Affiliation(s)
- Yasameen Ali Fakhri
- Department of Chemistry, College of Science, University of Baghdad, 10071, Baghdad, Iraq.
| | - Ali W Al-Ani
- Department of Chemistry, College of Science, University of Baghdad, 10071, Baghdad, Iraq
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41
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Bonaca MP, Bhatt DL, Simon T, Fox KM, Mehta S, Harrington RA, Leiter LA, Capell WH, Held C, Himmelmann A, Ridderstråle W, Chen J, Lee JJ, Song Y, Andersson M, Prats J, Kosiborod M, McGuire DK, Steg PG. Limb Outcomes With Ticagrelor Plus Aspirin in Patients With Diabetes Mellitus and Atherosclerosis. J Am Coll Cardiol 2024; 83:1627-1636. [PMID: 38658101 DOI: 10.1016/j.jacc.2024.03.377] [Citation(s) in RCA: 1] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/21/2023] [Revised: 02/26/2024] [Accepted: 03/05/2024] [Indexed: 04/26/2024]
Abstract
BACKGROUND Ticagrelor reduced major adverse cardiovascular events (MACE) and increased bleeding in patients with type 2 diabetes mellitus (T2DM) and coronary artery disease. Limb events including revascularization, acute limb ischemia (ALI), and amputation are major morbidities in patients with T2DM and atherosclerosis. OBJECTIVES This study sought to determine the effect of ticagrelor on limb events. METHODS Patients were randomized to ticagrelor or placebo on top of aspirin and followed for a median of 3 years. MACE (cardiovascular death, myocardial infarction, or stroke), limb events (ALI, amputation, revascularization), and bleeding were adjudicated by an independent and blinded clinical events committee. The presence of peripheral artery disease (PAD) was reported at baseline. RESULTS Of 19,220 patients randomized, 1,687 (8.8%) had PAD at baseline. In patients receiving placebo, PAD was associated with higher MACE (10.7% vs 7.3%; HR: 1.48; P < 0.001) and limb (9.5% vs 0.8%; HR: 10.67; P < 0.001) risk. Ticagrelor reduced limb events (1.6% vs 1.3%; HR: 0.77; 95% CI: 0.61-0.96; P = 0.022) with significant reductions for revascularization (HR: 0.79; 95% CI: 0.62-0.99; P = 0.044) and ALI (HR: 0.24; 95% CI: 0.08-0.70; P = 0.009). The benefit was consistent with or without PAD (HR: 0.80; 95% CI: 0.58-1.11; and HR: 0.76; 95% CI: 0.55-1.05, respectively; Pinteraction = 0.81). There was no effect modification of ticagrelor vs placebo based on PAD for MACE (Pinteraction = 0.40) or TIMI major bleeding (Pinteraction = 0.3239). CONCLUSIONS Patients with T2DM and atherosclerosis are at high risk of limb events. Ticagrelor decreased this risk, but increased bleeding. Future trials evaluating the combination of ticagrelor and aspirin would further elucidate the benefit/risk of such therapy in patients with PAD, including those without coronary artery disease. (A Study Comparing Cardiovascular Effects of Ticagrelor Versus Placebo in Patients With Type 2 Diabetes Mellitus [THEMIS]: NCT01991795).
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Affiliation(s)
- Marc P Bonaca
- University of Colorado, CPC Clinical Research, Aurora, Colorado, USA.
| | - Deepak L Bhatt
- Mount Sinai Heart, Icahn School of Medicine at Mount Sinai Health System, New York, New York, USA
| | - Tabassome Simon
- Department of Clinical Pharmacology and Clinical Research, Research Platform of East of Paris (URCEST-CRCEST-CRB.APHPSU), Assistance Publique Hopitaux de Paris (APHP), Sorbonne Universite, FACT (French Alliance for Cardiovascular Trials), Paris, France
| | - Kim Michael Fox
- The National Heart and Lung Institute, Imperial College and Royal Brompton Hospital, London, United Kingdom
| | - Shamir Mehta
- Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, Ontario, Canada
| | | | - Lawrence A Leiter
- Li Ka Shing Knowledge Institute, St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada
| | - Warren H Capell
- University of Colorado, CPC Clinical Research, Aurora, Colorado, USA
| | - Claes Held
- Department of Medical Sciences, Cardiology, Uppsala University, Uppsala Clinical Research Center, Uppsala, Sweden
| | - Anders Himmelmann
- AstraZeneca BioPharmaceuticals R&D, Late-stage Development, Cardiovascular, Renal and Metabolic, Gothenburg, Sweden
| | - Wilhelm Ridderstråle
- AstraZeneca BioPharmaceuticals R&D, Late-stage Development, Cardiovascular, Renal and Metabolic, Gothenburg, Sweden
| | - Jersey Chen
- AstraZeneca BioPharmaceuticals R&D, Late-stage Development, Cardiovascular, Renal and Metabolic, Gothenburg, Sweden
| | - Jane J Lee
- Baim Institute for Clinical Research, Boston, Massachusetts, USA
| | - Yang Song
- Baim Institute for Clinical Research, Boston, Massachusetts, USA
| | - Marielle Andersson
- AstraZeneca BioPharmaceuticals R&D, Late-stage Development, Cardiovascular, Renal and Metabolic, Gothenburg, Sweden
| | | | - Mikhail Kosiborod
- Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City, Missouri, USA
| | - Darren K McGuire
- University of Texas Southwestern Medical Center, and Parkland Health and Hospital System, Dallas, Texas, USA
| | - Ph Gabriel Steg
- French Alliance for Cardiovascular Trials, Département Hospitalo-Universitaire FIRE, Hôpital Bichat, Université de Paris, INSERM Unité 1148, Paris, France
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42
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Sun X, Zhang C, Ma Y, He Y, Zhang X, Wu J. Association between diabetes mellitus and primary restenosis following endovascular treatment: a comprehensive meta-analysis of randomized controlled trials. Cardiovasc Diabetol 2024; 23:132. [PMID: 38650038 PMCID: PMC11036687 DOI: 10.1186/s12933-024-02201-6] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/28/2024] [Accepted: 03/14/2024] [Indexed: 04/25/2024] Open
Abstract
IMPORTANCE Diabetes mellitus (DM) is thought to be closely related to arterial stenotic or occlusive disease caused by atherosclerosis. However, there is still no definitive clinical evidence to confirm that patients with diabetes have a higher risk of restenosis. OBJECTIVE This meta-analysis was conducted to determine the effect of DM on restenosis among patients undergoing endovascular treatment, such as percutaneous transluminal angioplasty (PTA) or stenting. DATA SOURCES AND STUDY SELECTION The PubMed/Medline, EMBASE and Cochrane Library electronic databases were searched from 01/1990 to 12/2022, without language restrictions. Trials were included if they satisfied the following eligibility criteria: (1) RCTs of patients with or without DM; (2) lesions confined to the coronary arteries or femoral popliteal artery; (3) endovascular treatment via PTA or stenting; and (4) an outcome of restenosis at the target lesion site. The exclusion criteria included the following: (1) greater than 20% of patients lost to follow-up and (2) a secondary restenosis operation. DATA EXTRACTION AND SYNTHESIS Two researchers independently screened the titles and abstracts for relevance, obtained full texts of potentially eligible studies, and assessed suitability based on inclusion and exclusion criteria.. Disagreements were resolved through consultation with a third researcher. Treatment effects were measured by relative ratios (RRs) with 95% confidence intervals (CIs) using random effects models. The quality of the evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) criteria. MAIN OUTCOMES AND MEASURES The main observation endpoint was restenosis, including > 50% stenosis at angiography, or TLR of the primary operation lesion during the follow-up period. RESULTS A total of 31,066 patients from 20 RCTs were included. Patients with DM had a higher risk of primary restenosis after endovascular treatment (RR = 1.43, 95% CI: 1.25-1.62; p = 0.001). CONCLUSIONS AND RELEVANCE This meta-analysis of all currently available RCTs showed that patients with DM are more prone to primary restenosis after endovascular treatment.
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Affiliation(s)
- Xiaolei Sun
- Department of General Surgery (Vascular Surgery), Affiliated Hospital of Southwest Medical University, Luzhou, 646000, China.
- Department of Interventional Medicine, Affiliated Hospital of Southwest Medical University, Luzhou, 646000, China.
- Laboratory of Nucleic Acids in Medicine for National High-Level Talents, Nucleic Acid Medicine of Luzhou Key Laboratory, Southwest Medical University, Luzhou, 646000, China.
- Key Laboratory of Medical Electrophysiology, Ministry of Education and Medical Electrophysiological Key Laboratory of Sichuan Province, Collaborative Innovation Center for Prevention and Treatment of Cardiovascular Disease of Sichuan Province, Institute of Cardiovascular Research, Southwest Medical University, Luzhou, 646000, China.
- Cardiovascular and Metabolic Diseases Key Laboratory of Luzhou, Luzhou, 646000, China.
- School of Cardiovascular Medicine and Sciences, Faculty of Life Science and Medicine, King's College London British Heart Foundation Centre of Research Excellence, King's College London, London, SE5 9NU, UK.
| | - Cheng Zhang
- Department of General Surgery, Center of Vascular and Interventional Surgery, The Third People's Hospital of Chengdu, The Affiliated Hospital of Southwest Jiaotong University &The Second Affiliated Hospital of Chengdu, Chongqing Medical University, Chengdu, 610031, China
| | - Yarong Ma
- Department of Ophthalmology, Affiliated Hospital of Southwest Medical University, Luzhou, 646000, China
| | - Yanzheng He
- Department of General Surgery (Vascular Surgery), Affiliated Hospital of Southwest Medical University, Luzhou, 646000, China
| | - Xiaodong Zhang
- Chongqing Clinical Research Center for Reproductive Medicine, Center for Reproductive Medicine, Women and Children's Hospital of Chongqing Medical University, Chongqing, China.
| | - Jianbo Wu
- Department of Pharmacology, Basic Medicine Research Innovation Center for Cardiometabolic Diseases, Ministry of Education, and Laboratory for Cardiovascular Pharmacology, School of Pharmacy, Southwest Medical University, Luzhou, 646000, China.
- Key Laboratory of Medical Electrophysiology, Ministry of Education and Medical Electrophysiological Key Laboratory of Sichuan Province, Collaborative Innovation Center for Prevention and Treatment of Cardiovascular Disease of Sichuan Province, Institute of Cardiovascular Research, Southwest Medical University, Luzhou, 646000, China.
- Cardiovascular and Metabolic Diseases Key Laboratory of Luzhou, Luzhou, 646000, China.
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43
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Altunova M, Karakayali M, Yildirim Karakan C, Tükenmez Karakurt S, Demirci G, Aslan S, Guler A, Evsen A, Erturk M. The relationship between plasma atherogenic index and long-term outcomes after endovascular intervention in superficial femoral artery lesions. Vascular 2024; 32:310-319. [PMID: 37540809 DOI: 10.1177/17085381231193494] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 08/06/2023]
Abstract
OBJECTIVES Peripheral arterial disease (PAD) results from the systemic atherosclerotic process. In this study, we aimed to determine the relationship between plasma atherogenic index (AIP), a ratio of molar concentrations of triglycerides to HDL-cholesterol, and long-term outcomes after endovascular therapy (EVT) in patients with superficial femoral artery (SFA) stenosis. METHODS We retrospectively evaluated 673 patients who underwent EVT for PAD in our tertiary center between January 2015 and December 2020. In the receiver operating characteristic (ROC) curve analysis, the AIP value with the optimum cutoff value was determined as 0.576 to detect the presence of major adverse limb events (MALEs). Patients were divided into two groups according to low AIP (<0.576 as group 1) and high AIP (>0.576 as group 2). RESULTS Among the major endpoints, long-term restenosis rates were significantly higher in patients in the high-AIP group than in the low-AIP group (p<.001). The lower extremity amputation rate was not statistically significant between the two groups. All-cause mortality rate (54 (31.6) versus 117 (68.4), p<.001) was significantly higher in patients in the high-AIP group than in the low-AIP group. In addition, the MALE rate (94 (29.2) versus 218 (62.1), p<.001) was significantly higher in patients in the high-AIP group than in those in the low-AIP group. CONCLUSIONS In conclusion, we found that AIP is a significant independent predictor of long-term MALE in patients who underwent EVT for SFA.
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Affiliation(s)
- Mehmet Altunova
- Department of Cardiology, Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Training and Research Hospital, University of Health Sciences, Istanbul, Turkey
| | - Muammer Karakayali
- Department of Cardiology, Faculty of Medicine, Kafkas University, Kars, Turkey
| | - Ceren Yildirim Karakan
- Department of Cardiology, Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Training and Research Hospital, University of Health Sciences, Istanbul, Turkey
| | - Seda Tükenmez Karakurt
- Department of Cardiology, Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Training and Research Hospital, University of Health Sciences, Istanbul, Turkey
| | - Gokhan Demirci
- Department of Cardiology, Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Training and Research Hospital, University of Health Sciences, Istanbul, Turkey
| | - Serkan Aslan
- Department of Cardiology, Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Training and Research Hospital, University of Health Sciences, Istanbul, Turkey
| | - Arda Guler
- Department of Cardiology, Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Training and Research Hospital, University of Health Sciences, Istanbul, Turkey
| | - Ali Evsen
- Department of Cardiology, Faculty of Medicine, Dicle University, Diyarbakir, Turkey
| | - Mehmet Erturk
- Department of Cardiology, Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Training and Research Hospital, University of Health Sciences, Istanbul, Turkey
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44
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Meloni M, Piaggesi A, Uccioli L. From a Spark to a Flame: The Evolution of Diabetic Foot Disease in the Last Two Decades. INT J LOW EXTR WOUND 2024:15347346241238480. [PMID: 38470358 DOI: 10.1177/15347346241238480] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 03/13/2024]
Abstract
Despite many improvements have been achieved, diabetic foot disease (DFD) remains a clinical, social, and economic burden. In the last years, DFD showed an evolution of its characteristics with an increase of the ischaemic/neuro-ischaemic foot in comparison to the pure neuropathic foot. Simultaneously, there was and increased incidence of concomitant cardiovascular co-morbidities, which influences the higher fragility of patients with DFS. Peripheral arterial disease (PAD) in subjects with diabetic foot seems to show a more aggressive pattern, being more distal and difficult to treat. Untreatable PAD remains the unmet need for clinicians and the main risk factor of major amputation in patients with diabetic foot ulcers. Authors aimed to describe the evolution of diabetic foot patients in the last two decades, describing also the current and future treatment which may improve outcomes in the next generations.
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Affiliation(s)
- Marco Meloni
- Department of Systems Medicine, University of Rome Tor Vergata, Rome, Italy
- University Hospital Fondazione Policlinico Tor Vergata, Rome, Italy
| | - Alberto Piaggesi
- Diabetic Foot Section, Department of Endocrinology and Metabolism, University of Pisa, Pisa, Italy
| | - Luigi Uccioli
- Department of Systems Medicine, University of Rome Tor Vergata, Rome, Italy
- University Hospital Fondazione Policlinico Tor Vergata, Rome, Italy
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45
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Fitridge R, Chuter V, Mills J, Hinchliffe R, Azuma N, Behrendt CA, Boyko EJ, Conte MS, Humphries M, Kirksey L, McGinigle KC, Nikol S, Nordanstig J, Rowe V, Russell D, van den Berg JC, Venermo M, Schaper N. The intersocietal IWGDF, ESVS, SVS guidelines on peripheral artery disease in people with diabetes and a foot ulcer. Diabetes Metab Res Rev 2024; 40:e3686. [PMID: 37726988 DOI: 10.1002/dmrr.3686] [Citation(s) in RCA: 14] [Impact Index Per Article: 14.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 09/21/2023]
Abstract
Diabetes related foot complications have become a major cause of morbidity and are implicated in most major and minor amputations globally. Approximately 50% of people with diabetes and a foot ulcer have peripheral artery disease (PAD) and the presence of PAD significantly increases the risk of adverse limb and cardiovascular events. The International Working Group on the Diabetic Foot (IWGDF) has published evidence based guidelines on the management and prevention of diabetes related foot complications since 1999. This guideline is an update of the 2019 IWGDF guideline on the diagnosis, prognosis and management of peripheral artery disease in people with diabetes mellitus and a foot ulcer. For this guideline the IWGDF, the European Society for Vascular Surgery and the Society for Vascular Surgery decided to collaborate to develop a consistent suite of recommendations relevant to clinicians in all countries. This guideline is based on three new systematic reviews. Using the Grading of Recommendations, Assessment, Development, and Evaluation framework clinically relevant questions were formulated, and the literature was systematically reviewed. After assessing the certainty of the evidence, recommendations were formulated which were weighed against the balance of benefits and harms, patient values, feasibility, acceptability, equity, resources required, and when available, costs. Through this process five recommendations were developed for diagnosing PAD in a person with diabetes, with and without a foot ulcer or gangrene. Five recommendations were developed for prognosis relating to estimating likelihood of healing and amputation outcomes in a person with diabetes and a foot ulcer or gangrene. Fifteen recommendations were developed related to PAD treatment encompassing prioritisation of people for revascularisation, the choice of a procedure and post-surgical care. In addition, the Writing Committee has highlighted key research questions where current evidence is lacking. The Writing Committee believes that following these recommendations will help healthcare professionals to provide better care and will reduce the burden of diabetes related foot complications.
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Affiliation(s)
- Robert Fitridge
- Faculty of Health and Medical Sciences, University of Adelaide and Vascular and Endovascular Service, Royal Adelaide Hospital, Adelaide, South Australia, Australia
| | - Vivienne Chuter
- School of Health Sciences, Western Sydney University, Campbelltown, New South Wales, Australia
| | | | - Robert Hinchliffe
- Bristol Centre for Surgical Research, University of Bristol, Bristol, UK
| | | | - Christian-Alexander Behrendt
- Department of Vascular and Endovascular Surgery, Asklepios Clinic Wandsbek, Asklepios Medical School, Hamburg, Germany
| | | | - Michael S Conte
- San Francisco Medical Centre, University of California, San Francisco, California, USA
| | | | | | | | - Sigrid Nikol
- Clinical and Interventional Angiology, Asklepios Klinik, St Georg, Hamburg, Germany
| | | | - Vincent Rowe
- David Geffen School of Medicine, UCLA, Los Angeles, California, USA
| | | | - Jos C van den Berg
- CENTRO VASCOLARE TICINO Ospedale Regionale di Lugano, sede Civico and Universitätsinstitut für Diagnostische, Interventionelle und Pädiatrische Radiologie Inselspital, Universitätsspital, Bern, Switzerland
| | - Maarit Venermo
- Helsinki University Hospital, University of Helsinki, Helsinki, Finland
| | - Nicolaas Schaper
- Division of Endocrinology, Department Internal Medicine, MUMC+, Maastricht, The Netherlands
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Lazzarini PA, Raspovic KM, Meloni M, van Netten JJ. A new declaration for feet's sake: Halving the global diabetic foot disease burden from 2% to 1% with next generation care. Diabetes Metab Res Rev 2024; 40:e3747. [PMID: 37997627 DOI: 10.1002/dmrr.3747] [Citation(s) in RCA: 14] [Impact Index Per Article: 14.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/30/2023] [Accepted: 10/31/2023] [Indexed: 11/25/2023]
Abstract
The 1989 Saint Vincent Declaration established a goal of halving global diabetes-related amputation rates. A generation later, this goal has been achieved for major but not minor amputations. However, diabetic foot disease (DFD) is not only a leading cause of global amputation but also of hospitalisation, poor quality of life (QoL) and disability burdens. In this paper, we review latest estimates on the global disease burden of DFD and the next generation care of DFD that could reduce this burden. We found DFD causes 2% of the global disease burden. This makes DFD the 13th largest of 350+ leading conditions causing the global disease burden, and much larger than dementia, breast cancer and type 1 diabetes. Neuropathy without ulcers and amputations makes up the largest portion of the global DFD burden yet receives the least DFD focus. Future care focussed on improving safe physical activity in people with DFD could considerably reduce the DFD burden, as this incorporates increasing physical fitness and QoL, while simultaneously decreasing ulceration and other risks. Charcot neuro-osteoarthropathy is more prevalent than previously thought. Most cases respond well to non-removable offloading devices, but surgical intervention may further reduce the considerable burden of these neuropathic fracture dislocations. Ischaemia is becoming more common and complex. Most cases respond well to revascularisation interventions, but novel revascularisation techniques, medical management and autologous cell therapies may hold the key to more cases responding in the future. We conclude that DFD causes a global disease burden larger than most conditions and existing guideline-based care and next generation treatments can reduce this burden. We suggest the World Health Organization and International Diabetes Federation declare a new goal: halving the global DFD burden from 2% to 1% within the next generation.
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Affiliation(s)
- Peter A Lazzarini
- School of Public Health and Social Work, Queensland University of Technology, Brisbane, Queensland, Australia
- Allied Health Research Collaborative, The Prince Charles Hospital, Brisbane, Queensland, Australia
| | - Katherine M Raspovic
- Department of Orthopaedic Surgery, University of Texas Southwestern Medical Center, Dallas, Texas, USA
| | - Marco Meloni
- Department of Systems Medicine, University of Rome Tor Vergata, Rome, Italy
| | - Jaap J van Netten
- Department of Rehabilitation Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands
- Amsterdam Movement Sciences, Program Rehabilitation, Amsterdam, The Netherlands
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47
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Yu Q, Chen C, Cao J, Xu J, Lu J, Yuan L. Efficiency and safety of dual pathway inhibition for the prevention of femoropopliteal artery restenosis in repeated endovascular interventions. J Vasc Surg 2024; 79:623-631.e2. [PMID: 37951514 DOI: 10.1016/j.jvs.2023.11.005] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/22/2023] [Revised: 10/18/2023] [Accepted: 11/03/2023] [Indexed: 11/14/2023]
Abstract
OBJECTIVE There is a lack of consensus regarding the optimal strategy for evaluating the efficiency and safety of dual-pathway inhibition (DPI) in preventing femoropopliteal restenosis in patients undergoing repeated endovascular interventions. Despite several therapeutic interventions available for preventing femoropopliteal restenosis post repeated endovascular interventions, the ideal strategy, particularly evaluating the efficacy and safety of DPI, remains a matter of debate. METHODS From January 2015 to September 2021, patients who underwent repeated endovascular interventions for femoropopliteal restenosis were compared with those who underwent DPI or dual antiplatelet therapy (DAPT) after surgery using a propensity score-matched analysis. The primary outcome was clinically driven target lesion revascularization (CD-TLR). The principal safety outcome was a composite of major bleeding and clinically relevant non-major (CRNM) bleeding. To further enhance the rigor, Kaplan-Meier plots, Cox proportional hazards modeling, and sensitivity analyses, as well as subgroup analyses were employed, reducing potential confounders. RESULTS A total of 441 patients were included in our study, of whom 294 (66.7%) received DAPT and 147 (33.1%) received DPI, with 114 matched pairs (mean age, 72.21 years; 84.2% male). Cumulative probability of CD-TLR at 36 months in the DPI group (17%) trended lower than that in the DAPT group (32%) (hazard ratio [HR], 0.45; 95% confidence interval [CI], 0.26-0.78; P =.004). The cumulative probability of freedom from CD-TLR at 36 months in the DPI group was 83%. No significant difference was observed in the composite outcome of major or CRNM bleeding between the DPI and DAPT groups (HR, 1.26; 95% CI, 0.34 to 4.69; P = .730). The DPI group was associated with significantly lower rates of CD-TLR in the main subgroup analyses of diabetes (P = .001), previous smoking history (P = .008), longer lesion length (>10 cm) (P = .003), and treatment with debulking strategy (P = .003). CONCLUSIONS In our investigation focused on CD-TLR, we found that DPI exhibited a significant reduction in the risk of reintervention compared with other treatment modalities. This underscores the potential of DPI as a viable therapeutic strategy in preventing reinterventions. Moreover, our assessment of safety outcomes revealed that the bleeding risks associated with DPI were on par with DAPT, thereby not compromising patient safety. These findings pave the way for potential broader clinical implications, emphasizing the effectiveness and safety of DPI in the context of reducing reintervention risks.
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Affiliation(s)
- Qingyuan Yu
- Department of Vascular Surgery, Changhai Hospital, Navy Military Medical University, Shanghai, China
| | - Cheng Chen
- ChangZheng Hospital, Navy Military Medical University, Shanghai, China
| | - Jingzhu Cao
- Department of Endocrinology, Changhai Hospital, Navy Military Medical University, Shanghai, China
| | - Jinyan Xu
- Department of Vascular Surgery, Changhai Hospital, Navy Military Medical University, Shanghai, China
| | - Jin Lu
- Department of Endocrinology, Changhai Hospital, Navy Military Medical University, Shanghai, China
| | - Liangxi Yuan
- Department of Vascular Surgery, Changhai Hospital, Navy Military Medical University, Shanghai, China.
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48
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Martin SS, Aday AW, Almarzooq ZI, Anderson CAM, Arora P, Avery CL, Baker-Smith CM, Barone Gibbs B, Beaton AZ, Boehme AK, Commodore-Mensah Y, Currie ME, Elkind MSV, Evenson KR, Generoso G, Heard DG, Hiremath S, Johansen MC, Kalani R, Kazi DS, Ko D, Liu J, Magnani JW, Michos ED, Mussolino ME, Navaneethan SD, Parikh NI, Perman SM, Poudel R, Rezk-Hanna M, Roth GA, Shah NS, St-Onge MP, Thacker EL, Tsao CW, Urbut SM, Van Spall HGC, Voeks JH, Wang NY, Wong ND, Wong SS, Yaffe K, Palaniappan LP. 2024 Heart Disease and Stroke Statistics: A Report of US and Global Data From the American Heart Association. Circulation 2024; 149:e347-e913. [PMID: 38264914 DOI: 10.1161/cir.0000000000001209] [Citation(s) in RCA: 659] [Impact Index Per Article: 659.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/25/2024]
Abstract
BACKGROUND The American Heart Association (AHA), in conjunction with the National Institutes of Health, annually reports the most up-to-date statistics related to heart disease, stroke, and cardiovascular risk factors, including core health behaviors (smoking, physical activity, nutrition, sleep, and obesity) and health factors (cholesterol, blood pressure, glucose control, and metabolic syndrome) that contribute to cardiovascular health. The AHA Heart Disease and Stroke Statistical Update presents the latest data on a range of major clinical heart and circulatory disease conditions (including stroke, brain health, complications of pregnancy, kidney disease, congenital heart disease, rhythm disorders, sudden cardiac arrest, subclinical atherosclerosis, coronary heart disease, cardiomyopathy, heart failure, valvular disease, venous thromboembolism, and peripheral artery disease) and the associated outcomes (including quality of care, procedures, and economic costs). METHODS The AHA, through its Epidemiology and Prevention Statistics Committee, continuously monitors and evaluates sources of data on heart disease and stroke in the United States and globally to provide the most current information available in the annual Statistical Update with review of published literature through the year before writing. The 2024 AHA Statistical Update is the product of a full year's worth of effort in 2023 by dedicated volunteer clinicians and scientists, committed government professionals, and AHA staff members. The AHA strives to further understand and help heal health problems inflicted by structural racism, a public health crisis that can significantly damage physical and mental health and perpetuate disparities in access to health care, education, income, housing, and several other factors vital to healthy lives. This year's edition includes additional global data, as well as data on the monitoring and benefits of cardiovascular health in the population, with an enhanced focus on health equity across several key domains. RESULTS Each of the chapters in the Statistical Update focuses on a different topic related to heart disease and stroke statistics. CONCLUSIONS The Statistical Update represents a critical resource for the lay public, policymakers, media professionals, clinicians, health care administrators, researchers, health advocates, and others seeking the best available data on these factors and conditions.
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Grubman S, Algara M, Smolderen KG, Luna P, Walenczyk K, Scierka L, Cleman J, Siddiqui WT, Romain G, Mena‐Hurtado C. Examining Outcomes in Patients Admitted With Comorbid Peripheral Artery Disease and Microvascular Disease. J Am Heart Assoc 2024; 13:e030710. [PMID: 38166496 PMCID: PMC10863818 DOI: 10.1161/jaha.123.030710] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/23/2023] [Accepted: 11/03/2023] [Indexed: 01/04/2024]
Abstract
BACKGROUND Peripheral artery disease (PAD) and microvascular disease (MVD) are highly prevalent conditions that share common risk factors. This observational study aimed to characterize patients with both conditions and determine the impact of comorbid PAD/MVD on outcomes. METHODS AND RESULTS Patients admitted across 31 states January 2011 through December 2018 with a primary or secondary diagnosis of PAD or MVD were included from the National Readmissions Database and weighted to approximate a national sample. Those age <18 years or with nonatherosclerotic leg injuries were excluded. Patients were divided into 3 groups: PAD-only, MVD-only, or comorbid PAD/MVD. Multiple logistic regression was used to evaluate associations with major and minor amputations, major adverse cardiac events, and in-hospital mortality. Cox regression was used to evaluate associations with readmission within 1 year. The PAD group was used as reference. The final cohort included 33 972 772 admissions: 9.1 million with PAD, 21.3 million with MVD, and 3.6 million with both. Annual admissions for PAD/MVD increased to >500 000 in 2018. Major and minor amputations increased ≈50% for PAD/MVD between 2011 and 2018. Compared with PAD-only, PAD/MVD was associated with a higher risk for major amputation (odds ratio [OR], 1.30 [95% CI, 1.28-1.32]), minor amputation (OR, 2.15 [95% CI, 2.12-2.18]), major adverse cardiac events (OR, 1.04 [95% CI, 1.03-1.04]), in-hospital mortality (OR, 1.07 [95% CI, 1.05-1.09]), and readmission (hazard ratio, 1.02 [95% CI, 1.02-1.02]) after adjustment for baseline factors. CONCLUSIONS Comorbid MVD is present in a large and growing number of patients with PAD and is associated with augmented risk for adverse outcomes. Further prospective research is merited to understand this vulnerable population.
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Affiliation(s)
- Scott Grubman
- Vascular Medicine Outcomes Program (VAMOS), Division of Cardiology, Department of MedicineYale School of MedicineNew HavenCT
| | - Miguel Algara
- Vascular Medicine Outcomes Program (VAMOS), Division of Cardiology, Department of MedicineYale School of MedicineNew HavenCT
- Department of Internal MedicineHarvard Medical SchoolBostonMA
| | - Kim G. Smolderen
- Vascular Medicine Outcomes Program (VAMOS), Division of Cardiology, Department of MedicineYale School of MedicineNew HavenCT
- Department of PsychiatryYale School of MedicineNew HavenCT
| | - Paulina Luna
- Vascular Medicine Outcomes Program (VAMOS), Division of Cardiology, Department of MedicineYale School of MedicineNew HavenCT
- Department of Internal MedicineWeill Cornell MedicineNew YorkNY
| | - Kristie Walenczyk
- Vascular Medicine Outcomes Program (VAMOS), Division of Cardiology, Department of MedicineYale School of MedicineNew HavenCT
| | - Lindsey Scierka
- Vascular Medicine Outcomes Program (VAMOS), Division of Cardiology, Department of MedicineYale School of MedicineNew HavenCT
| | - Jacob Cleman
- Vascular Medicine Outcomes Program (VAMOS), Division of Cardiology, Department of MedicineYale School of MedicineNew HavenCT
| | - Waleed Tariq Siddiqui
- Vascular Medicine Outcomes Program (VAMOS), Division of Cardiology, Department of MedicineYale School of MedicineNew HavenCT
| | - Gaëlle Romain
- Vascular Medicine Outcomes Program (VAMOS), Division of Cardiology, Department of MedicineYale School of MedicineNew HavenCT
| | - Carlos Mena‐Hurtado
- Vascular Medicine Outcomes Program (VAMOS), Division of Cardiology, Department of MedicineYale School of MedicineNew HavenCT
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Erzinger FL, Polimanti AC, Pinto DM, Murta G, Cury MV, Silva RBD, Biagioni RB, Belckzac SQ, Joviliano EE, Araujo WJBD, Oliveira JCPD. Diretrizes sobre doença arterial periférica da Sociedade Brasileira de Angiologia e Cirurgia Vascular. J Vasc Bras 2024; 23. [DOI: 10.1590/1677-5449.202300591] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/07/2025] Open
Abstract
Resumo Pacientes com doença arterial periférica e aterosclerose generalizada apresentam alto risco de complicações cardiovasculares e nos membros, o que afeta sua qualidade de vida e longevidade. A doença aterosclerótica das extremidades inferiores está associada à alta morbimortalidade cardiovascular, sendo necessário para sua adequada terapia realizar o tratamento dos fatores dependentes do paciente, como a modificação no estilo de vida, e dos fatores dependentes do médico, como o tratamento clínico, tratamento endovascular ou cirurgia convencional. A abordagem médica para a doença arterial periférica é multifacetada, e inclui como principais medidas a redução do nível do colesterol, a terapia antitrombótica, o controle da pressão arterial e do diabetes e a cessação do tabagismo. A adesão a esse regime pode reduzir as complicações relacionadas aos membros, como a isquemia crônica que ameaça o membro e pode levar à sua amputação, e as complicações sistêmicas da aterosclerose, como o acidente vascular cerebral e infarto do miocárdio.
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Affiliation(s)
- Fabiano Luiz Erzinger
- Hospital Erasto Gaertner, Brasil; Sociedade Brasileira de Angiologia e de Cirurgia Vascular, Brasil; Instituto da Circulação, Brasil
| | | | - Daniel Mendes Pinto
- Sociedade Brasileira de Angiologia e de Cirurgia Vascular, Brasil; Hospital Felicio Rocho Ringgold, Brasil
| | - Gustavo Murta
- Sociedade Brasileira de Angiologia e de Cirurgia Vascular, Brasil; Rede Mater Dei de Saúde, Brasil
| | - Marcus Vinicius Cury
- Sociedade Brasileira de Angiologia e de Cirurgia Vascular, Brasil; Instituto de Assistência ao Servidor Público Estadual de São Paulo, Brasil
| | - Ricardo Bernardo da Silva
- Sociedade Brasileira de Angiologia e de Cirurgia Vascular, Brasil; Pontifícia Universidade Católica do Paraná, Brasil; Santa Casa de Londrina, Brasil
| | - Rodrigo Bruno Biagioni
- Sociedade Brasileira de Angiologia e de Cirurgia Vascular, Brasil; Instituto de Assistência ao Servidor Público Estadual de São Paulo, Brasil; Sociedade Brasileira de Radiologia Intervencionista e Cirurgia Endovascular, Brasil
| | - Sergio Quilici Belckzac
- Sociedade Brasileira de Angiologia e de Cirurgia Vascular, Brasil; Instituto de Aprimoramento e Pesquisa em Angiorradiologia e Cirurgia Endovascular, Brasil
| | - Edwaldo Edner Joviliano
- Sociedade Brasileira de Angiologia e de Cirurgia Vascular, Brasil; Universidade de São Paulo, Brasil
| | - Walter Junior Boin de Araujo
- Sociedade Brasileira de Angiologia e de Cirurgia Vascular, Brasil; Instituto da Circulação, Brasil; Universidade Federal do Paraná, Brasil
| | - Julio Cesar Peclat de Oliveira
- Sociedade Brasileira de Angiologia e de Cirurgia Vascular, Brasil; Universidade Federal do Estado do Rio de Janeiro, Brasil
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