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Lee J, Jang JY, Ahn CM, Lee SJ, Lee SH, Lee YJ, Hong SJ, Kim JS, Kim BK, Hong MK, Jang Y, Kim TH, Park HW, Lee JH, Park JH, Kim SH, Im E, Park SH, Choi D, Ko YG. Intravascular Ultrasound Predictors of 12-Month Patency Loss Following Drug-Coated Balloon Angioplasty for the Femoropopliteal Artery. Am J Cardiol 2025; 246:58-64. [PMID: 40154590 DOI: 10.1016/j.amjcard.2025.03.018] [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: 01/23/2025] [Revised: 02/27/2025] [Accepted: 03/17/2025] [Indexed: 04/01/2025]
Abstract
Intravascular ultrasound (IVUS) has been shown to improve outcomes of drug-coated balloon (DCB) angioplasty for treatment of femoropopliteal artery (FPA) disease. However, the optimal IVUS criteria for achieving improved outcomes of DCB angioplasty for FPA disease remain uncertain. The study aimed to identify IVUS predictors for loss of patency at 12 months after DCB angioplasty for FPA disease. After excluding one patient due to insufficient IVUS imaging data, 98 patients in the IVUS-guidance group of the IVUS-DCB trial were included in the analysis. IVUS parameters predicting loss of patency at 12 months and their optimal cut-off values were investigated. Among the 98 patients who underwent IVUS-guided FPA intervention, 16 patients (16.3%) lost primary patency within 12 months. End-stage renal disease on hemodialysis and, bailout stenting, postprocedural dissection length >50% were independent procedural predictors for 12-month patency loss. Receiver operating characteristic (ROC) curve demonstrated that postprocedural minimal lumen area (MLA) ≥ 11.6 mm2 (area under the ROC curve: 0.685, 95% CI: 0.513 to 0.857) as the optimal cut-off value for sustained primary patency. In survival analysis, patients with MLA ≥ 11.6 mm2 had a hazard ratio of 0.27 (95% CI: 0.09 to 0.80, p-value = 0.019, risk difference: 19.8) for lower risk of patency loss. A postprocedural MLA ≥11.6 mm2 was an independent IVUS predictor for sustained primary patency after DCB angioplasty in patients with FPA disease. Our findings suggest that lesion optimization and achieving sufficient lumen area under IVUS guidance during DCB angioplasty are crucial for maintaining target vessel patency.
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Affiliation(s)
- Jaeoh Lee
- Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea
| | - Ji Yong Jang
- National Health Insurance Service Ilsan Hospital, Goyang, Republic of Korea
| | - Chul-Min Ahn
- Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea
| | - Seung-Jun Lee
- Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea
| | - Sang-Hyup Lee
- Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea
| | - Yong-Joon Lee
- Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea
| | - Sung-Jin Hong
- Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea
| | - Jung-Sun Kim
- Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea
| | - Byeong-Keuk Kim
- Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea
| | - Myeong-Ki Hong
- Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea
| | - Yangsoo Jang
- Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea
| | - Tae-Hoon Kim
- Division of Cardiology, Hanil General Hospital, Seoul, Republic of Korea; Division of Cardiology Cardiovascular Center, Bucheon Sejong Hospital, Bucheon, Republic of Korea
| | - Ha-Wook Park
- Division of Cardiology Cardiovascular Center, Bucheon Sejong Hospital, Bucheon, Republic of Korea
| | - Jae-Hwan Lee
- Division of Cardiology, Chungnam National University Sejong Hospital, Sejong, Republic of Korea; Division of Cardiology, Chungnam National University Hospital, Daejeon, Republic of Korea
| | - Jae-Hyeong Park
- Division of Cardiology, Chungnam National University Hospital, Daejeon, Republic of Korea
| | - Su Hong Kim
- Division of Cardiology, Busan Veterans Hospital, Busan, Republic of Korea
| | - Eui Im
- Division of Cardiology, Yongin Severance Hospital, Yongin, Republic of Korea
| | - Sang-Ho Park
- Cardiology Department, Soonchunhyang University Cheonan Hospital, Cheonan, Republic of Korea
| | - Donghoon Choi
- Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea
| | - Young-Guk Ko
- Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea.
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Tannu M, Jones WS, Swaminathan RV, Rymer JA, Gutierrez JA. Femoropopliteal Endovascular Intervention: A Review of the Current Landscape. Circ Cardiovasc Interv 2025; 18:e014024. [PMID: 40276857 DOI: 10.1161/circinterventions.124.014024] [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: 07/29/2024] [Revised: 02/18/2025] [Accepted: 03/17/2025] [Indexed: 04/26/2025]
Abstract
Superficial femoral artery disease poses significant challenges in patients with peripheral artery disease due to its unique anatomic and physiological characteristics. While conservative measures remain the initial approach for chronic, stable symptoms, endovascular therapies have gained prominence due to their minimally invasive nature, expedited recovery times, and preservation of future treatment options when performed correctly. Options for endovascular interventions include balloon angioplasty (percutaneous transluminal angioplasty [standard], drug-coated balloon), stenting (bare metal, drug-eluting, covered stents), with or without adjunct therapy (atherectomy or intravascular lithotripsy). Randomized controlled trials have demonstrated superior outcomes with drug-coated balloons and drug-eluting stents over bare metal stents or percutaneous transluminal angioplasty alone, particularly in long, heavily calcified lesions. However, challenges such as in-stent restenosis, stent fracture, and in-stent thrombosis persist, driving ongoing innovation in device technology and drug formulations on devices. Emerging therapies such as bioresorbable scaffolds and percutaneous bypass devices offer promising alternatives. Further research is needed to refine treatment strategies, minimize risks, and optimize outcomes.
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Affiliation(s)
- Manasi Tannu
- Division of Cardiology, Duke University Health System, Durham, NC (M.T., W.S.J., R.V.S., J.A.R., J.A.G.)
- Duke Clinical Research Institute, Durham, NC (M.T., W.S.J., J.A.R.)
| | - W Schuyler Jones
- Division of Cardiology, Duke University Health System, Durham, NC (M.T., W.S.J., R.V.S., J.A.R., J.A.G.)
- Duke Clinical Research Institute, Durham, NC (M.T., W.S.J., J.A.R.)
| | - Rajesh V Swaminathan
- Division of Cardiology, Duke University Health System, Durham, NC (M.T., W.S.J., R.V.S., J.A.R., J.A.G.)
- Durham VA Medical Center, Durham, NC (R.V.S., J.A.G.)
| | - Jennifer A Rymer
- Division of Cardiology, Duke University Health System, Durham, NC (M.T., W.S.J., R.V.S., J.A.R., J.A.G.)
- Duke Clinical Research Institute, Durham, NC (M.T., W.S.J., J.A.R.)
| | - J Antonio Gutierrez
- Division of Cardiology, Duke University Health System, Durham, NC (M.T., W.S.J., R.V.S., J.A.R., J.A.G.)
- Durham VA Medical Center, Durham, NC (R.V.S., J.A.G.)
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Wang Y, Li K, Shao J, Lai Z, Xie Y, Kong D, Liu B. Two year comparative outcomes of drug coated balloons in long versus short femoropopliteal lesions. Sci Rep 2025; 15:14165. [PMID: 40269197 PMCID: PMC12019180 DOI: 10.1038/s41598-025-98773-8] [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: 08/07/2024] [Accepted: 04/15/2025] [Indexed: 04/25/2025] Open
Abstract
While the efficacy and safety of drug-coated balloons (DCBs) for treating short femoropopliteal lesions are well-established, evidence on long-term outcomes for long lesions remains limited. This study aims to compare the 2-year clinical outcomes of DCB angioplasty between long and short femoropopliteal lesions and identify risk factors for patency loss. This real-world and single-center cohort study included 234 patients with de novo stenosis or restenosis or occlusion of the femoropopliteal arteries (115 long lesions > 15 cm, 141 short lesions ≤ 15 cm) who underwent successful DCB treatment from January 2019 to December 2021 at Peking Union Medical College Hospital. The primary safety endpoint was defined as freedom from major adverse events (death, target limb amputation or thrombosis). The primary effectiveness endpoint was defined as 2-year primary patency, defined as freedom from both clinically driven target lesion revascularization (CD-TLR) and restenosis. Primary patency was significantly lower in long lesions (48.3% vs. 62.5%, p = 0.005), while freedom from CD-TLR rate showed no difference (83.6% vs. 87.4%, p = 0.25). Long lesions exhibited higher rates of occlusions (p < 0.001), in-stent restenosis (p = 0.025), and advanced ischemia (Rutherford Clinical Category (RCC) 4-6, p = 0.038). Multivariate analysis identified lesion length > 15 cm (p = 0.017) and RCC 4-6 (p = 0.026) as independent predictors of patency loss. Within the long lesion subgroup, only RCC 4-6 maintained prognostic significance (p = 0.027), and no significant predictors emerged in the short lesion group. Major adverse events occurred in 12.4% of patients, predominantly in long lesions with severe comorbidities. While DCB angioplasty achieved acceptable 2-year safety outcomes, long femoropopliteal lesions (> 15 cm) demonstrated significantly inferior primary patency compared to short lesions (48.3% vs. 62.5%, p = 0.005). Advanced ischemia (RCC 4-6) is a risk factor for patency loss.
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Affiliation(s)
- Yuru Wang
- Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China
- Department of Vascular Surgery, Peking Union Medical College Hospital, ShuaiFuYuan 1 st, DongCheng-Qu, Beijing, 100730, China
| | - Kang Li
- Department of Vascular Surgery, Peking Union Medical College Hospital, ShuaiFuYuan 1 st, DongCheng-Qu, Beijing, 100730, China
| | - Jiang Shao
- Department of Vascular Surgery, Peking Union Medical College Hospital, ShuaiFuYuan 1 st, DongCheng-Qu, Beijing, 100730, China
| | - Zhichao Lai
- Department of Vascular Surgery, Peking Union Medical College Hospital, ShuaiFuYuan 1 st, DongCheng-Qu, Beijing, 100730, China
| | - Yiyun Xie
- Department of Vascular Surgery, Peking Union Medical College Hospital, ShuaiFuYuan 1 st, DongCheng-Qu, Beijing, 100730, China
| | - Deqiang Kong
- Department of Vascular Surgery, Peking Union Medical College Hospital, ShuaiFuYuan 1 st, DongCheng-Qu, Beijing, 100730, China
| | - Bao Liu
- Department of Vascular Surgery, Peking Union Medical College Hospital, ShuaiFuYuan 1 st, DongCheng-Qu, Beijing, 100730, China.
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Giannopoulos S, Volteas P, Koudounas G, Virvilis D, Labropoulos N. Contemporary Femoropopliteal Stents: Reporting Gaps of Randomized Trials. Ann Vasc Surg 2025; 118:68-82. [PMID: 40254154 DOI: 10.1016/j.avsg.2025.04.110] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/15/2024] [Revised: 04/07/2025] [Accepted: 04/07/2025] [Indexed: 04/22/2025]
Abstract
BACKGROUND Endovascular literature has been under scrutiny due to perceived poor-quality data. This has been attributed to multiple reasons, including but not limited to smaller sample size, absence of standardization of reporting methodology and investigational treatment protocols, and limited funding resources. The goal of the current study was to review the design of randomized controlled trials investigating contemporary stents for the femoropopliteal segment, with reported >70-80% primary efficacy rate and address issues with their respective reporting methodology. METHODS This systematic review and meta-analysis was conducted according to the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines (CRD42024508602). The Medline (PubMed), Scopus, and Cochrane databases were reviewed for randomized controlled trials reporting on the safety and efficacy of femoropopliteal Zilver PTX, Eluvia, Viabahn, and Supera stents through February 2024. Data were collected regarding baseline, lesion, and procedural characteristics and postprocedural outcomes. RESULTS 17 articles were identified, presenting the results of 11 trials. 80% of the studied individuals were males having intermittent claudication (overall 81%; Rutherford class (RC) 2; 8 trials; 29%; RC 3; 8 trials; 46%). The mean preprocedural ankle-brachial index (ABI) was 0.64 (0.56-0.72). Details about run-off vessels, inflow or outflow disease treatment, and antithrombotic regimen compliance were missing in most papers. Only 3 trials had long-term data (≥36 months). Critical information about postprocedural and during follow-up ABI values, amputation rates, and stent fracture rates were not reported in 6, 5, and 13 articles, respectively. The definition of the primary efficacy endpoint was similar in all studies, although the peak systolic velocity (PSV) ratio cutoff that was used ranged from 2.0 to 2.5 (1 study: 2.5; 6 studies: 2.4; 5 studies: 2.0). Post-treatment clinical benefit was often defined as improvement in RC and/or ABI, although individual values were not always provided. CONCLUSION The studies exhibited considerable variation in assessment of outcomes and reporting methodology. Standardized reporting methods for lesion or procedural characteristics and post-treatment clinical benefit need to be established to facilitate translation of clinical trials results to actual practice.
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Affiliation(s)
- Stefanos Giannopoulos
- Division of Vascular and Endovascular Surgery, Department of Surgery, Stony Brook University Hospital, Stony Brook, NY
| | - Panagiotis Volteas
- Division of Vascular and Endovascular Surgery, Department of Surgery, Stony Brook University Hospital, Stony Brook, NY
| | - George Koudounas
- Vascular Unit, 5th Department of Surgery, Aristotle University Medical School, Hippokratio Hospital, Thessaloniki, Greece
| | - Dimitrios Virvilis
- Department of Vascular and Endovascular Surgery, St Francis Hospital & Heart Center, Roslyn, NY
| | - Nicos Labropoulos
- Division of Vascular and Endovascular Surgery, Department of Surgery, Stony Brook University Hospital, Stony Brook, NY.
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Johnson AP, Swaminathan RV, Minc SD, Gutierrez JA. Femoropopliteal Interventions for Peripheral Artery Disease: A Review of Current Evidence and Future Directions. Interv Cardiol Clin 2025; 14:243-256. [PMID: 40049851 DOI: 10.1016/j.iccl.2024.11.010] [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: 05/13/2025]
Abstract
The femoropopliteal segment is a common anatomic location for peripheral artery disease. The clinical presentation of occlusive disease of the femoropopliteal segment can range from symptomatic or severe claudication if in isolation, or acute or chornic limb threatening ischemia often in the setting of multilevel disease. Patients can be treated with various therapies to improve symptoms and restore perfusion, including medical, exercise, endovascular, and open surgical therapies. The current literature is rapidly evolving on the best management algorithms and strategies based on patient presentation, severity of occlusive disease, and desired therapy goals. This paper summarizes current literature on available medical, endovascular, and surgical therapies for treating peripheral artery occlusive disease of the femoropopliteal segment.
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Affiliation(s)
- Adam P Johnson
- Department of Surgery, Division of Vascular and Endovascular Surgery, Duke University Health System, Durham, NC, USA; Durham Veterans Administration Medical Center, Durham, NC, USA.
| | - Rajesh V Swaminathan
- Durham Veterans Administration Medical Center, Durham, NC, USA; Department of Medicine, Division of Cardiology, Duke University Health System, 508 Fulton Street, Durham, NC 27705, USA; Duke Clinical Research Institute, Durham, NC, USA
| | - Samantha D Minc
- Department of Surgery, Division of Vascular and Endovascular Surgery, Duke University Health System, Durham, NC, USA; Department of Surgery, Division of Vascular Surgery, West Virginia University School of Medicine, Morgantown, WV, USA
| | - Jorge Antonio Gutierrez
- Durham Veterans Administration Medical Center, Durham, NC, USA; Department of Medicine, Division of Cardiology, Duke University Health System, 508 Fulton Street, Durham, NC 27705, USA
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Zhang R, Jiang CY, Cai TH, He JF, Chen K, Zhan TH. Short-term therapeutic efficacy analysis of drug-coated balloon combined with chocolate balloon for the treatment of femoropopliteal artery lesions. Front Surg 2025; 12:1419127. [PMID: 40225114 PMCID: PMC11986640 DOI: 10.3389/fsurg.2025.1419127] [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: 04/17/2024] [Accepted: 03/10/2025] [Indexed: 04/15/2025] Open
Abstract
Background To report our experience of short-term results of drug-coated balloon (DCB) combined with chocolate balloon in the treatment of femoropopliteal artery lesions. Methods From June 2021 to December 2022, patients with femoropopliteal artery lesions (Rutherford classification 2-6) who underwent DCB combined with Chocolate PTA balloon catheter treatment were included. Clinical data of the patients were collected, and follow-up was conducted at 3, 6, and 12 months. The primary patency rate and the freedom from clinically-driven target lesion revascularization (f-TLR) rate were calculated by Kaplan-Meier survival curves. Results This study included a total of 43 patients (mean age 72.84 ± 10.19 years, male proportion 67.4%) with 47 lesions. Among them, 17 lesions (36.2%) presented severe stenosis with an average lesion length of 110.41 ± 47.67 mm. Thirty lesions (63.8%) were identified as chronic total occlusions (CTO), with an average occlusion length of 104.13 ± 61.12 mm. The Kaplan-Meier survival curve estimated a primary patency rate of 87.2% at 6 months and 78.7% at 12 months. The f-TLR rate at 12 months was 85.1%, estimated by Kaplan-Meier survival curve. The mean ankle-brachial index (ABI) increased from 0.53 ± 0.12 before the surgery to 0.87 ± 0.12 at 12 months postoperatively, and this difference was statistically significant (p < 0.001). A total of 91.5% of patients (43/47) showed a decrease in Rutherford classification at 12 months postoperatively. The proportion of patients with Rutherford class 4-6 decreased from 70.2% (33/47) preoperatively to 4.3% (2/47) at 12 months postoperatively, and this difference was statistically significant (p < 0.001). Among the limbs, 34 (72.3%) experienced dissection during the surgery, with 29 cases classified as type B or lower dissection and 5 cases classified as type C or higher (severe dissection) (10.6%). Two limbs (4.3%) required the use of salvage stents. There were no procedure- or device-related deaths within the 12-month period. Twelve limbs (25.5%) underwent minor amputations (toe amputations). Conclusion The combination of DCB and chocolate balloon angioplasty has achieved satisfactory patency rates and f-TLR results in 1-year follow-up for the treatment of femoropopliteal artery lesions. However, further confirmation of these findings is needed through multicenter data and long-term follow-up results.
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Affiliation(s)
| | | | | | | | | | - Teng Hui Zhan
- Department of Vascular Surgery & Interventional Treatment, Fujian Maternity and Child Health Hospital, College of Clinical Medicine for Obstetrics & Gynecology and Pediatrics, Fujian Medical University, Fuzhou, China
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Joh JH. Algorithm for the Revascularization of Infrainguinal Arterial Disease. Vasc Specialist Int 2025; 41:6. [PMID: 40097243 PMCID: PMC11913610 DOI: 10.5758/vsi.240113] [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: 12/09/2024] [Revised: 02/09/2025] [Accepted: 02/21/2025] [Indexed: 03/19/2025] Open
Abstract
Peripheral artery disease (PAD) is a common vascular condition affecting over 200 million people worldwide. It is primarily characterized by stenosis or occlusion of peripheral arteries due to atherosclerosis. The infrainguinal segment is frequently involved in PAD, making revascularization decisions for infrainguinal arterial disease (IAD) complex. Multiple factors, including the patient's condition and anatomical characteristics, must be carefully considered when determining the optimal treatment approach. Once these factors are evaluated, the first revascularization strategy is selected from among open, endovascular, or hybrid modalities, based on high-level evidence. Endovascular therapy is widely accepted as the standard treatment for simple IAD, with balloon angioplasty and stenting being the commonly used techniques. However, advancements in endovascular techniques have enabled the treatment of increasingly complex lesions. Additionally, drug-based technologies have enhanced the durability of treatment outcomes, including improvements in primary patency rates and freedom from target lesion revascularization. Similar to surgical endarterectomy, percutaneous atherectomy has been developed to remove atherosclerotic plaques and mitigate intimal calcification. The purpose of this paper is to present an algorithm for revascularization of IAD through a comprehensive review of studies comparing the outcomes of various treatment modalities.
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Affiliation(s)
- Jin Hyun Joh
- Department of Surgery, Kyung Hee University Hospital at Gangdong, Kyung Hee University School of Medicine, Seoul, Korea
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Korosoglou G, Schmidt A, Lichtenberg M, Malyar N, Stavroulakis K, Reinecke H, Grözinger G, Patrone L, Varcoe RL, Soukas PA, Böckler D, Behrendt CA, Secemsky EA, Zeller T, Blessing E, Langhoff R, Rammos C. Global Algorithm for the Endovascular Treatment of Chronic Femoropopliteal Lesions: An Interdisciplinary Expert Opinion Statement. JACC Cardiovasc Interv 2025; 18:545-557. [PMID: 40074516 DOI: 10.1016/j.jcin.2024.11.038] [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: 01/24/2024] [Revised: 09/17/2024] [Accepted: 11/05/2024] [Indexed: 03/14/2025]
Abstract
A global treatment algorithm was developed for the endovascular revascularization of femoropopliteal lesions and chronic total occlusions, aiming toward a more standardized approach to endovascular treatment in patients with peripheral artery disease. The following steps are proposed. 1) Evaluation of lesion morphology based on preprocedural imaging by Duplex sonography and intravenous ultrasound for selection of lesion preparation tools. Lesion characteristics are mainly defined by calcification, lesion length, and the presence of total occlusion and in-stent restenosis. 2) Selection of vessel preparation strategies, which encompass plain old balloon angioplasty, atherectomy, thrombectomy, intravascular lithotripsy and specialty balloons, or a combination of the preceding, based on lesion and patient-specific characteristics. In addition, a Delphi consensus was applied for the appropriateness of lesion preparation strategies, depending on lesion anatomy, length, plaque morphology, and subintimal versus intraluminal guidewire crossing. 3) Definitive lesion treatment strategies using drug-coated balloons, bare-metal stents, drug-eluting stents, and/or covered stents or a combination. By establishing this treatment algorithm in routine practice, improvements in vessel- and patient-specific outcomes are anticipated, which will be further enhanced by continuous collaboration among experts from different countries and disciplines and by randomized controlled trials.
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Affiliation(s)
| | - Andrej Schmidt
- Division of Angiology, University Hospital Leipzig, Leipzig, Germany
| | | | - Nasser Malyar
- Department of Cardiology I-Coronary and Peripheral Vascular Disease, Heart Failure, University Hospital Muenster, Muenster, Germany
| | - Konstantinos Stavroulakis
- Department of Vascular Surgery, Ludwig-Maximilians-University Hospital Munich, Munich, Germany; Mathias Spital Rheine, Department of Vascular and Endovascular Surgery, Rheine, Germany
| | - Holger Reinecke
- Department of Cardiology I-Coronary and Peripheral Vascular Disease, Heart Failure, University Hospital Muenster, Muenster, Germany
| | - Gerd Grözinger
- University of Tübingen, Department of Radiology, Tübingen, Germany
| | - Lorenzo Patrone
- Vascular and Endovascular Surgery Unit, San Giovanni di Dio Hospital, Florence, Italy
| | - Ramon L Varcoe
- University of New South Wales and the Department of Surgery, Prince of Wales Hospital, Sydney, New South Wales, Australia
| | - Peter A Soukas
- Brown University Health Cardiovascular Institute, Providence, Rhode Island, USA
| | - Dittmar Böckler
- Department of Vascular and Endovascular Surgery, University Hospital Heidelberg, Heidelberg, Germany
| | - Christian-Alexander Behrendt
- Department of Vascular and Endovascular Surgery, Asklepios Clinic Wandsbek, Asklepios Medical School, Hamburg, Germany
| | - Eric A Secemsky
- Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA; Harvard Medical School, Boston, Massachusetts, USA; Division of Cardiology, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA
| | - Thomas Zeller
- Department of Interventional Angiology, University Hospital Freiburg/Bad Krozingen, Bad Krozingen, Germany
| | - Erwin Blessing
- University Heart and Vascular Center, Department of Angiology, University Hospital Hamburg-Eppendorf, Hamburg, Germany
| | - Ralf Langhoff
- Brandenburg Medical School Theodor Fontane, Campus, Clinic Brandenburg, Brandenburg an der Havel, Berlin, Germany
| | - Christos Rammos
- Department of Cardiology and Vascular Medicine, West German Heart and Vascular Center, University of Duisburg-Essen, Essen, Germany
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9
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Rammos C, Rassaf T, Korosoglou G. [Peripheral artery disease II: femoropopliteal lesions]. INNERE MEDIZIN (HEIDELBERG, GERMANY) 2025; 66:258-267. [PMID: 39961833 DOI: 10.1007/s00108-025-01858-9] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Accepted: 01/29/2025] [Indexed: 03/06/2025]
Abstract
The endovascular treatment of the femoropopliteal segment is the most frequent revascularization option in patients with peripheral arterial occlusive disease (PAOD); however, the plain old balloon angioplasty has limitations, especially in complex and calcified lesions, and can lead to dissections and recoil. In order to improve the technical success and the efficacy of the endovascular treatment in complex, sometimes severely calcified or thrombotic lesions or also in lesions in mobile segments, a lesion preparation strategy before the actual lesion treatment is frequently applied. Lesion preparation methods include atherectomy, thrombectomy or intravascular lithotripsy. Through lesion preparation plaques and/or organized thrombi can be minimally invasively removed or calcium deposits can be even fragmented with low threshold barotrauma, without damaging the vessel wall. Subsequently, the definitive treatment of the lesion can be carried out using drug-coated balloons (DCB), bare metal stents (BMS), drug-eluting stents (DES) or a combination of these. Due to the heterogeneity of patient and lesion characteristics, no 'one fits all' strategy is so far available; however, the choice of the appropriate instruments should be carried out based on the patient and lesion characteristics present, whereby for the lesion-specific parameters the extent of the morphology and underlying pathology plays an important role.
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Affiliation(s)
- Christos Rammos
- Department of Cardiology and Vascular Medicine, West German Heart and Vascular Center, University of Duisburg-Essen, Duisburg-Essen, Deutschland
| | - Tienush Rassaf
- Department of Cardiology and Vascular Medicine, West German Heart and Vascular Center, University of Duisburg-Essen, Duisburg-Essen, Deutschland
| | - Grigorios Korosoglou
- Departments of Cardiology & Angiology, GRN Hospitals Weinheim & Eberbach, Roentgenstraße 1, 69469, Weinheim, Deutschland.
- Cardiovascular Imaging Center, Hector Foundation, Weinheim, Deutschland.
- Departments of Cardiology & Angiology, GRN Hospital Eberbach, Scheuerbergstraße 3, 69412, Eberbach, Deutschland.
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Schwartz AW, Shah Y, Huang H, Nathan A, Fanaroff AC, Giri JS, Parikh SA, Lansky AJ, Shah T. Comparison of Endovascular Interventions for the Treatment of Superficial Femoral Artery Disease: A Network Meta-analysis. JOURNAL OF THE SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY & INTERVENTIONS 2025; 4:102432. [PMID: 40061407 PMCID: PMC11887560 DOI: 10.1016/j.jscai.2024.102432] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Subscribe] [Scholar Register] [Received: 05/30/2024] [Revised: 09/24/2024] [Accepted: 10/08/2024] [Indexed: 05/02/2025]
Abstract
Background To understand the relative safety and efficacy of endovascular treatment modalities used for superficial femoral artery (SFA) disease, we performed a network meta-analysis to compare outcomes between percutaneous transluminal angioplasty (PTA), atherectomy (A), bare metal stent (BMS), brachytherapy/radiotherapy, covered stent graft (CSG), cutting balloon angioplasty (CBA), drug-coated balloon (DCB), drug-eluting stent (DES), and intravascular lithotripsy (L). Methods We performed a systematic literature search of PubMed from January 2000 to January 2023 to identify randomized trials comparing endovascular interventions for the treatment of SFA disease. The primary end points were technical success and 12-month primary patency. Results In total, 57 studies (9089 patients) were included. The mean age of the included patients was 68.4 years, 41.4% had diabetes, 18.3% had critical limb ischemia, and 81.3% had de novo lesions. A mean of 1.2 lesions were treated per patient. Technical success was superior for CSG, BMS, and A+DCB compared with PTA, while A+DCB and CSG were superior to DCB. All interventions except brachytherapy alone had superior primary patency compared with PTA. There were no significant differences in 12-month mortality or major amputation. All interventions except L+DCB, PTA+A, and CBA were superior to PTA regarding target lesion revascularization, while only DCB, DES, and BMS were better than PTA at improving Rutherford classification. Conclusions In SFA disease, PTA alone is mostly inferior to other endovascular techniques. This comparison of other endovascular techniques will be valuable for endovascular device selection in the treatment of SFA disease.
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Affiliation(s)
- Andrew W. Schwartz
- Yale Cardiovascular Research Group, Division of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut
| | - Yousuf Shah
- Department of Medicine, University of Rochester School of Medicine and Dentistry, Rochester, New York
| | - Haocheng Huang
- Yale Cardiovascular Research Group, Division of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut
| | - Ashwin Nathan
- Cardiovascular Medicine Division, The Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania
| | - Alexander C. Fanaroff
- Cardiovascular Medicine Division, The Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania
| | - Jay S. Giri
- Cardiovascular Medicine Division, The Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania
| | - Sahil A. Parikh
- Division of Cardiology, Columbia University Irving Medical Center, New York, New York
| | - Alexandra J. Lansky
- Yale Cardiovascular Research Group, Division of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut
| | - Tayyab Shah
- Yale Cardiovascular Research Group, Division of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut
- Cardiovascular Medicine Division, The Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania
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11
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Hao J, Wang D, Zhao Y, Zhu Y, Tinley T, Liu W, Li W, Wang C, Wang Y. The Consideration of Appropriate Surrogate Endpoint in Premarket Clinical Trials of Drug-Coated Balloon Catheter for the Treatment of Femoropopliteal Artery Stenosis. J Endovasc Ther 2024:15266028241300861. [PMID: 39644164 DOI: 10.1177/15266028241300861] [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: 12/09/2024]
Abstract
PURPOSE Most clinical trials of drug-coated balloon (DCB) for the treatment of femoropopliteal artery stenosis chose 12-month primary patency rate (PPR) or 6-month late lumen loss (LLL) as the primary endpoint. It is still debatable whether 6-month LLL can be served as an appropriate surrogate endpoint for 12-month PPR. This study aimed to identify whether LLL can serve as an appropriate surrogate endpoint in peripheral DCB clinical trials, and shed light on the selection of primary outcome for subsequent confirmatory clinical trials of DCB in the treatment of femoropopliteal artery stenosis. MATERIALS AND METHODS The linear regression model was used to evaluate the correlation between 12-month PPR and 6-month LLL. Pooled standardized mean differences (SMDs) and relative gain between the DCB and plain old balloon angioplasty (POBA) group were computed to assess the consistency and surrogacy, using fixed or random effect model as appropriate. The coefficient of variation (CV) was calculated for both endpoints to compare their degree of variation overall and at study level. RESULTS A total of 34 studies are eligible for this study. A significant negative linear correlation was found between 12-month PPR and 6-month LLL (R2=0.67, slope=-0.309, p=0.007). The SMD (DCB-POBA) of LLL and PPR was -0.76 (95% confidence interval [CI]: -0.98, -0.54), and 0.59 (95% CI: 0.46, 0.72) (p=0.18). The pooled relative gain of PPR (43%, 95% CI: 35%, 50%) was significantly lower than that of LLL (72%, 95% CI: 61%, 84%) (p<0.001). Coefficient of variation of LLL was larger than that of PPR overall in DCB and POBA groups. CONCLUSION Although a significant moderate correlation was observed between 12-month PPR and 6-month LLL, PPR shows more conservative and robust than LLL, which may exaggerate clinical benefits. Late lumen loss should be used discreetly depending on different situations and clinical benefits for patients. CLINICAL IMPACT This study addresses the critical issue of primary endpoint selection in clinical trials of drug-coated balloon for femoropopliteal artery stenosis. By elucidating the moderate correlation between 6-month late lumen loss (LLL) and 12-month primary patency rate (PPR), the findings underscore the limitations of LLL as a surrogate endpoint due to its variability and potential to overstate clinical benefits. The study advocates for the use of 12-month PPR as a more robust and conservative endpoint in pivotal trials, particularly for novel devices. These findings provide clinicians with a nuanced understanding of outcome measures, promoting evidence-based decision-making and regulatory alignment to ensure patient benefits in vascular interventions.
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Affiliation(s)
- Jun Hao
- Medical Research and Biometrics Center, National Clinical Research Center for Cardiovascular Diseases, National Center for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China
- Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK
- Institute for Global Health, University College London, London, UK
| | - Duoer Wang
- Medical Research and Biometrics Center, National Clinical Research Center for Cardiovascular Diseases, National Center for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China
| | - Yanyan Zhao
- Medical Research and Biometrics Center, National Clinical Research Center for Cardiovascular Diseases, National Center for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China
| | - Yingxuan Zhu
- Medical Research and Biometrics Center, National Clinical Research Center for Cardiovascular Diseases, National Center for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China
| | - Tenzin Tinley
- Medical Research and Biometrics Center, National Clinical Research Center for Cardiovascular Diseases, National Center for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China
| | - Weida Liu
- Medical Research Center, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China
| | - Wei Li
- Medical Research and Biometrics Center, National Clinical Research Center for Cardiovascular Diseases, National Center for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China
| | - Chuangshi Wang
- Medical Research and Biometrics Center, National Clinical Research Center for Cardiovascular Diseases, National Center for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China
- Department of Structural Heart Disease, National Center for Cardiovascular Disease, Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China
| | - Yang Wang
- Medical Research and Biometrics Center, National Clinical Research Center for Cardiovascular Diseases, National Center for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China
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12
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Chen J, Tang Y, Shen Z, Wang W, Hou J, Li J, Chen B, Mei Y, Liu S, Zhang L, Lu S. Predicting and Analyzing Restenosis Risk after Endovascular Treatment in Lower Extremity Arterial Disease: Development and Assessment of a Predictive Nomogram. J Endovasc Ther 2024; 31:1140-1149. [PMID: 36891634 DOI: 10.1177/15266028231158294] [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: 03/10/2023]
Abstract
PURPOSE This study aimed to develop and internally validate nomograms for predicting restenosis after endovascular treatment of lower extremity arterial diseases. MATERIALS AND METHODS A total of 181 hospitalized patients with lower extremity arterial disease diagnosed for the first time between 2018 and 2019 were retrospectively collected. Patients were randomly divided into a primary cohort (n=127) and a validation cohort (n=54) at a ratio of 7:3. The least absolute shrinkage and selection operator (LASSO) regression was used to optimize the feature selection of the prediction model. Combined with the best characteristics of LASSO regression, the prediction model was established by multivariate Cox regression analysis. The predictive models' identification, calibration, and clinical practicability were evaluated by the C index, calibration curve, and decision curve. The prognosis of patients with different grades was compared by survival analysis. Internal validation of the model used data from the validation cohort. RESULTS The predictive factors included in the nomogram were lesion site, use of antiplatelet drugs, application of drug coating technology, calibration, coronary heart disease, and international normalized ratio (INR). The prediction model demonstrated good calibration ability, and the C index was 0.762 (95% confidence interval: 0.691-0.823). The C index of the validation cohort was 0.864 (95% confidence interval: 0.801-0.927), which also showed good calibration ability. The decision curve shows that when the threshold probability of the prediction model is more significant than 2.5%, the patients benefit significantly from our prediction model, and the maximum net benefit rate is 30.9%. Patients were graded according to the nomogram. Survival analysis found that there was a significant difference in the postoperative primary patency rate between patients of different classifications (log-rank p<0.001) in both the primary cohort and the validation cohort. CONCLUSION We developed a nomogram to predict the risk of target vessel restenosis after endovascular treatment by considering information on lesion site, postoperative antiplatelet drugs, calcification, coronary heart disease, drug coating technology, and INR. CLINICAL IMPACT Clinicians can grade patients after endovascular procedure according to the scores of the nomograms and apply intervention measures of different intensities for people at different risk levels. During the follow-up process, an individualized follow-up plan can be further formulated according to the risk classification. Identifying and analyzing risk factors is essential for making appropriate clinical decisions to prevent restenosis.
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Affiliation(s)
- Jinxing Chen
- Department of Vascular Surgery, The First Affiliated Hospital of Xi'an JiaoTong University, Xi'an, Shaanxi, P. R. China
| | - Yanan Tang
- Department of Vascular Surgery, The First Affiliated Hospital of Xi'an JiaoTong University, Xi'an, Shaanxi, P. R. China
| | - Zekun Shen
- Department of Vascular Surgery, The First Affiliated Hospital of Xi'an JiaoTong University, Xi'an, Shaanxi, P. R. China
| | - Weiyi Wang
- Department of Vascular Surgery, The First Affiliated Hospital of Xi'an JiaoTong University, Xi'an, Shaanxi, P. R. China
| | - Jiaxuan Hou
- Department of Vascular Surgery, The First Affiliated Hospital of Xi'an JiaoTong University, Xi'an, Shaanxi, P. R. China
| | - Jiayan Li
- Department of Vascular Surgery, The First Affiliated Hospital of Xi'an JiaoTong University, Xi'an, Shaanxi, P. R. China
| | - Bingyi Chen
- Department of Vascular Surgery, The First Affiliated Hospital of Xi'an JiaoTong University, Xi'an, Shaanxi, P. R. China
| | - Yifan Mei
- Department of Vascular Surgery, The First Affiliated Hospital of Xi'an JiaoTong University, Xi'an, Shaanxi, P. R. China
| | - Shuang Liu
- Department of Vascular Surgery, The First Affiliated Hospital of Xi'an JiaoTong University, Xi'an, Shaanxi, P. R. China
| | - Liwei Zhang
- Department of Vascular Surgery, The First Affiliated Hospital of Xi'an JiaoTong University, Xi'an, Shaanxi, P. R. China
| | - Shaoying Lu
- Department of Vascular Surgery, The First Affiliated Hospital of Xi'an JiaoTong University, Xi'an, Shaanxi, P. R. China
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13
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El Khoury R, Asha A, Bystrom PV, Weiss R, Jacobs CE, Schwartz LB. In-stent restenosis. THE JOURNAL OF CARDIOVASCULAR SURGERY 2024; 65:439-453. [PMID: 39589276 DOI: 10.23736/s0021-9509.24.13199-0] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 11/27/2024]
Abstract
Endovascular arterial recanalization has become the mainstay therapy for peripheral arterial occlusive disease. Although immediate technical success is achieved in greater than 90% of cases, longer-term results continue to vary based on the clinical presentation, and the treated target lesion. In the current era, sustained patency can be expected following intervention in the carotid, coronary, renal, and iliac arteries. However, maintaining patency in the femoropopliteal and tibial arteries continues to be present a significant challenge. Endovascular intervention in the peripheral arteries is met with heavy complex plaque burdens, multiple serial stenoses and occlusions, sluggish blood flow, low mean and oscillatory shear stress, and repetitive axial, radial and torsional deformation that hinder its outcomes. In order to maximize the longevity of endovascular intervention, its therapeutic armamentarium has developed to include vessel preparation, drug delivery, and arterial scaffolding. Nevertheless, in the aggregate of real-world clinical practice, recurrence of stenosis still complicates up to 50% of all infrainguinal endovascular procedures after only one year. Unfortunately, this timeline is often insufficient to reliably address lifestyle limiting symptoms, heal a wound, or save a threatened extremity. The purpose of this review is to discuss the pathophysiology, incidence, risk factors, morphology and treatment of restenosis following peripheral endovascular intervention.
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Affiliation(s)
- Rym El Khoury
- Division of Vascular Surgery, Department of Surgery, Endeavor Health/NorthShore University Health System, Evanston, IL, USA -
| | - Ahmad Asha
- Department of Surgery, Advocate Lutheran General Hospital, Park Ridge, IL, USA
| | - Philip V Bystrom
- Department of Surgery, Advocate Lutheran General Hospital, Park Ridge, IL, USA
| | - Robert Weiss
- Department of Surgery, Advocate Lutheran General Hospital, Park Ridge, IL, USA
| | - Chad E Jacobs
- Department of Surgery, Advocate Lutheran General Hospital, Park Ridge, IL, USA
| | - Lewis B Schwartz
- Department of Surgery, Advocate Lutheran General Hospital, Park Ridge, IL, USA
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14
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Ogata K, Nishihira K, Asano Y, Honda Y, Yamamoto K, Emori H, Kadooka K, Kimura T, Kudo T, Ashikaga K, Shibata Y, Tsujita K. Clinical Comparison of Drug-Coated Balloon and Drug-Eluting Stent for Femoropopliteal Lesions in Chronic Limb-Threatening Ischemia With Wounds. Circ J 2024; 88:1647-1655. [PMID: 39069494 DOI: 10.1253/circj.cj-24-0176] [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] [Indexed: 07/30/2024]
Abstract
BACKGROUND Endovascular therapy (EVT) with devices such as drug-coated balloons (DCBs) and drug-eluting stents (DESs) for atherosclerotic disease in the femoropopliteal (FP) artery has been established. However, EVT using drug-based devices for chronic limb-threatening ischemia (CLTI) remains challenging. The optimal device for FP lesions in patients with CLTI remains unknown. This study compared the clinical efficacy of DCB and DES in patients with CLTI and FP lesions. METHODS AND RESULTS This retrospective single-center study included 539 consecutive patients (562 lesions) treated with EVT between January 2018 and December 2022; 166 patients with CLTI and Rutherford Class 5 or 6 wounds underwent EVT with DCB or DES. Clinical outcomes were compared between 53 pairs after propensity score matching. There were no significant differences between the DCB and DES groups in the incidence of complete wound healing without death or major amputation (84.8% vs. 80.2%, respectively; P=0.99), primary patency (69.4% vs. 75.6%, respectively; P=0.65), and freedom from target lesion revascularization at 1 year (78.6% vs. 78.0%, respectively; P=0.92). Multivariate analysis showed that complete wound healing at 1 year is negatively associated with hemodialysis and Wound, Ischemia, and foot Infection Stage 4, but positively associated with Global Limb Anatomic Staging System FP Grade 3 or 4. CONCLUSIONS No significant differences in clinical outcomes were found between DCB and DES for patients with CLTI and FP lesions.
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Affiliation(s)
- Kenji Ogata
- Department of Cardiology, Miyazaki Medical Association Hospital
- Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University
| | | | - Yuya Asano
- Department of Cardiology, Miyazaki Medical Association Hospital
| | - Yasuhiro Honda
- Department of Cardiology, Miyazaki Medical Association Hospital
| | | | - Hiroki Emori
- Department of Cardiology, Miyazaki Medical Association Hospital
| | - Kosuke Kadooka
- Department of Cardiology, Miyazaki Medical Association Hospital
| | | | - Takeaki Kudo
- Department of Cardiology, Miyazaki Medical Association Hospital
| | | | | | - Kenichi Tsujita
- Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University
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15
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Gouëffic Y, Brodmann M, Deloose K, Dubosq-Lebaz M, Nordanstig J. Drug-eluting devices for lower limb peripheral arterial disease. EUROINTERVENTION 2024; 20:e1136-e1153. [PMID: 39279515 PMCID: PMC11423351 DOI: 10.4244/eij-d-23-01080] [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: 12/18/2023] [Accepted: 06/06/2024] [Indexed: 09/18/2024]
Abstract
Peripheral arterial disease is the third leading cause of cardiovascular morbidity after coronary artery disease and stroke. Lower limb peripheral arterial disease commonly involves infrainguinal arteries, may impair walking ability (intermittent claudication) and may confer a significant risk of limb loss (chronic limb-threatening ischaemia), depending on the severity of ischaemia. Endovascular treatment has become the mainstay revascularisation option in both the femoropopliteal and the below-the-knee arterial segments. After crossing and preparing the lesion, treatment results in these arterial segments can be enhanced by using drug-coated devices (drug-eluting stents and drug-coated balloons) that mitigate the occurrence of restenosis. As for other medical devices, the use of drug-eluting devices is based on their demonstrated safety and efficacy profiles when applied in the distinct segments of the lower limb vasculature. In this state-of-the-art narrative review we provide an overview of the safety and efficacy of drug-coated devices when used in the femoropopliteal and below-the-knee arterial segments.
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Affiliation(s)
- Yann Gouëffic
- Service de chirurgie vasculaire et endovasculaire, Groupe Hospitalier Paris St Joseph, Paris, France
| | | | - Koen Deloose
- Department of Vascular Surgery, AZ Sint-Blasius Hospital Dendermonde, Dendermonde, Belgium
| | - Maxime Dubosq-Lebaz
- Vascular & endovascular surgery, Aortic Centre, Institut Coeur Poumon, CHU de Lille, Lille, France
| | - Joakim Nordanstig
- Institute of Medicine, Department of Molecular and Clinical Medicine, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
- Department of Vascular Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden
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16
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Yoon YH, Lee JH, Hwang WM, Park HW, Roh JH, Lee SJ, Ko YG, Ahn CM, Yu CW, Lee SW, Youn YJ, Park JK, Yoon CH, Rha SW, Min PK, Choi SH, Chae IH, Choi D, On Behalf OTKVI. Treatment extent of femoropopliteal disease and clinical outcomes following endovascular therapy. EUROINTERVENTION 2024; 20:e1154-e1162. [PMID: 39279516 PMCID: PMC11384224 DOI: 10.4244/eij-d-24-00037] [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] [Indexed: 09/18/2024]
Abstract
BACKGROUND Endovascular therapy (EVT) has become the preferred treatment modality for femoropopliteal disease. However, there is limited evidence regarding its procedural and clinical outcomes according to the affected area. AIMS The aim of this study is to investigate clinical outcomes and device effectiveness according to treatment extent in the superficial femoral artery (SFA), popliteal artery (PA), or both. METHODS In this study, we analysed EVT for SFA (2,404 limbs), PA (155 limbs), SFA/PA (383 limbs) using the population in the K-VIS ELLA (Korean Vascular Intervention Society Endovascular Therapy in Lower Limb Artery Diseases) registry. The primary endpoint was target lesion revascularisation (TLR) at 2 years. RESULTS The SFA/PA group exhibited a higher prevalence of anatomical complexity, characterised by long lesions, moderate to severe calcification, and total occlusion. The procedures were successful in 97.2% of SFA, 92.9% of PA, and 95.6% of SFA/PA EVTs. The 2-year TLR rates were 21.1%, 18.6%, and 32.7% in the SFA, PA, and SFA/PA groups, respectively. SFA/PA EVT was associated with a significantly increased risk for TLR compared to the SFA group (adjusted hazard ratio [HR] 1.48 [1.09-2.00]; p=0.008) and a trend towards an increased risk compared to the PA group (adjusted HR 1.80 [1.00-3.27]; p=0.052). After overlap weighting, the use of a drug-coated balloon (DCB) was shown to be beneficial, with the lowest TLR rate after SFA and SFA/PA EVT. CONCLUSIONS In this large real-world registry, SFA/PA EVT was associated with an increased risk for TLR at 2 years compared to the SFA or PA EVT groups, with favourable outcomes when using a DCB or drug-eluting stent in the SFA/PA EVT group.
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Affiliation(s)
- Yong-Hoon Yoon
- Department of Cardiology, Chungnam National University Sejong Hospital, Chungnam National University School of Medicine, Sejong, Republic of Korea
| | - Jae-Hwan Lee
- Department of Cardiology, Chungnam National University Sejong Hospital, Chungnam National University School of Medicine, Sejong, Republic of Korea
| | - Won-Mook Hwang
- Department of Cardiology, Chungnam National University Sejong Hospital, Chungnam National University School of Medicine, Sejong, Republic of Korea
| | - Hyun-Woong Park
- Department of Cardiology, Chungnam National University Sejong Hospital, Chungnam National University School of Medicine, Sejong, Republic of Korea
| | - Jae-Hyung Roh
- Department of Cardiology, Chungnam National University Sejong Hospital, Chungnam National University School of Medicine, Sejong, Republic of Korea
| | - Seung-Jun Lee
- Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea
| | - Young-Guk Ko
- Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea
| | - Chul-Min Ahn
- Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea
| | - Cheol Woong Yu
- Department of Cardiology, Cardiovascular Center, Korea University, Anam Hospital, Korea University College of Medicine, Seoul, Republic of Korea
| | - Seung-Whan Lee
- Department of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea
| | - Young Jin Youn
- Division of Cardiology, Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju, Republic of Korea
| | - Jong Kwan Park
- Division of Cardiology, Department of Internal Medicine, National Health Insurance Service Ilsan Hospital, Goyang, Republic of Korea
| | - Chang-Hwan Yoon
- Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea
- Department of Cardiology, Seoul National University Bundang Hospital, Seongnam, Republic of Korea
| | - Seung-Woon Rha
- Cardiovascular Center, Division of Cardiology, Department of Internal Medicine, Korea University Guro Hospital, Korea University College of Medicine, Seoul, Republic of Korea
| | - Pil-Ki Min
- Division of Cardiology, Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea
| | - Seung-Hyuk Choi
- Division of Cardiology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea
| | - In-Ho Chae
- Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea
- Department of Cardiology, Seoul National University Bundang Hospital, Seongnam, Republic of Korea
| | - Donghoon Choi
- Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea
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17
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Kim YH, Her AY, Ko YG, Ahn CM, Lee SJ, Hong MK, Yu CW, Lee JH, Lee SW, Youn YJ, Yoon CH, Rha SW, Min PK, Choi SH, Chae IH, Choi D. Drug-coated balloon versus drug-eluting stent for femoropopliteal total occlusions: intraluminal versus subintimal approaches. Sci Rep 2024; 14:21173. [PMID: 39256427 PMCID: PMC11387717 DOI: 10.1038/s41598-024-71745-0] [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: 01/18/2024] [Accepted: 08/30/2024] [Indexed: 09/12/2024] Open
Abstract
Because there is a lack of comparative studies assessing drug-coated balloon (DCB) and drug-eluting stent (DES) outcomes with respect to intraluminal (IL) and subintimal (SI) approaches in femoropopliteal (FP) total occlusive lesions, we compared the outcomes between DCB (including bailout stenting) and DES treatments for this lesion. A total of 487 limbs (434 patients) were divided into the IL (n = 344, DCB: n = 268, DES: n = 76) and SI (n = 143, DCB: n = 83, DES: n = 60) approach groups. The primary outcome was a major adverse limb event (MALE), defined as above-ankle amputation or repeat revascularization of the index limb. Secondary outcomes included clinically driven target lesion revascularization (TLR), loss of clinical patency, and all-cause death. After adjustment, in each IL and SI approach, the 2-year rates of MALE (p = 0.180 and p = 0.236, respectively), TLR, loss of clinical patency, and all-cause death were similar between the DCB and DES groups. In the DCB and DES groups, both primary and secondary outcomes were similar between the IL and SI approaches. DCB and DES strategies for patients presenting with FP total occlusive lesions demonstrated similar outcomes regardless of the IL or SI approach.Clinical Trial Registration: NCT02748226.
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Affiliation(s)
- Yong Hoon Kim
- Division of Cardiology, Department of Internal Medicine, Kangwon National University College of Medicine, Kangwon National University School of Medicine, 156 Baengnyeong Road, Chuncheon, Gangwon, 24289, Republic of Korea.
| | - Ae-Young Her
- Division of Cardiology, Department of Internal Medicine, Kangwon National University College of Medicine, Kangwon National University School of Medicine, 156 Baengnyeong Road, Chuncheon, Gangwon, 24289, Republic of Korea
| | - Young-Guk Ko
- Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-Gu, Seoul, 03722, Republic of Korea.
| | - Chul-Min Ahn
- Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-Gu, Seoul, 03722, Republic of Korea
| | - Seung-Jun Lee
- Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-Gu, Seoul, 03722, Republic of Korea
| | - Myeong-Ki Hong
- Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-Gu, Seoul, 03722, Republic of Korea
| | - Cheol Woong Yu
- Division of Cardiology, Korea University Anam Hospital, Seoul, Republic of Korea
| | - Jae-Hwan Lee
- Division of Cardiology, Department of Internal Medicine Chungnam, National University Hospital, Sejong, Republic of Korea
| | - Seung Whan Lee
- Division of Cardiology, Department of Internal Medicine, Asan Medical Center University of Ulsan College of Medicine, Seoul, Republic of Korea
| | - Young Jin Youn
- Division of Cardiology, Department of Internal Medicine, Wonju Severance Christian Hospital, Wonju, Republic of Korea
| | - Chang-Hwan Yoon
- Division of Cardiology, Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea
| | - Seung-Woon Rha
- Cardiovascular Center, Korea University Guro Hospital, Seoul, Republic of Korea
| | - Pil-Ki Min
- Division of Cardiology, Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea
| | - Seung-Hyuk Choi
- Division of Cardiology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea
| | - In-Ho Chae
- Division of Cardiology, Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea
| | - Donghoon Choi
- Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-Gu, Seoul, 03722, Republic of Korea
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18
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Bertagna G, Troisi N, Lepidi S, Patrone L, Yeung KK, Berchiolli R, D'Oria M. International Cross-Sectional S urvey O N T Reatment Of Occluded Femoro-Popliteal Stents (SUNROOF). J Endovasc Ther 2024:15266028241275827. [PMID: 39240031 DOI: 10.1177/15266028241275827] [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: 09/07/2024]
Abstract
PURPOSE The aim of this project is to explore practice patterns of experienced vascular specialists involved in the treatment of patients with arterial femoro-popliteal in-stent occlusion (ISO) and to understand key concepts and shared thoughts, throughout an international cross-sectional survey. MATERIALS AND METHODS The web-based survey was in English and included 31 questions. One-hundred experts were invited by email to fill in the survey anonymously on Google Forms using a dedicated link. Reminders were sent after the first 2 weeks. In addition to reporting of pooled responses, subanalyses of answers were also performed, according to country of origin (European vs non-European), years of experience (≤20 years vs >20 years), and type of institution (Academic/University vs Non-academic/Private). RESULTS A total of 77 physicians from 22 countries completed the survey. Most responders were males (70/77, 91%). Most of the participants were vascular surgeons (58/77, 75%). Endovascular therapy was the preferred option in patients presenting with either acute limb ischemia, disabling intermittent claudication, or chronic limb-threatening ischemia. Atherectomy/thrombectomy+Drug-Coated Balloon (DCB) was the preferred endovascular modality (32/77, 42%). No differences between country of origin, years of experience, and type of institution of the participants were found. CONCLUSIONS The international SUrvey oN TReatment Of Occluded Femoro-Popliteal Stent (SUNROOF) survey has suggested that endovascular therapy is the preferred method for the treatment of femoro-popliteal ISO. This survey could represent a good starting point for future research on comparison between open and endovascular approach and different devices, which currently lacks good-level scientific evidence and appropriate guidelines. CLINICAL IMPACT The international SUNROOF survey included 31 questions. It was performed by 77 vascular physicians from 22 countries. More than a half of respondents considered an endovascular approach as the preferred treatment modality in acute limb ischemia, disabling intermittent claudication, or chronic limb-threatening ischemia. Most responders agreed they would intensify the follow-up protocol and anti-thrombotic medications regimen after a first in-stent occlusion episode. This survey could represent a good starting point for future research on comparison between open and endovascular approach and different devices, which currently lacks of good level scientific evidence and appropriate guidelines.
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Affiliation(s)
- Giulia Bertagna
- Vascular Surgery Unit, Department of Translational Research and of New Surgical and Medical Technologies, University of Pisa, Italy
| | - Nicola Troisi
- Vascular Surgery Unit, Department of Translational Research and of New Surgical and Medical Technologies, University of Pisa, Italy
| | - Sandro Lepidi
- Division of Vascular and Endovascular Surgery, Cardiovascular Department, University Hospital of Trieste, ASUGI, Trieste, Italy
| | - Lorenzo Patrone
- West London Vascular and Interventional Centre, Northwick Park Hospital, Harrow, UK
| | - Kak Khee Yeung
- Vascular Surgery, Department of Surgery, Location VU Medical Center and Academic Medical Center, Amsterdam University Medical Center, Amsterdam, The Netherlands
| | - Raffaella Berchiolli
- Vascular Surgery Unit, Department of Translational Research and of New Surgical and Medical Technologies, University of Pisa, Italy
| | - Mario D'Oria
- Division of Vascular and Endovascular Surgery, Cardiovascular Department, University Hospital of Trieste, ASUGI, Trieste, Italy
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19
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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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20
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Nakama T, Takahara M, Iwata Y, Suzuki K, Tobita K, Hayakawa N, Horie K, Mori S, Obunai K, Ohki T. One-year Outcomes of Drug-Eluting Stent Versus Drug-Coated Balloon for Femoropopliteal Artery Lesions: BEASTARS Study Results. J Endovasc Ther 2024:15266028241271725. [PMID: 39183676 DOI: 10.1177/15266028241271725] [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: 08/27/2024]
Abstract
BACKGROUND Previous reports have shown comparable outcomes between drug-eluting stents (DESs) and drug-coated balloons (DCBs) for treating femoropopliteal artery (FPA) lesions; however, DCB outcomes include approximately 10% to 50% bailout stents. Therefore, comparing DESs and DCBs is not simple. The aim of this study was to compare the clinical outcomes of DESs and DCBs in patients with symptomatic FPA disease. MATERIALS AND METHODS Using the registries of 7 institutions, we retrospectively reviewed the records of 1356 patients who underwent endovascular therapy for FPA with DESs (n=333; Eluvia, 74.0%; Zilver PTX stent, 26.0%) or DCBs without bailout stents (n=1023; IN.PACT, 67.6%; Lutonix, 32.4%). The primary outcome was the 1-year primary patency comparison between DESs and DCBs, using propensity score matching. The severity of the dissection pattern after predilatation (none or grades A-C) was included as an explanatory variable for matching. Patients with grade D dissections were excluded from the main analysis and assessed independently. RESULTS After matching, the 1-year primary patency between DESs and DCBs was similar (88.8% vs 85.2%, p=0.31). By contrast, perioperative complications were frequent with DES, compared with DCB (5.1% vs 2.2%, p=0.005), and the intravascular ultrasound-evaluated minimum luminal area was significantly larger with DES than with DCB (19 mm2 vs 14 mm2, p<0.001). In the supplemental analysis of lesions with grade D dissection, the 1-year primary patency was significantly higher with DES than with DCB (86.1% vs 55.1%, p=0.014). CONCLUSION In FPA lesions without severe dissection (ie, no dissection or grade A-C dissection), DESs and DCBs showed comparable 1-year primary patency in matched populations. However, DCBs did not perform well with severe dissection (ie, grade D or more). CLINICAL IMPACT The results of this study clearly define the appropriate boundaries for the "leaving nothing behind" strategy. Clinicians can now more clearly differentiate between the use of DES and DCB, based on the results of lesion preparation. Further prospective investigations with well-designed trials and larger populations are necessary to confirm these findings.
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Affiliation(s)
- Tatsuya Nakama
- Department of Cardiology, Tokyo Bay Medical Center, Urayasu, Japan
- Division of Vascular Surgery, Department of Surgery, The Jikei University School of Medicine, Tokyo, Japan
| | - Mitsuyoshi Takahara
- Department of Metabolic Medicine, Graduate School of Medicine, Osaka University, Osaka, Japan
| | - Yo Iwata
- Department of Cardiology, Heart and Vascular Institute, Funabashi Municipal Medical Center, Funabashi, Japan
| | - Kenji Suzuki
- Department of Cardiology, Tokyo Saiseikai Central Hospital, Tokyo, Japan
| | - Kazuki Tobita
- Department of Cardiology, Shonan Kamakura General Hospital, Kamakura, Japan
| | - Naoki Hayakawa
- Department of Cardiovascular Medicine, Asahi General Hospital, Asahi, Japan
| | - Kazunori Horie
- Department of Cardiovascular Medicine, Sendai Kousei Hospital, Sendai, Japan
| | - Shinsuke Mori
- Department of Cardiology, Saiseikai Yokohama City Eastern Hospital, Yokohama, Japan
| | - Kotaro Obunai
- Department of Cardiology, Tokyo Bay Medical Center, Urayasu, Japan
| | - Takao Ohki
- Division of Vascular Surgery, Department of Surgery, The Jikei University School of Medicine, Tokyo, Japan
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21
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Zhang F, Song HX, Zheng LH, An YB, Liu P. Long-term clinical efficacy of drug-coated balloon angioplasty for TASCII C/D femoropopliteal lesions in older patients with chronic limb-threatening ischemia: A retrospective study. Medicine (Baltimore) 2024; 103:e39331. [PMID: 39151525 PMCID: PMC11332706 DOI: 10.1097/md.0000000000039331] [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: 12/07/2023] [Revised: 04/10/2024] [Accepted: 07/26/2024] [Indexed: 08/19/2024] Open
Abstract
This study aimed to evaluate the long-term clinical outcomes of drug-coated drug (DCB) angioplasty for long femoropopliteal lesions in older patients with chronic limb-threatening ischemia (CLTI). In this multi-center retrospective study, we enrolled 119 patients with CLTI due to Trans-Atlantic Inter-Society Consensus (TASCII) C/D femoropopliteal lesions who underwent DCB angioplasty. A total of 119 patients with 122 limbs (TASCII C = 67, 54.9%; TASCII D = 55, 45.1%) were enrolled. At 36-month follow-up, primary patency, assisted primary patency, secondary patency, and freedom from target lesion revascularization were 47.3%, 49.8%, 59.5%, and 62.7%, respectively, and there was a significant improvement over baseline in Rutherford class (P < .001) and ankle-brachial index measurements (P < .001). Complex target lesions (P = .017) and 1 stenosis-free outflow vessel (P = .001) were risk predictors of freedom from clinically driven target lesion revascularization. Complex target lesions (P = .044), diabetes (P = .007), and 1 stenosis-free outflow vessel (P = .003) were risk predictors of restenosis. At 2 months, the ulcer healing rate was 96.3% (26/27). At 36 months, the limb salvage and survival rates were 85.8% and 83.3%, respectively. DCB angioplasty were safe and effective for older patients with CLTI attributable to femoropopliteal TASCII C/D lesions.
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Affiliation(s)
- Feng Zhang
- Department of Vascular and Endovascular Surgery, Hebei Key Laboratory of Colorectal Cancer Precision Diagnosis and Treatment, The First Hospital of Hebei Medical University, Shijiazhuang, Hebei, PR China
| | - Hai-Xia Song
- Department of Neurology, Shijiazhuang People’s Hospital, Shijiazhuang, Hebei, PR China
| | - Li-Hua Zheng
- Department of Vascular and Endovascular Surgery, Hebei Key Laboratory of Colorectal Cancer Precision Diagnosis and Treatment, The First Hospital of Hebei Medical University, Shijiazhuang, Hebei, PR China
| | - Yan-Bo An
- Department of Vascular and Endovascular Surgery, Hebei Key Laboratory of Colorectal Cancer Precision Diagnosis and Treatment, The First Hospital of Hebei Medical University, Shijiazhuang, Hebei, PR China
| | - Peng Liu
- Department of Vascular and Endovascular Surgery, Hebei Key Laboratory of Colorectal Cancer Precision Diagnosis and Treatment, The First Hospital of Hebei Medical University, Shijiazhuang, Hebei, PR China
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22
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Soga Y, Takahara M, Iida O, Tomoi Y, Kawasaki D, Fujihara M, Kozuki A, Tanaka A, Yamauchi Y, Tobita K, Yamaoka T, Ichihashi S, Ando K. High-Dose Drug-Coated Balloon Versus Polymer-Based Drug-Eluting Stent for Femoropopliteal Artery Disease Treatment. J Endovasc Ther 2024:15266028241267759. [PMID: 39148336 DOI: 10.1177/15266028241267759] [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: 08/17/2024]
Abstract
PURPOSE Clinical trials have demonstrated that high-dose drug-coated balloon (HD-DCB) and polymer-based drug-eluting stent (PB-DES) treatments for femoropopliteal (FP) artery disease have favorable outcomes. However, which one would be better remained unrevealed. METHODS This study used the databases of 2 large-scale multicenter prospective drug-coated balloon (DCB) and drug-eluting stent (DES) registries. The study included 2470 patients with symptomatic FP lesion treated with IN.PACT Admiral DCB or Eluvia DES at 69 centers. A propensity-score-based paired analysis was conducted. Primary endpoint was 1-year restenosis rate. Secondary endpoints were 1-year reocclusion rate, target lesion revascularization (TLR), acute thrombosis, bypass conversion, major amputation, major adverse limb event (MALE), and all-cause death. RESULTS A total of 1535 patients were treated with HD-DCB, and 935 patients were treated with PB-DES. The propensity-score matching extracted 678 pairs, with no remarkable intergroup difference in baseline characteristics. The 1-year restenosis rate was significantly lower in the PB-DES group than in the HD-DCB group (16.0% vs 22.0%, p=0.016). The other endpoints (reocclusion rate, TLR, acute thrombosis, bypass conversion, major amputation, MALE, and all-cause death) did not differ between the groups. No baseline characteristics had any significant interaction effect on the association of HD-DCB vs PB-DES with restenosis risk (all p>0.05). CONCLUSIONS This study demonstrated that the 1-year TLR, reocclusion rate, and other endpoints did not differ between the PB-DES group and the HD-DCB group despite the lower restenosis in the PB-DES group. CLINICAL IMPACT One-year restenosis rate was significantly lower in the polymer-based DES group than in the high-dose DCB group for foemoropopliteal disease. However, there is no difference in the other endpoints between two groups.
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Affiliation(s)
| | | | | | | | | | | | | | | | | | | | | | | | - Kenji Ando
- Kokura Memorial Hospital, Kitakyushu, Japan
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23
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Seyferth ER, Song H, Vance AZ, Clark TWI. Association between statin intensity and femoropopliteal stent primary patency in peripheral arterial disease. CVIR Endovasc 2024; 7:60. [PMID: 39096322 PMCID: PMC11297851 DOI: 10.1186/s42155-024-00472-4] [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: 06/15/2024] [Accepted: 07/24/2024] [Indexed: 08/05/2024] Open
Abstract
BACKGROUND Statins are widely used in coronary and peripheral arterial disease, but their impact on patency of stents placed for peripheral arterial disease is not well-studied. The purpose of this study was to evaluate femoropopliteal stent primary patency according to statin intensity at the time of stent placement and compare this effect to other covariates that may influence stent patency. MATERIALS AND METHODS A retrospective review identified 278 discrete femoropopliteal stent constructs placed in 216 patients over a 10-year period; Rutherford categories were 2 (3.6%), 3 (12.9%), 4 (21.2%), 5 (49.6%), and 6 (12.6%). Stent locations were common femoral (1.8%), common femoral/superficial femoral (0.7%), superficial femoral (50.7%), superficial femoral/popliteal (32.7%) and popliteal (14.0%) arteries; 63.3% of stents were paclitaxel-eluting. Primary patency of each stent construct was determined with duplex ultrasound, angiography, or computed tomographic angiography. Greater than 50% restenosis or stent occlusion was considered loss of patency. Cox proportional hazard and Kaplan-Meier modeling were used to assess the effect of statin use and additional covariates on stent patency. RESULTS Patients on any statin at the time of stent placement were half as likely to undergo loss of primary unassisted patency as patients on no statin therapy (hazard ratio, 0.53; 95% confidence interval, 0.19-0.87; P = .004). Moderate/high intensity statin therapy conferred 17 additional months of median stent patency compared to the no statin group. Antiplatelet therapy, anticoagulant therapy, drug-eluting stents (versus bare metal or covered stents), and Rutherford class were not predictive of stent patency (P = 0.52, 0.85, 0.58, and 0.82, respectively). CONCLUSION Use of statin therapy at the time of femoropopliteal stent placement was the most predictive examined variable influencing primary unassisted patency.
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Affiliation(s)
- Elisabeth R Seyferth
- Section of Interventional Radiology, Department of Radiology, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA
| | - Helen Song
- Section of Interventional Radiology, Department of Radiology, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA
| | - Ansar Z Vance
- Section of Interventional Radiology, Department of Radiology, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA
| | - Timothy W I Clark
- Section of Interventional Radiology, Department of Radiology, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.
- University of Pennsylvania Perelman School of Medicine, Penn Presbyterian Medical Center, Philadelphia, PA, 19104, USA.
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24
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Zhou Y, Wang T, He H, Li Q, Wan Z, Lu P, Shu C. Comparative effectiveness of endovascular treatment modalities for de novo femoropopliteal lesions at long-term follow-up: A network meta-analysis of randomized controlled trials. Int J Cardiol 2024; 404:131977. [PMID: 38508322 DOI: 10.1016/j.ijcard.2024.131977] [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: 10/06/2023] [Revised: 03/08/2024] [Accepted: 03/15/2024] [Indexed: 03/22/2024]
Abstract
PURPOSE To evaluate the best endovascular treatment for de novo femoropopliteal lesions at long-term follow-up through network meta-analysis of randomized controlled trials. METHODS Medical databases were searched on September 17, 2023. 17 trials and 7 treatments were selected. Outcomes were primary patency, target lesion revascularization (TLR), major amputation and all-cause mortality at 3 and/or 5 years. RESULTS Regarding 3-year primary patency, drug-eluting stents (DES) was the best and better than balloon angioplasty (BA; odds ratio [OR], 4.96; 95% confidence interval [CI], 2.68-9.18), bare metal stents (BMS; OR, 2.81; 95% CI, 1.45-5.46), cryoplasty (OR, 6.75; 95% CI, 2.76-16.50), covered stents (CS; OR, 3.25; 95% CI, 1.19-8.87) and drug-coated balloons (DCB; OR, 2.04; 95% CI, 1.14-3.63). Regarding 5-year primary patency, DES was the best and better than BMS (OR, 2.34; 95% CI, 1.10-4.99). Regarding 3-year TLR, DES was the best and better than BA (OR, 0.24; 95% CI, 0.13-0.44). Regarding 5-year TLR, DES was the best and better than BA (OR, 0.20; 95% CI, 0.09-0.42) and balloon angioplasty with brachytherapy (OR, 0.21; 95% CI, 0.06-0.74). Regarding 3- and 5-year major amputation, DCB was the best. Regarding 3-year mortality, DES was the best and better than CS (OR, 0.09; 95% CI, 0.01-0.67). CONCLUSIONS DES was the best treatment regarding 3-year primary patency, TLR and mortality, and DCB was the best regarding major amputation. DES was the best treatment regarding 5-year TLR, and DCB was the best regarding primary patency and major amputation. DES and DCB should be given priority in treating femoropopliteal lesions.
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Affiliation(s)
- Yang Zhou
- Department of Vascular Surgery, The Second Xiangya Hospital of Central South University, Changsha, Hunan, China; Vascular Disease Institute of Central South University, Changsha, Hunan, China
| | - Tun Wang
- Department of Vascular Surgery, The Second Xiangya Hospital of Central South University, Changsha, Hunan, China; Vascular Disease Institute of Central South University, Changsha, Hunan, China
| | - Hao He
- Department of Vascular Surgery, The Second Xiangya Hospital of Central South University, Changsha, Hunan, China; Vascular Disease Institute of Central South University, Changsha, Hunan, China
| | - Quanming Li
- Department of Vascular Surgery, The Second Xiangya Hospital of Central South University, Changsha, Hunan, China; Vascular Disease Institute of Central South University, Changsha, Hunan, China
| | - Zicheng Wan
- Department of Vascular Surgery, The Second Xiangya Hospital of Central South University, Changsha, Hunan, China; Vascular Disease Institute of Central South University, Changsha, Hunan, China
| | - Peng Lu
- Department of Vascular Surgery, The Second Xiangya Hospital of Central South University, Changsha, Hunan, China; Vascular Disease Institute of Central South University, Changsha, Hunan, China
| | - Chang Shu
- Department of Vascular Surgery, The Second Xiangya Hospital of Central South University, Changsha, Hunan, China; Vascular Disease Institute of Central South University, Changsha, Hunan, China; Department of Vascular Surgery, Fuwai Hospital, Chinese Academy of Medical Science and Peking Union Medical College, Beijing, China.
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25
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Shimizu H, Kobayashi T, Okazaki T, Mochizuki S, Maeda K, Sato T, Emura S, Arai Y, Kato Y, Takahashi S. Clinical impact of fluoropolymer-based drug-eluting stent thrombosis in femoropopliteal artery occlusive lesions. Vascular 2024:17085381241258553. [PMID: 38811860 DOI: 10.1177/17085381241258553] [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: 05/31/2024]
Abstract
BACKGROUND Endovascular treatment (EVT) is recommended for superficial femoral artery (SFA) lesions, and good results have been reported after implantation of drug-eluting stents (DES) for SFA. However, the major concern after implantation is acute thrombosis during the follow-up period, resulting in major amputation and major adverse limb events. In this study, we examined the incidence and outcome of acute thrombosis after DES implantation in the SFA. OBJECTIVES AND METHODS DES implantation for a femoropopliteal lesion was performed in 288 patients at multiple centers in Japan from 2019 to 2021. A total of 25 patients (8.6%) with DES acute occlusion were analyzed retrospectively. The primary endpoint was amputation-free survival (AFS) after acute occlusion. RESULTS The median patient age was 77 years, with 48% having diabetes, 40% undergoing maintenance dialysis, and 66% having chronic limb-threatening ischemia (CLTI). The mean time from initial DES implantation to acute occlusion was 153.5 ± 177.6 days, with a median of 104 days. EVT was performed in 18 patients (72%), surgical revascularization in 3 (12%), and conservative treatment in 4 (16%). Two deaths within 30 days were both due to sepsis. No major amputation or major adverse cardiovascular events occurred within 30 days. The 1-year rates of patency and freedom from target lesion revascularization after DES thrombosis were 22.9% and 48.8%, respectively. AFS at 1 year was 55.1%. CONCLUSION Acute DES occlusion is relatively frequent, and the outcome is poor. Therefore, the indication of DES implantation for a complex SFA lesion may require careful consideration. Further investigation may be needed in DES implantation for a complex SFA lesion.
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Affiliation(s)
- Haruna Shimizu
- Department of Cardiovascular Surgery, Hiroshima University Hospital, Hiroshima, Japan
| | - Taira Kobayashi
- Department of Cardiovascular Surgery, JA Hiroshima General Hospital, Hatsukaichi-shi, Japan
| | - Takanobu Okazaki
- Department of Cardiovascular Surgery, JA Hiroshima General Hospital, Hatsukaichi-shi, Japan
| | - Shingo Mochizuki
- Department of Cardiovascular Surgery, Akane-Foundation Tsuchiya General Hospital, Hiroshima, Japan
| | - Kazuki Maeda
- Department of Cardiovascular Surgery, Akane-Foundation Tsuchiya General Hospital, Hiroshima, Japan
| | - Tomoyasu Sato
- Department of Radiology, Akane-Foundation Tsuchiya General Hospital, Hiroshima, Japan
| | - Shogo Emura
- Department of Cardiovascular Surgery, National Hospital Organization Higashihiroshima Medical Center, Higashihiroshima-shi, Japan
| | - Yasunori Arai
- Department of Cardiology, Fukuyama City Hospital, Fukuyama-shi, Japan
| | - Yuichi Kato
- Department of Cardiology, Fukuyama City Hospital, Fukuyama-shi, Japan
| | - Shinya Takahashi
- Department of Cardiovascular Surgery, Hiroshima University Hospital, Hiroshima, Japan
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26
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Wittig T, Schmidt A, Fuß T, Thieme M, Maiwald L, Düsing S, Konert M, Fischer A, Scheinert D, Steiner S. Randomized Trial Comparing a Stent-Avoiding With a Stent-Preferred Strategy in Complex Femoropopliteal Lesions. JACC Cardiovasc Interv 2024; 17:1134-1144. [PMID: 38749594 DOI: 10.1016/j.jcin.2024.03.015] [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: 12/29/2023] [Revised: 03/05/2024] [Accepted: 03/12/2024] [Indexed: 06/15/2024]
Abstract
BACKGROUND Limited comparative data exist on different interventional strategies for endovascular revascularization of complex femoropopliteal interventions. OBJECTIVES In this study, the authors aimed to compare a stent-avoiding (SA) vs a stent-preferred (SP) strategy, promoting optimal lesion preparation and the use of drug-eluting technologies in both arms. METHODS Within a prospective, multicenter, pilot study, 120 patients with symptomatic complex femoropopliteal lesions (Rutherford classification 2-4, mean lesion length 187.7 ± 78.3 mm, 79.2% total occlusions) were randomly assigned in a 1:1 fashion to endovascular treatment with either paclitaxel-coated balloons or polymer-coated, paclitaxel-eluting stents. Lesion preparation including the use of devices for plaque modification and/or removal was at the operators' discretion in both treatment arms. RESULTS In the SA group, lesion preparation was more frequently performed (71.7% SA [43/60] vs 51.7% [31/60] SP; P = 0.038) with a high provisional stenting rate (48.3% [29/60]). At the 12-month follow-up, primary patency was 78.2% (43/55) in the SA group and 78.6% (44/56) in the SP group (P = 1.0; relative risk: 0.995; 95% CI: 0.818-1.210). Freedom from major adverse events was determined in 93.1% (54/58) in the SA group and in 94.9% (56/59) in the SP group (P = 0.717; relative risk: 0.981; 95% CI: 0.895-1.075), with all adverse events attributable to clinically driven target lesion revascularization. CONCLUSIONS Both endovascular strategies promoting lesion preparation before the use of drug-eluting devices suggest promising efficacy and safety results in complex femoropopliteal procedures with a high proportion of total occlusions through 12 months. Ongoing follow-up will show whether different results emerge over time. (Best Endovascular Strategy for Complex Lesions of the Superficial Femoral Artery [BEST-SFA]; NCT03776799).
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Affiliation(s)
- Tim Wittig
- Division of Angiology, Department of Internal Medicine, Neurology and Dermatology, University Hospital Leipzig, Leipzig, Germany; Helmholtz Institute for Metabolic, Obesity and Vascular Research of the Helmholtz Center Munich at the University of Leipzig and University Hospital Leipzig, Leipzig, Germany
| | - Andrej Schmidt
- Division of Angiology, Department of Internal Medicine, Neurology and Dermatology, University Hospital Leipzig, Leipzig, Germany
| | - Torsten Fuß
- Department of Internal Medicine, Elblandklinikum Radebeul, Radebeul, Germany
| | - Marcus Thieme
- Department of Angiology, Regiomed Gefäßzentrum Sonneberg, Sonneberg, Germany
| | - Lars Maiwald
- Department of Angiology, Kreiskrankenhaus Torgau, Torgau, Germany
| | - Sandra Düsing
- Division of Angiology, Department of Internal Medicine, Neurology and Dermatology, University Hospital Leipzig, Leipzig, Germany
| | - Manuela Konert
- Division of Angiology, Department of Internal Medicine, Neurology and Dermatology, University Hospital Leipzig, Leipzig, Germany
| | - Axel Fischer
- Division of Angiology, Department of Internal Medicine, Neurology and Dermatology, University Hospital Leipzig, Leipzig, Germany
| | - Dierk Scheinert
- Division of Angiology, Department of Internal Medicine, Neurology and Dermatology, University Hospital Leipzig, Leipzig, Germany
| | - Sabine Steiner
- Division of Angiology, Department of Internal Medicine, Neurology and Dermatology, University Hospital Leipzig, Leipzig, Germany; Helmholtz Institute for Metabolic, Obesity and Vascular Research of the Helmholtz Center Munich at the University of Leipzig and University Hospital Leipzig, Leipzig, Germany.
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Jinnouchi H, Sakakura K, Yamamoto K, Taniguchi Y, Fujita H. A unique mechanism of restenosis after drug-coated balloon in peripheral artery: Insight from optical frequency domain imaging. CARDIOVASCULAR REVASCULARIZATION MEDICINE 2024; 62:119-122. [PMID: 38114363 DOI: 10.1016/j.carrev.2023.12.004] [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: 12/05/2023] [Accepted: 12/05/2023] [Indexed: 12/21/2023]
Abstract
Drug-coated balloons (DCBs) have been widely used in endovascular therapy for femoropopliteal arteries with atherosclerotic lesions. Vascular response after DCBs remains unclear. This mini-review proposes a possible mechanism of restenosis after the DCB strategy. Balloon dilatation including DCBs expands the vascular lumen by producing dissections, which is composed of the original vascular lumen and the cavity surrounded by dissected flaps. The cavity surrounded by dissected flaps is eventually replaced with the thrombus in the healing process after balloon dilatation. However, the thrombus may propagate to the expanded vascular lumen through the entry point of the dissection. Subsequently, the thrombus both in the cavity and the expanded lumen would be organized over time. The vascular lumen in the chronic-phase after DCBs may be influenced by the propagated thrombus from the cavity surrounded by dissected flaps.
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Affiliation(s)
- Hiroyuki Jinnouchi
- Division of Cardiovascular Medicine, Saitama Medical Center, Jichi Medical University, Japan.
| | - Kenichi Sakakura
- Division of Cardiovascular Medicine, Saitama Medical Center, Jichi Medical University, Japan
| | - Kei Yamamoto
- Division of Cardiovascular Medicine, Saitama Medical Center, Jichi Medical University, Japan
| | - Yousuke Taniguchi
- Division of Cardiovascular Medicine, Saitama Medical Center, Jichi Medical University, Japan
| | - Hideo Fujita
- Division of Cardiovascular Medicine, Saitama Medical Center, Jichi Medical University, Japan
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Lu K, Ye X, Chen Y, Wang P, Gong M, Xuan B, Tang Z, Li M, Hou J, Peng K, Pei H. Research progress of drug eluting balloon in arterial circulatory system. Front Cardiovasc Med 2024; 11:1287852. [PMID: 38601040 PMCID: PMC11005962 DOI: 10.3389/fcvm.2024.1287852] [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: 09/02/2023] [Accepted: 03/04/2024] [Indexed: 04/12/2024] Open
Abstract
The arterial circulatory system diseases are common in clinical practice, and their treatment options have been of great interest due to their high morbidity and mortality. Drug-eluting balloons, as a new type of endovascular interventional treatment option, can avoid the long-term implantation of metal stents and is a new type of angioplasty without stents, so drug-eluting balloons have better therapeutic effects in some arterial circulatory diseases and have been initially used in clinical practice. In this review, we first describe the development, process, and mechanism of drug-eluting balloons. Then we summarize the current studies on the application of drug-eluting balloons in coronary artery lesions, in-stent restenosis, and peripheral vascular disease. As well as the technical difficulties and complications in the application of drug-eluting balloons and possible management options, in order to provide ideas and help for future in-depth studies and provide new strategies for the treatment of more arterial system diseases.
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Affiliation(s)
- Keji Lu
- Department of Cardiology, The Affiliated Hospital, Southwest Medical University, Luzhou, China
- School of Medical and Life Sciences, Chengdu University of TCM, Chengdu, China
| | - Xianglin Ye
- Department of Cardiology, The Affiliated Hospital, Southwest Medical University, Luzhou, China
- Department of Cardiology, The General Hospital of Western Theater Command, Chengdu, China
| | - Yaoxuan Chen
- School of Medical and Life Sciences, Chengdu University of TCM, Chengdu, China
| | - Peng Wang
- Department of Cardiology, The General Hospital of Western Theater Command, Chengdu, China
| | - Meiting Gong
- Department of Cardiology, The General Hospital of Western Theater Command, Chengdu, China
| | - Bing Xuan
- Department of Cardiology, The General Hospital of Western Theater Command, Chengdu, China
| | - Zhaobing Tang
- Department of Rehabilitation, The General Hospital of Western Theater Command, Chengdu, China
| | - Meiling Li
- Department of Cardiology, The General Hospital of Western Theater Command, Chengdu, China
| | - Jun Hou
- Department of Cardiology, Chengdu Third People's Hospital, Chengdu, China
| | - Ke Peng
- Department of Cardiology, The General Hospital of Western Theater Command, Chengdu, China
| | - Haifeng Pei
- Department of Cardiology, The Affiliated Hospital, Southwest Medical University, Luzhou, China
- Department of Cardiology, The General Hospital of Western Theater Command, Chengdu, China
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Long C, Williams AO, McGovern AM, Jacobsen CM, Hargens LM, Duval S, Jaff MR. Diversity in randomized clinical trials for peripheral artery disease: a systematic review. Int J Equity Health 2024; 23:29. [PMID: 38350973 PMCID: PMC10865563 DOI: 10.1186/s12939-024-02104-8] [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: 11/07/2023] [Accepted: 01/13/2024] [Indexed: 02/15/2024] Open
Abstract
BACKGROUND Significant race and sex disparities exist in the prevalence, diagnosis, and outcomes of peripheral artery disease (PAD). However, clinical trials evaluating treatments for PAD often lack representative patient populations. This systematic review aims to summarize the demographic representation and enrollment strategies in clinical trials of lower-extremity endovascular interventions for PAD. METHODS Following the 2020 Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, we searched multiple sources (Medline, EMBASE, Cochrane, Clinicaltrials.gov, WHO clinical trial registry) for randomized controlled trials (RCTs), RCT protocols, and peer-reviewed journal publications of RCTs conducted between January 2012 and December 2022. Descriptive analysis was used to summarize trial characteristics, publication or study protocol characteristics, and the reporting of demographic characteristics. Meta-regression was used to explore associations between demographic characteristics and certain trial characteristics. RESULTS A total of 2,374 records were identified. Of these, 59 met the inclusion criteria, consisting of 35 trials, 14 publications, and 10 protocols. Information regarding demographic representation was frequently missing. While all 14 trial publications reported age and sex, only 4 reported race/ethnicity, and none reported socioeconomic or marital status. Additionally, only 4 publications reported clinical outcomes by demographic characteristics. Meta-regression analysis revealed that 6% more women were enrolled in non-European trials (36%) than in European trials (30%). CONCLUSIONS The findings of this review highlight potential issues that may compromise the reliability and external validity of study findings in lower-extremity PAD RCTs when applied to the real-world population. Addressing these issues is crucial to enhance the generalizability and impact of clinical trial results in the field of PAD, ultimately leading to improved clinical outcomes for patients in underrepresented populations. REGISTRATION The systematic review methodology was published in the International Prospective Register of Systematic Reviews (PROSPERO: CRD42022378304).
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Affiliation(s)
- Chandler Long
- Duke Vascular and Endovascular Surgery, Duke University Medical Center, Duke University, Durham, NC, 27707, USA
| | - Abimbola O Williams
- Health Economics & Market Access, Boston Scientific, Marlborough, MA, 01752, USA.
| | - Alysha M McGovern
- Health Economics & Market Access, Boston Scientific, Marlborough, MA, 01752, USA
| | - Caroline M Jacobsen
- Health Economics & Market Access, Boston Scientific, Marlborough, MA, 01752, USA
| | - Liesl M Hargens
- Health Economics & Market Access, Boston Scientific, Marlborough, MA, 01752, USA
| | - Sue Duval
- Health Economics & Market Access, Boston Scientific, Marlborough, MA, 01752, USA
- Division of Cardiology, Department of Medicine, University of Minnesota, Minneapolis, MN, 55455, USA
| | - Michael R Jaff
- Health Economics & Market Access, Boston Scientific, Marlborough, MA, 01752, USA
- Peripheral Interventions, Boston Scientific, Maple Grove, MN, 55133, USA
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30
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Nordanstig J, Behrendt CA, Baumgartner I, Belch J, Bäck M, Fitridge R, Hinchliffe R, Lejay A, Mills JL, Rother U, Sigvant B, Spanos K, Szeberin Z, van de Water W, Antoniou GA, Björck M, Gonçalves FB, Coscas R, Dias NV, Van Herzeele I, Lepidi S, Mees BME, Resch TA, Ricco JB, Trimarchi S, Twine CP, Tulamo R, Wanhainen A, Boyle JR, Brodmann M, Dardik A, Dick F, Goëffic Y, Holden A, Kakkos SK, Kolh P, McDermott MM. Editor's Choice -- European Society for Vascular Surgery (ESVS) 2024 Clinical Practice Guidelines on the Management of Asymptomatic Lower Limb Peripheral Arterial Disease and Intermittent Claudication. Eur J Vasc Endovasc Surg 2024; 67:9-96. [PMID: 37949800 DOI: 10.1016/j.ejvs.2023.08.067] [Citation(s) in RCA: 122] [Impact Index Per Article: 122.0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/12/2023] [Accepted: 08/14/2023] [Indexed: 11/12/2023]
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31
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Zywicka EM, McNally E, Elliott L, Twine CP, Mouton R, Hinchliffe RJ. Exploring the Reporting Standards of Randomised Controlled Trials Involving Endovascular Interventions for Peripheral Arterial Disease: A Systematic Review. Eur J Vasc Endovasc Surg 2024; 67:155-164. [PMID: 37678660 DOI: 10.1016/j.ejvs.2023.08.066] [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: 02/07/2023] [Revised: 08/04/2023] [Accepted: 08/31/2023] [Indexed: 09/09/2023]
Abstract
OBJECTIVE Endovascular technology innovation requires rigorous evaluation in high quality randomised controlled trials (RCTs). However, due to numerous methodological challenges, RCTs evaluating endovascular interventions are complex and potentially difficult to design, conduct, and report. This systematic review aimed to assess the quality of reporting of RCTs for endovascular interventions for lower limb peripheral arterial disease (PAD). DATA SOURCES AND REVIEW METHODS A systematic review of Medline, Embase, and the Cochrane Library databases from inception to December 2021 was performed to identify RCTs including participants with PAD undergoing any infrainguinal lower limb endovascular intervention. Study data were extracted and assessed against the Consolidating Standards of Reporting Trials extension for Non-Pharmacological Treatments (CONSORT-NPT) and the Template for Intervention Description and Replication (TIDieR) checklists. Descriptive statistics were used to summarise general study details and reporting standards of the trials. RESULTS After screening 6 567 abstracts and 526 full text articles, 112 eligible studies were identified, reporting on 228 different endovascular devices and techniques. Details judged sufficient to replicate the investigated intervention were provided for 47 (21%) interventions. It was unclear whether the description was reported with sufficient details in a further 56 (24%), and the description was judged inadequate in 125 (55%). Any intervention descriptions were provided for 184 (81%), with variable levels of detail (some in 134 [59%] and precise in 50 [22%]). Standardisation of intervention or some aspect of this was reported in 25 (22%) trials, but only one specified that adherence to the study protocol would be monitored. CONCLUSION The quality of the reporting standards of RCTs investigating lower limb endovascular treatments is severely limited because the interventions are poorly described, standardised, and reported. PROSPERO registration number: CRD42022288214.
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Affiliation(s)
- Ewa M Zywicka
- Translational Health Sciences, University of Bristol Medical School, Bristol, UK; Southmead Hospital, North Bristol NHS Trust, Bristol, UK.
| | | | - Lucy Elliott
- Translational Health Sciences, University of Bristol Medical School, Bristol, UK; Southmead Hospital, North Bristol NHS Trust, Bristol, UK
| | - Christopher P Twine
- Translational Health Sciences, University of Bristol Medical School, Bristol, UK; Southmead Hospital, North Bristol NHS Trust, Bristol, UK. http://www.twitter.com/TwineVasc
| | - Ronelle Mouton
- Translational Health Sciences, University of Bristol Medical School, Bristol, UK; Southmead Hospital, North Bristol NHS Trust, Bristol, UK. http://www.twitter.com/RonelleMouton
| | - Robert J Hinchliffe
- Translational Health Sciences, University of Bristol Medical School, Bristol, UK; Southmead Hospital, North Bristol NHS Trust, Bristol, UK. http://www.twitter.com/robhinchliffe1
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32
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Ansel GM. Interventional treatment of PAD: Drug-coated balloons and stents. PATHOPHYSIOLOGY AND TREATMENT OF ATHEROSCLEROTIC DISEASE IN PERIPHERAL ARTERIES 2024:197-212. [DOI: 10.1016/b978-0-443-13593-4.00011-1] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 01/07/2025]
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Ma HK, Wang YM, Guo MP, Li CF, Li R, Gao R. Effectiveness of Acupoint Application in Patients with Pharyngeal Pain: Evidence from CHUNBO, A Prospective Real-World Study. Chin J Integr Med 2024; 30:18-24. [PMID: 37340204 DOI: 10.1007/s11655-023-3699-8] [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] [Accepted: 03/01/2023] [Indexed: 06/22/2023]
Abstract
OBJECTIVE To assess the outcomes after acupoint application in patients with pharyngeal pain in a real-world settings, and analyze the characteristics of effective population and prescription characteristics of acupoint application. METHODS Based on CHUNBO platform, patients with pharyngeal pain who were candidates for acupoint application on the basis of physician-evaluation, were enrolled in a nationwide, prospective, 69-week multicenter observational study from August 2020 to February 2022. Propensity score matching (PSM) was used to match the confounding factors and the association rules were used to analyze the characteristics of effective population and prescription characteristics of acupoint application. Outcome assessments included the disappearance rate of pharyngeal pain (within 3, 7, and 14 days), disappearance time of pharyngeal pain, as well as adverse events. RESULTS Of 7,699 enrolled participants, 6,693 (86.9%) received acupoint application and 1,450 (21.7%) with non-acupoint application. After PSM, there were 1,004 patients each in the application group (AG) and non-application group (NAG). The disappearance rate of pharyngeal pain in the AG at 3, 7, and 14 days were all higher than those in the NAG (P<0.05). The disappearance time of pharyngeal pain in the AG were shorter than that in the NAG (logrank P<0.001, hazard ratio=1.51, 95% confidence interval: 1.41-1.63). The median age of effective cases was 4 years, mainly 3-6 years old (40.21%). The disappearance rate of pharyngeal pain in the application group with tonsil diseases was 2.19 times higher than that in the NAG (P<0.05). The commonly used acupoints for the effective cases were Tiantu (RN 22), Shenque (RN 8) and Dazhui (DU 14). The commonly used herbs for the effective cases were Natrii sulfas, Radix et Rhizoma Rhei, and Herba Ephedrae. Among them, Natrii sulfas was applied to RN 8 most frequently (support 84.39%). A total of 1,324 (17.2%) patients experienced AEs, and mainly occurred in the AG, with significant difference in the incidence of AEs between goups (P<0.05). All AEs reported were the first grade, and the average regression days of AEs was 2.8 days. CONCLUSIONS Acupoint application in patients with pharyngeal pain resulted in improved effective rate and shortened duration, especially children aged 3-6 years old, and those with tonsil diseases. Acupoint of RN 22, RN 8 and DU 14, Natrii sulfas, Radix et Rhizoma Rhei, and Herba Ephedrae were the most commonly used herbs in the treatment of pharyngeal pain.
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Affiliation(s)
- Hang-Kun Ma
- Emergency Department, Xiyuan Hospital Affiliated to China Academy of Chinese Medical Sciences, Beijing, 100091, China
| | - Yi-Ming Wang
- National Medical Products Administration for Laboratory of Clinical Research and Evaluation of Traditional Chinese Medicine, Beijing, 100091, China
- National Clinical Research Center for Chinese Medicine Cardiology, Beijing, 100091, China
| | - Man-Ping Guo
- National Medical Products Administration for Laboratory of Clinical Research and Evaluation of Traditional Chinese Medicine, Beijing, 100091, China
- National Clinical Research Center for Chinese Medicine Cardiology, Beijing, 100091, China
- Postdoctoral Workstation of Yabao Pharmaceutical Group Co., Ltd., Yuncheng, Shanxi Province, 044602, China
| | - Chen-Fei Li
- National Medical Products Administration for Laboratory of Clinical Research and Evaluation of Traditional Chinese Medicine, Beijing, 100091, China
- National Clinical Research Center for Chinese Medicine Cardiology, Beijing, 100091, China
| | - Rui Li
- National Medical Products Administration for Laboratory of Clinical Research and Evaluation of Traditional Chinese Medicine, Beijing, 100091, China
- Postdoctoral Workstation of Yabao Pharmaceutical Group Co., Ltd., Yuncheng, Shanxi Province, 044602, China
| | - Rui Gao
- National Medical Products Administration for Laboratory of Clinical Research and Evaluation of Traditional Chinese Medicine, Beijing, 100091, China.
- National Clinical Research Center for Chinese Medicine Cardiology, Beijing, 100091, China.
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Kurata N, Iida O, Takahara M, Asai M, Okamoto S, Ishihara T, Nanto K, Tsujimura T, Hata Y, Toyoshima T, Higashino N, Nakao S, Mano T. Comparing Predictors Influencing Restenosis Following High-Dose Drug-Coated Balloon Angioplasty and Fluoropolymer-Based Drug-Eluting Stenting in Femoropopliteal Artery Lesions. J Endovasc Ther 2023:15266028231209234. [PMID: 37933462 DOI: 10.1177/15266028231209234] [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: 11/08/2023]
Abstract
PURPOSE Despite widespread use of anti-restenosis devices, drug-coated balloons (DCBs) and drug-eluting stents (DESs), their appropriate use for femoropopliteal (FP) lesions has not been well investigated and the risk factors for restenosis have not been compared. To investigate risk factors associated with restenosis after endovascular therapy using DCB and DES for contemporary FP lesions. MATERIALS AND METHODS This single-center, retrospective, observational study evaluated 378 FP lesions in 273 patients treated with DCB (278 lesions in 193 patients) or DES (120 lesions in 106 patients). The DCB used was high-dose DCB (IN.PACT, Admiral. Medtronic, Inc.) and DES was fluoropolymer-based DES (ELUVIA, Boston Scientific). Vessel preparation failure was defined as a residual stenosis of ≥50% and a dissection grade of D or greater on pre-dilatation angiography. The outcome measure was restenosis, and factors associated with restenosis in the DCB and DES groups were assessed using a Cox proportional hazards model. RESULTS The 2-year restenosis rate was not significantly different between the DCB and DES groups (29%±4% vs. 24%±5%, p=0.42). Interaction analysis demonstrated that popliteal lesions and plaque burden of ≥50% were restenosis-related factors for DES but not for DCB, whereas vessel preparation failure was a factor for DCB but not for DES (p<0.05). Vessel diameter of <6 mm and nodular calcification were risk factors in both groups (p<0.05). CONCLUSION In contemporary FP lesions, smaller vessels and nodular calcification were shared restenosis-related factors for high-dose DCB and fluoropolymer-based DES. Popliteal lesions and plaque burden of ≥50% were restenosis-related factors for fluoropolymer-based DES and vessel preparation failure for high-dose DCB. CLINICAL IMPACT Shared and differential restenosis-related factors after endovascular therapy using high-dose drug-coated balloons (DCBs) and fluoropolymer-based drug-eluting stents (DESs) in contemporary femoropopliteal (FP) lesions are unclear. This single-center retrospective study included 378 FP lesions in 273 patients with lower-extremity arterial disease (high-dose DCB, 278 lesions in 193 patients; fluoropolymer-based DES, 120 lesions in 106 patients). Smaller vessels and calcified nodules were shared restenosis-related factors for both high-dose DCB and fluoropolymer-based DES, whereas popliteal lesions and plaque burden of ≥50% were restenosis-related factors for fluoropolymer-based DES and vessel preparation failure for high-dose DCB.
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Affiliation(s)
- Naoya Kurata
- Department of Clinical Engineering, Kansai Rosai Hospital, Amagasaki, Japan
- Cardiovascular Center, Kansai Rosai Hospital, Amagasaki, Japan
| | - Osamu Iida
- Cardiovascular Center, Kansai Rosai Hospital, Amagasaki, Japan
| | - Mitusyoshi Takahara
- Department of Diabetes Care Medicine, Graduate School of Medicine, Osaka University, Osaka, Japan
| | - Mitsutoshi Asai
- Cardiovascular Center, Kansai Rosai Hospital, Amagasaki, Japan
| | - Shin Okamoto
- Cardiovascular Center, Kansai Rosai Hospital, Amagasaki, Japan
| | | | - Kiyonori Nanto
- Cardiovascular Center, Kansai Rosai Hospital, Amagasaki, Japan
| | | | - Yousuke Hata
- Cardiovascular Center, Kansai Rosai Hospital, Amagasaki, Japan
| | - Taku Toyoshima
- Cardiovascular Center, Kansai Rosai Hospital, Amagasaki, Japan
| | - Naoko Higashino
- Cardiovascular Center, Kansai Rosai Hospital, Amagasaki, Japan
| | - Sho Nakao
- Cardiovascular Center, Kansai Rosai Hospital, Amagasaki, Japan
| | - Toshiaki Mano
- Cardiovascular Center, Kansai Rosai Hospital, Amagasaki, Japan
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Fransson T, Gottsäter A, Abdulrasak M, Malina M, Resch T. Randomized clinical Trial Comparing drug Eluting Stent Zilver PTX® Versus Bare Metal Stent Zilver Flex® for Treatment of Lesions in Femoral and Popliteal Arteries in Chronic Limb Threatening Ischemia. Vasc Endovascular Surg 2023; 57:706-716. [PMID: 37085152 DOI: 10.1177/15385744231171746] [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: 04/23/2023]
Abstract
OBJECTIVE Drug eluting stents (DES) might improve the results of stenting in the femoropopliteal (FP) segment, but randomized data between DES and BMS in the treatment of patients with chronic limb threatening ischemia (CLTI) is lacking. The aim of this study was to perform a randomized comparison, between DES and bare metal stent (BMS) implantation in a subgroup of CLTI patients with lesions in the superficial femoral artery (SFA) and the P1-P2 portion of the popliteal artery. METHODS Patients presenting with CLTI scheduled for endovascular treatment of FP lesions were randomly assigned by blinded envelopes 1:1 in a single blinded, parallel group design to DES or BMS after lesion crossing. Primary endpoints were target lesion revascularization (TLR) at 12 and 24 months and primary patency at 12 and 24 months. Secondary endpoints were technical success (TS), clinical success, secondary patency at 12 and 24 months, limb salvage, serious adverse events (SAE) at 24 month and survival at five years. RESULTS A total of 48 CLTI patients and 49 limbs, were enrolled, 22 in the BMS group and 27 in the DES group. Demographics, comorbidities, and Rutherford class were similar in both treatment arms. The overall rate of total occlusions was 96% and the corresponding overall median lesion length was 240 mm. No patients were lost to follow up. No significant differences were detected between groups regarding TLR and primary patency. The overall primary patency at 12 and 24 months was 42.9% and 36.7% respectively and the overall freedom from TLR was 67.3% and 61.2% respectively. The results in the two groups were also similar regarding secondary outcomes. CONCLUSIONS This single centre, randomized study could not demonstrate superiority of DES compared to BMS when treating long FP lesions in patients with CLTI but was limited by insufficient patient inclusion.
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Affiliation(s)
- Torbjörn Fransson
- Department of Thoracic and Vascular Surgery, Skåne University Hospital, Malmö, Sweden
- Department of Clinical Sciences, Faculty of Medicine, Lund University, Malmö, Sweden
| | - Anders Gottsäter
- Department of Clinical Sciences, Faculty of Medicine, Lund University, Malmö, Sweden
- Department of Internal Medicine, Skåne University Hospital, Malmö, Sweden
| | - Mohammad Abdulrasak
- Department of Clinical Sciences, Faculty of Medicine, Lund University, Malmö, Sweden
- Department of Internal Medicine, Section of Gastroenterology, Skåne University Hospital, Malmö, Sweden
| | - Martin Malina
- West London Vascular and Interventional Centre, Northwick Park University Hospital, Harrow, UK
| | - Timothy Resch
- Department of Vascular Surgery, Rigshospitalet, Copenhagen, Denmark
- Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark
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Ye M, Ni Q, Zhu Y, Du Y, Wang Y, Guo X, Zhang L, Feng Z. Stent Graft vs Drug-Coated Balloon in Endovascular Treatment of Complex Femoropopliteal Artery Lesions: A 2-Center Experience. J Endovasc Ther 2023:15266028231201097. [PMID: 37728023 DOI: 10.1177/15266028231201097] [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: 09/21/2023]
Abstract
OBJECTIVE Both stent grafts (SG) and drug-coated balloons (DCBs) have shown to be effective treatments for long and complex femoropopliteal (FP) lesions. However, there has not been a clinical trial comparing the 2 treatments directly. This study aims to compare the primary patency (PP) and clinical outcomes of SG and DCB for endovascular treatment of complex FP Trans-Atlantic Inter-Society Consensus (TASC) C/D lesions in patients. METHODS From July 2013 to May 2019, a retrospective study was conducted at 2 medical centers to compare the clinical outcomes of Viabahn SG and DCB angioplasty in patients with TASC C/D FP lesions. The study used overlap weighting to adjust for differences in baseline characteristics and to reduce the impact of confounding factors and selection bias between the 2 groups. The primary endpoint was PP through 24 months, and the secondary endpoints included freedom from clinical-driven target lesion revascularization (CD-TLR), all-cause of death rate, and major amputation rate. RESULTS A total of 161 limbs in 150 patients with TASC C/D FP lesions were treated either with Viabahn SGs (67 limbs, 65 patients) or DCBs (94 limbs, 85 patients). In the DCB group, 22 target vessels (23.4%) underwent directional atherectomy before DCB angioplasty and 37 target vessels (39.4%) underwent bail-out bare-metal stent implantation for early recoil or severe dissection. The SG group had significantly higher PP rates at both the 12 and 24 months than in the DCB group (75.8% vs 39.2%, p=0.02; 64.1% vs 31.9%, p=0.02), respectively. However, there were no significant differences between the 2 groups in terms of CD-TLR, death rate, and major amputation rate. According to the results of multivariate analysis, DCB angioplasty was the only independent predictor associated with restenosis (hazard ratio [HR]=0.264, 95% confidence interval [CI]=0.100-0.696, p=0.007). CONCLUSIONS This study showed that SG was associated with a significantly higher PP rate in complex long FP lesions compared with DCB angioplasty. However, there was no significant difference in the freedom from CD-TLR and major amputation rate. It is important to follow the criteria for using SG strictly to avoid early restenosis, which can lead to acute thrombosis and severe limb ischemia. Closer monitoring is recommended for patients who undergo SG implantation. CLINICAL IMPACT There has no head-to-head clinical trial that compares DCB and SG in complex long FP lesions. This study showed that SG following the criteria was associated with a significantly higher PP rate compared with DCB angioplasty. Closer monitoring is recommended for patients with SG to avoid acute thrombosis. Randomized controlled trials comparing SG and DCB are necessary.
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Affiliation(s)
- Meng Ye
- Department of Vascular Surgery, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China
| | - Qihong Ni
- Department of Vascular Surgery, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China
| | - Youpeng Zhu
- Department of Vascular Surgery, Liyuan Hospital Affiliated Tongji Medical Collage of Huazhong University of Science & Technology, Wuhan, China
| | - Ye Du
- Department of Vascular Surgery, Liyuan Hospital Affiliated Tongji Medical Collage of Huazhong University of Science & Technology, Wuhan, China
| | - Yuli Wang
- Department of Vascular Surgery, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China
| | - Xiangjiang Guo
- Department of Vascular Surgery, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China
| | - Lan Zhang
- Department of Vascular Surgery, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China
| | - Zibo Feng
- Department of Vascular Surgery, Liyuan Hospital Affiliated Tongji Medical Collage of Huazhong University of Science & Technology, Wuhan, China
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Zenunaj G, Acciarri P, Baldazzi G, Cosacco AM, Gasbarro V, Traina L. Endovascular Revascularisation versus Open Surgery with Prosthetic Bypass for Femoro-Popliteal Lesions in Patients with Peripheral Arterial Disease. J Clin Med 2023; 12:5978. [PMID: 37762924 PMCID: PMC10532352 DOI: 10.3390/jcm12185978] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/05/2023] [Revised: 09/12/2023] [Accepted: 09/13/2023] [Indexed: 09/29/2023] Open
Abstract
Aim: Complex atherosclerotic femoro-popliteal lesions have traditionally been treated with bypass surgery. A prosthetic graft is used to save the vein graft for more distal revascularisations or when a vein graft is unavailable. The endovascular approach has gained popularity and is offered as a first-line strategy for complex lesions. This study aimed to evaluate whether endovascular procedures can be used as a first-line treatment strategy for complex native femoro-popliteal lesions over open surgery with prosthetic bypass in patients with peripheral arterial disease (PAD). Methods: This single-centre retrospective observational study was conducted between 2013 and 2021; it included patients with symptomatic PAD who required limb revascularisation at the femoro-popliteal segment and who had complex lesions. The primary endpoints analysed were technical success, primary patency, freedom from clinically driven target lesion revascularisation (cdTLR), freedom from major adverse limb and cardiovascular events (MALE and MACE, respectively), freedom from limb loss, and survival. The secondary endpoints were length of in-hospital stay, and duration and costs of the procedure. Results: We identified 185 limbs among 174 suitable candidates for comparison, wherein 105 were treated with an endovascular procedure and 80 with a femoro-popliteal prosthetic bypass. Most patients in both groups presented with chronic limb-threatening ischaemia, and >90% of them had an American Society of Anesthesiologists (ASA) physical status classification of >3. The endovascular group had more octogenarians (p = 0.02) and patients with coronary disease (p = 0.004). The median follow-up was 30 months. The technical failure rate for endovascular procedures was 4.7%, versus 0% in the open group (p = 0.047). Freedom from MACE was similar in both groups. The endovascular group showed superior primary patency (p < 0.0001), cdTLR (p < 0.0001), MALE (p < 0.0001), and freedom from limb loss (p = 0.0018) at 24 and 48 months. Further analysis performed for the open above-the-knee sub-group showed that the aforementioned endpoints were similar between the groups at 12 months and were better in the endovascular group at 24 and 48 months. Procedural time and in-hospital stay were longer in the open group than in the endovascular group (p < 0.0001 and p < 0.001, respectively). The procedural cost in the endovascular group was 10-fold lower than that in the prosthetic bypass group. Conclusions: Endovascular procedures are safe for treating complex femoro-popliteal lesions in patients at a high risk for surgery and show better outcomes at 24 months than prosthetic bypasses do. The latter may be considered as an alternative should endovascular treatment fail.
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Affiliation(s)
- Gladiol Zenunaj
- Unit of Vascular and Endovascular Surgery, University Hospital of Ferrara, 44124 Ferrara, Italy; (P.A.); (V.G.); (L.T.)
| | - Pierfilippo Acciarri
- Unit of Vascular and Endovascular Surgery, University Hospital of Ferrara, 44124 Ferrara, Italy; (P.A.); (V.G.); (L.T.)
| | - Giulia Baldazzi
- Department of Translational Medicine for Romagna, School of Vascular Surgery, University of Ferrara, 44121 Ferrara, Italy; (G.B.); (A.M.C.)
| | - Alessio Mario Cosacco
- Department of Translational Medicine for Romagna, School of Vascular Surgery, University of Ferrara, 44121 Ferrara, Italy; (G.B.); (A.M.C.)
| | - Vincenzo Gasbarro
- Unit of Vascular and Endovascular Surgery, University Hospital of Ferrara, 44124 Ferrara, Italy; (P.A.); (V.G.); (L.T.)
- Department of Translational Medicine for Romagna, School of Vascular Surgery, University of Ferrara, 44121 Ferrara, Italy; (G.B.); (A.M.C.)
| | - Luca Traina
- Unit of Vascular and Endovascular Surgery, University Hospital of Ferrara, 44124 Ferrara, Italy; (P.A.); (V.G.); (L.T.)
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Li MX, Tu HX, Yin MC. Meta-analysis of outcomes from drug-eluting stent implantation in infrapopliteal arteries. World J Clin Cases 2023; 11:5273-5287. [PMID: 37621588 PMCID: PMC10445070 DOI: 10.12998/wjcc.v11.i22.5273] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/05/2023] [Revised: 07/07/2023] [Accepted: 07/17/2023] [Indexed: 08/04/2023] Open
Abstract
BACKGROUND Percutaneous drug-eluting stent implantation (DESI) is an emerging and promising treatment modality for infrapopliteal artery diseases (IPADs). This systematic review and meta-analysis summarizes and quantitatively analyzes the outcomes of DESI in IPADs considering the hazard ratio (HR), which is a more accurate and appropriate outcome measure than the more commonly used relative risk and odds ratio. AIM To explore the superiority of drug-eluting stents (DESs) vs traditional treatment modalities for IPADs. METHODS The following postoperative indicators were the outcomes of interest: All-cause death (ACD)-free survival, major amputation (MA)-free survival, target lesion revascularization (TLR)-free survival, adverse event (AE)-free survival, and primary patency (PP) survival. The outcome measures were then compared according to their respective HRs with 95% confidence intervals (CIs). The participants were human IPAD patients who underwent treatments for infrapopliteal lesions. DESI was set as the intervention arm, and traditional percutaneous transluminal angioplasty (PTA) with or without bare metal stent implantation (BMSI) was set as the control arm. A systematic search in the Excerpta Medica Database (Embase), PubMed, Web of Science, and Cochrane Library was performed on November 29, 2022. All controlled studies published in English with sufficient data on outcomes of interest for extraction or conversion were included. When studies did not directly report the HRs but gave a corresponding survival curve, we utilized Engauge Digitizer software and standard formulas to convert the information and derive HRs. Then, meta-analyses were conducted using a random-effects model. RESULTS Five randomized controlled trials and three cohort studies involving 2639 participants were included. The ACD-free and MA-free survival HR values for DESI were not statistically significant from those of the control treatment (P > 0.05); however, the HR values for TLR-free, AE-free, and PP-survival differed significantly [2.65 (95%CI: 1.56-4.50), 1.57 (95%CI: 1.23-2.01), and 5.67 (95%CI: 3.56-9.03), respectively]. CONCLUSION Compared with traditional treatment modalities (i.e., PTA with or without BMSI), DESI for IPADs is superior in avoiding TLR and AEs and maintaining PP but shows no superiority or inferiority in avoiding ACD and MA.
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Affiliation(s)
- Ming-Xuan Li
- Department of Vascular Surgery, Beijing Fengtai You'anmen Hospital, Beijing 100069, China
| | - Hai-Xia Tu
- Department of Vascular Surgery, Beijing Fengtai You'anmen Hospital, Beijing 100069, China
| | - Meng-Chen Yin
- Department of Vascular Surgery, Beijing Fengtai You'anmen Hospital, Beijing 100069, China
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Li MX, Tu HX, Yin MC. Meta-analysis of outcomes from drug-eluting stent implantation in infrapopliteal arteries. World J Clin Cases 2023; 11:5267-5281. [DOI: 10.12998/wjcc.v11.i22.5267] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/05/2023] [Revised: 07/07/2023] [Accepted: 07/17/2023] [Indexed: 08/03/2023] Open
Abstract
BACKGROUND Percutaneous drug-eluting stent implantation (DESI) is an emerging and promising treatment modality for infrapopliteal artery diseases (IPADs). This systematic review and meta-analysis summarizes and quantitatively analyzes the outcomes of DESI in IPADs considering the hazard ratio (HR), which is a more accurate and appropriate outcome measure than the more commonly used relative risk and odds ratio.
AIM To explore the superiority of drug-eluting stents (DESs) vs traditional treatment modalities for IPADs.
METHODS The following postoperative indicators were the outcomes of interest: All-cause death (ACD)-free survival, major amputation (MA)-free survival, target lesion revascularization (TLR)-free survival, adverse event (AE)-free survival, and primary patency (PP) survival. The outcome measures were then compared according to their respective HRs with 95% confidence intervals (CIs). The participants were human IPAD patients who underwent treatments for infrapopliteal lesions. DESI was set as the intervention arm, and traditional percutaneous transluminal angioplasty (PTA) with or without bare metal stent implantation (BMSI) was set as the control arm. A systematic search in the Excerpta Medica Database (Embase), PubMed, Web of Science, and Cochrane Library was performed on November 29, 2022. All controlled studies published in English with sufficient data on outcomes of interest for extraction or conversion were included. When studies did not directly report the HRs but gave a corresponding survival curve, we utilized Engauge Digitizer software and standard formulas to convert the information and derive HRs. Then, meta-analyses were conducted using a random-effects model.
RESULTS Five randomized controlled trials and three cohort studies involving 2639 participants were included. The ACD-free and MA-free survival HR values for DESI were not statistically significant from those of the control treatment (P > 0.05); however, the HR values for TLR-free, AE-free, and PP-survival differed significantly [2.65 (95%CI: 1.56-4.50), 1.57 (95%CI: 1.23-2.01), and 5.67 (95%CI: 3.56-9.03), respectively].
CONCLUSION Compared with traditional treatment modalities (i.e., PTA with or without BMSI), DESI for IPADs is superior in avoiding TLR and AEs and maintaining PP but shows no superiority or inferiority in avoiding ACD and MA.
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Affiliation(s)
- Ming-Xuan Li
- Department of Vascular Surgery, Beijing Fengtai You'anmen Hospital, Beijing 100069, China
| | - Hai-Xia Tu
- Department of Vascular Surgery, Beijing Fengtai You'anmen Hospital, Beijing 100069, China
| | - Meng-Chen Yin
- Department of Vascular Surgery, Beijing Fengtai You'anmen Hospital, Beijing 100069, China
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40
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Yang C, Qian J, Dou KF, Li JJ. Drug-Coated Balloons for Complex PAD: More Study Is Needed. JACC Cardiovasc Interv 2023; 16:1822-1823. [PMID: 37495359 DOI: 10.1016/j.jcin.2023.05.034] [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: 05/22/2023] [Accepted: 05/23/2023] [Indexed: 07/28/2023]
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41
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Altin SE, Parise H, Hess CN, Rosenthal NA, Creager MA, Aronow HD, Curtis JP. Long-Term Patient Outcomes After Femoropopliteal Peripheral Vascular Intervention in Patients With Intermittent Claudication. JACC Cardiovasc Interv 2023; 16:1668-1678. [PMID: 37438035 DOI: 10.1016/j.jcin.2023.05.001] [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: 10/06/2022] [Revised: 05/01/2023] [Accepted: 05/02/2023] [Indexed: 07/14/2023]
Abstract
BACKGROUND In patients with intermittent claudication (IC), short-term amputation rates from clinical trial data following lower extremity femoropopliteal (FP) peripheral vascular intervention (PVI) are <1% with unknown longer-term rates. OBJECTIVES The aim of this study was to identify revascularization and amputation rates following PVI in the FP segment and to assess 4-year amputation and revascularization rates after FP PVI for IC. METHODS From 2016 to 2020, 19,324 patients undergoing FP PVI for IC were included from the PINC AI Healthcare Database and evaluated by treatment level (superficial femoral artery [SFA], popliteal artery [POP], or both). The primary outcome was index limb amputation (ILA) assessed by Kaplan-Meier estimate. The secondary outcomes were index limb major amputation and repeat revascularization. HRs were estimated using Cox proportional hazard regression. RESULTS The 4-year index limb amputation rate following FP PVI was 4.3% (95% CI: 4.0-4.7), with a major amputation rate of 3.2% (95% CI: 2.9-3.5). After POP PVI, ILA was significantly higher than SFA alone (7.5% vs 3.4%) or both segment PVI (5.5%). In multivariate analysis, POP PVI was associated with higher ILA rates at 4 years compared with isolated SFA PVI (HR: 2.10; 95% CI: 1.52-2.91) and index limb major amputation (HR: 1.98; 95% CI: 1.32-2.95). Repeat FP revascularization rates were 15.2%; they were highest in patients undergoing both SFA and POP PVI (18.7%; P < 0.0001) compared with SFA (13.9%) and POP (17.1%) only. CONCLUSIONS IC patients undergoing FP PVI had 4-year rates of index limb repeat revascularization of 16.7% and ILA rates of 4.3%. Further risk factors for amputation requires further investigation.
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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, USA; West Haven Veterans Affairs Medical Center, West Haven, Connecticut, USA.
| | - Helen Parise
- Section of Cardiovascular Medicine, Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut, USA
| | - Connie N Hess
- Division of Cardiology, Department of Medicine, University of Colorado School of Medicine, Aurora, Colorado, USA; Colorado Prevention Center Clinical Research, Aurora, Colorado, USA
| | - Ning A Rosenthal
- Premier, Inc, PINC AI Applied Sciences, Charlotte, North Carolina, USA
| | - Mark A Creager
- Heart and Vascular Center, Dartmouth-Hitchcock Medical Center and Geisel School of Medicine at Dartmouth, Lebanon, New Hampshire, USA
| | | | - Jeptha P Curtis
- Section of Cardiovascular Medicine, Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut, USA; Center for Outcomes Research and Evaluation, Yale New Haven Hospital, New Haven, Connecticut, USA
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Lee SJ, Lee HH, Ko YG, Ahn CM, Lee YJ, Kim JS, Kim BK, Hong MK, Chang Kim H, Yu CW, Lee JH, Lee SW, Youn YJ, Park JK, Yoon CH, Rha SW, Min PK, Choi SH, Chae IH, Choi D. Device Effectiveness for Femoropopliteal Artery Disease Treatment: An Analysis of K-VIS ELLA Registry. JACC Cardiovasc Interv 2023; 16:1640-1650. [PMID: 37438031 DOI: 10.1016/j.jcin.2023.05.002] [Citation(s) in RCA: 7] [Impact Index Per Article: 3.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/21/2023] [Revised: 04/28/2023] [Accepted: 05/02/2023] [Indexed: 07/14/2023]
Abstract
BACKGROUND Although drug-coated balloons (DCBs) and drug-eluting stents (DES) are frequently used for the treatment of femoropopliteal artery (FPA) disease, their mid- or long-term clinical efficacy in real-world practice is still limited. OBJECTIVES From the K-VIS ELLA (Korean Vascular Intervention Society Endovascular Therapy in Lower Limb Artery Diseases) multicenter registry cohort, clinical outcomes of drug-eluting devices for FPA lesions in comparison with bare-metal stents (BMS) were evaluated. METHODS Limbs that underwent percutaneous transluminal angioplasty for FPA lesions with plain old balloon angioplasty (POBA, n = 826), BMS (n = 943), DCBs (n = 778), or DES (n = 227) between 2012 and 2020 were included. The primary outcome was target lesion revascularization (TLR) at 2 years. Inverse probability of treatment weighting was used to account for confounding. RESULTS After inverse probability of treatment weighting, baseline characteristics were well-balanced among groups. Compared with the 2-year cumulative incidence of TLR with BMS (26.5%), the incidence of TLR was significantly lower in limbs treated with DCBs (15.9%; HR: 0.44; 95% CI: 0.30-0.64; P < 0.001) or DES (15.9%; HR: 0.51; 95% CI: 0.29-0.87; P = 0.014). No significant differences were observed in the risk of TLR between DCBs vs DES (HR: 0.87; 95% CI: 0.51-1.49; P = 0.613) and POBA vs BMS (HR: 0.94; 95% CI: 0.73-1.21; P = 0.626). All-cause mortality was comparable in the 4 groups. Treatment with DCBs showed a more pronounced favorable outcome in limbs with Trans-Atlantic Inter-Society Consensus II type C/D lesions or long lesions (≥150 mm) compared with POBA, BMS, or DES (Pinteraction< 0.05). CONCLUSIONS In real-world practice, DCBs and DES demonstrated comparably superior midterm outcomes over POBA or BMS in the treatment of FPA lesions.
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Affiliation(s)
- Seung-Jun Lee
- Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Korea
| | - Hyeok-Hee Lee
- Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Korea; Department of Preventive Medicine, Yonsei University College of Medicine, Seoul, Korea
| | - Young-Guk Ko
- Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Korea.
| | - Chul-Min Ahn
- Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Korea
| | - Yong-Joon Lee
- Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Korea
| | - Jung-Sun Kim
- Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Korea
| | - Byeong-Keuk Kim
- Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Korea
| | - Myeong-Ki Hong
- Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Korea
| | - Hyeon Chang Kim
- Department of Preventive Medicine, Yonsei University College of Medicine, Seoul, Korea
| | - Cheol Woong Yu
- Department of Cardiology, Cardiovascular Center, Korea University Anam Hospital, Korea University College of Medicine, Seoul, Republic of Korea
| | - Jae-Hwan Lee
- Cardiovascular Center, Department of Cardiology in Internal Medicine, Chungnam National University Sejong Hospital, Chungnam National University School of Medicine, Daejeon, South Korea
| | - Seung-Whan Lee
- Division of Cardiology, University of Ulsan, Asan Medical Center, Seoul, Korea
| | - Young Jin Youn
- Division of Cardiology, Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju, Korea
| | - Jong Kwan Park
- Division of Cardiology, Department of Internal Medicine, National Health Insurance Service Ilsan Hospital, Goyang, Korea
| | - Chang-Hwan Yoon
- Department of Internal Medicine, Seoul National University College of Medicine, Seoul, South Korea; Department of Cardiology, Seoul National University Bundang Hospital, Seongnam, South Korea
| | - Seung Woon Rha
- Cardiovascular Center, Division of Cardiology, Department of Internal Medicine, Korea University Guro Hospital, Korea University College of Medicine, Seoul, Korea
| | - Pil-Ki Min
- Division of Cardiology, Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea
| | - Seung-Hyuk Choi
- Division of Cardiology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea
| | - In-Ho Chae
- Department of Internal Medicine, Seoul National University College of Medicine, Seoul, South Korea; Department of Cardiology, Seoul National University Bundang Hospital, Seongnam, South Korea
| | - Donghoon Choi
- Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Korea
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Liistro F. Is Drug-Coated Balloon the Real Winner for Femoropopliteal Artery Intervention? JACC Cardiovasc Interv 2023; 16:1651-1653. [PMID: 37438032 DOI: 10.1016/j.jcin.2023.05.048] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/23/2023] [Accepted: 05/30/2023] [Indexed: 07/14/2023]
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El Khoury R, Tzvetanov I, Estrada EA, McCarroll E, Goor JB, Guy LG, Laflamme M, Schwartz LB. Drug-eluting, balloon-expandable, bioresorbable vascular scaffolds reduce neointimal thickness and stenosis in an animal model of percutaneous peripheral intervention. JVS Vasc Sci 2023; 4:100114. [PMID: 37546529 PMCID: PMC10403740 DOI: 10.1016/j.jvssci.2023.100114] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/20/2023] [Accepted: 05/31/2023] [Indexed: 08/08/2023] Open
Abstract
Objective Recanalization with balloon angioplasty and/or self-expanding stents (SES) has become the endovascular treatment of choice for symptomatic femoropopliteal occlusive disease. These strategies generate suboptimal clinical results, however, because they fail to expand the artery fully and ineffectively prevent recoil, neointimal hyperplasia, and restenosis. Balloon-expandable stents, given their greater radial force and rigid structure, represent a more effective treatment strategy, but only short lengths can be implanted safely in arteries that deform and bend with skeletal motion. The purpose of this preclinical experiment was to test the hypothesis that simultaneous implantation of a series of short, resorbable, balloon-expandable, paclitaxel-eluting scaffolds would prevent neointimal hyperplasia and stenosis compared with SES in an animal model of percutaneous femoropopliteal intervention. Methods We extruded 6 × 60 mm Efemoral Vascular Scaffold Systems (EVSS) from copolymers of poly-L-lactic acid, coated with paclitaxel 3 μg/mm2, crimped onto a single delivery balloon, and implanted percutaneously into the iliofemoral arteries of eight Yucatan mini-swine. We implanted 7- to 8-mm × 60 mm SES into the contralateral experimental arteries. The animals were serially imaged with contrast angiography and optical coherence tomography after 30, 90, 180, 365, and 730 days. The primary end point of this study was neointimal morphometry over time. Secondary end points included acute deformation and angiographic and optical coherence tomography-derived measurements of chronic vascular response. Results Over the 2-year study period, one SES was found to be completely occluded at 90 days; all EVSS were widely patent at all time points. Arteries treated with SES exhibited profound neointimal hyperplasia with in-stent stenosis. In contrast, arteries treated with EVSS exhibited only modest vascular responses and minimal stenosis. After 2 years, the mean neointimal thickness (0.45 ± 0.12 vs 1.31 ± 0.91 mm; P < .05) and area (8.41 ± 3.35 vs 21.86 ± 7.37 mm2; P < .05) were significantly decreased after EVSS implantation. By 2 years, all scaffolds in all EVSS-treated arteries had resorbed fully. Conclusions In this preclinical animal model of peripheral endovascular intervention, the EVSS decreased neointimal hyperplasia and stenosis significantly compared with SES, then dissolved completely between the first and second years after implantation.
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Affiliation(s)
| | | | | | | | | | | | | | - Lewis B. Schwartz
- Efemoral Medical, Inc., Los Altos, CA
- Department of Surgery, Advocate Lutheran General Hospital, Park Ridge, IL
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Li C, Chen H, Wang M, Zhang S, Jiang Y, Xian Z, Shen C, Guo J, Song C, Gong H, Ye N, Zhao X. Preliminary studies on intimal injury related to stent retrieval in a canine model. Biochem Biophys Res Commun 2023; 670:102-108. [PMID: 37290284 DOI: 10.1016/j.bbrc.2023.05.122] [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: 04/24/2023] [Revised: 05/09/2023] [Accepted: 05/30/2023] [Indexed: 06/10/2023]
Abstract
OBJECTIVE This pilot study aimed to observe intimal injuries related to stent retrieval in the iliac artery of a canine. BACKGROUND In-stent restenosis remains challenging owing to permanent stent implantation. A retrievable stent may be alternative for intervention without permanent residue. METHODS Five retrievable stents with point-to-point overlapped double-layer scaffolds were deployed into the iliac arteries and retrieved on days 14, 21, 28, 35, and 42 from five canines. RESULTS Arterial diameter decreased by 9-10% before retrieval and 15% on day 14 after retrieval. In the 14-day-stent, the stent surface was clean without visible fibrin. In the 28-day-stent, the overlay was mainly composed of fibrin and fibroblasts. The proliferation of smooth muscle cells has not yet been observed with α-smooth muscle actin staining. In the 42-day-stent, endothelial and smooth muscle cells decreased under the struts, and the internal elastic lamina was interrupted segmentally. Neointima formation involves fibroblasts and smooth muscle cells. Neointimal thickness was negatively correlated with strut space. Stent traces on the artery wall tended to be flat at a follow-up14 days after retrieval. The primary intima was completely covered by neointima. Two stents could not be retrieved because of in-stent thrombosis or capture loss. CONCLUSIONS The stent was covered mainly by depositional fibrin after 28 days and by typical neointima after 42 days. The stent retrieval procedure did not induce injury to vascular smooth muscle, and the intima repair was performed 14 days after stent retrieval.
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Affiliation(s)
- Cong Li
- Cardiology, The Third Affiliated Hospital of the Second Military Medical University, Shanghai, 201805, China, The Medical College of Soochow University
| | - Houliang Chen
- Cardiology, The Third Affiliated Hospital of the Second Military Medical University, Shanghai, 201805, China, The Medical College of Soochow University
| | - Minghong Wang
- Cardiology, The Third Affiliated Hospital of the Second Military Medical University, Shanghai, 201805, China, The Medical College of Soochow University
| | - Shujie Zhang
- Cardiology, The Third Affiliated Hospital of the Second Military Medical University, Shanghai, 201805, China, The Medical College of Soochow University
| | - Yujuan Jiang
- Cardiology, The Third Affiliated Hospital of the Second Military Medical University, Shanghai, 201805, China, The Medical College of Soochow University
| | - Zhihong Xian
- Pathology, The Third Affiliated Hospital of the Second Military Medical University, Shanghai, 201805, China
| | - Cuiqin Shen
- Ultrasonography, The Third Affiliated Hospital of the Second Military Medical University, Shanghai, 201805, China
| | - Jingzhen Guo
- Shanghai Institute for Minimally Invasive Therapy, School of Medical Instrument and Food Engineering, University of Shanghai for Science and Technology, Shanghai, 200093, China
| | - Chengli Song
- Shanghai Institute for Minimally Invasive Therapy, School of Medical Instrument and Food Engineering, University of Shanghai for Science and Technology, Shanghai, 200093, China
| | - Hui Gong
- Cardiology, Jin Shan Hospital, Fudan University, Shanghai, 201500, China
| | - Nan Ye
- Cardiology, Jin Shan Hospital, Fudan University, Shanghai, 201500, China
| | - Xue Zhao
- Cardiology, The Third Affiliated Hospital of the Second Military Medical University, Shanghai, 201805, China, The Medical College of Soochow University.
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46
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Müller A, Bradaric C, Kafka A, Joner M, Cassese S, Xhepa E, Kufner S, Kastrati A, Laugwitz KL, Ibrahim T, Koppara T. Prevalence and patterns of in-stent neoatherosclerosis in lower extremity artery disease. EUROINTERVENTION 2023; 18:1462-1470. [PMID: 36714952 PMCID: PMC10111128 DOI: 10.4244/eij-d-22-00615] [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: 07/14/2022] [Accepted: 10/12/2022] [Indexed: 01/31/2023]
Abstract
BACKGROUND In-stent restenosis (ISR) is responsible for a rapid decline of vessel patency after stenting. To date, little is known about the role of in-stent neoatherosclerosis (NA) in stent failure in lower limb arteries. AIMS This study aimed to determine the prevalence and patterns of in-stent NA in patients with symptomatic ISR of the lower extremity vasculature using intravascular optical coherence tomography (OCT) imaging. METHODS Patients underwent endovascular revascularisation for ISR including angiography and OCT imaging. NA was defined as the presence of at least 1 fibroatheroma or fibrocalcific plaque within the neointima of a stented segment. RESULTS Using OCT, we imaged 24 symptomatic patients with lower extremity artery disease (LEAD), with a total of 30 ISR in the lower limbs, prior to their scheduled endovascular interventions. NA formation was observed in 23 (76.7%) lesions, while all stents with an implant duration >5 years (n=8) showed signs of NA. The time from stent implantation to OCT was significantly increased in lesions with NA (p=0.002). Lesions without NA had a significantly shorter duration from index procedure to OCT than those with ≥50 percent (n=9; p=0.003) or <50 percent (n=14; p=0.015) of frames exhibiting signs of NA. NA was predominantly characterised by fibroatheroma with thick fibrous caps with or without calcification. CONCLUSIONS In-stent NA is frequently identified by OCT imaging after endovascular therapy in lower limb arteries; this increased both in frequency and extent the longer the duration since implantation. Our findings indicate an active atherosclerotic process that may need tailored mitigation strategies.
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Affiliation(s)
- Arne Müller
- Klinik und Poliklinik für Innere Medizin I, Klinikum rechts der Isar, Technische Universität München, Munich, Germany
| | - Christian Bradaric
- Klinik und Poliklinik für Innere Medizin I, Klinikum rechts der Isar, Technische Universität München, Munich, Germany
| | - Andre Kafka
- Klinik und Poliklinik für Innere Medizin I, Klinikum rechts der Isar, Technische Universität München, Munich, Germany
| | - Michael Joner
- Deutsches Herzzentrum München, Abteilung für Herz- und Kreislauferkrankungen, Technische Universität München, Munich, Germany
- DZHK (German Centre for Cardiovascular Research), partner site Munich Heart Alliance, Munich, Germany
| | - Salvatore Cassese
- Deutsches Herzzentrum München, Abteilung für Herz- und Kreislauferkrankungen, Technische Universität München, Munich, Germany
| | - Erion Xhepa
- Deutsches Herzzentrum München, Abteilung für Herz- und Kreislauferkrankungen, Technische Universität München, Munich, Germany
| | - Sebastian Kufner
- Deutsches Herzzentrum München, Abteilung für Herz- und Kreislauferkrankungen, Technische Universität München, Munich, Germany
| | - Adnan Kastrati
- Deutsches Herzzentrum München, Abteilung für Herz- und Kreislauferkrankungen, Technische Universität München, Munich, Germany
- DZHK (German Centre for Cardiovascular Research), partner site Munich Heart Alliance, Munich, Germany
| | - Karl-Ludwig Laugwitz
- Klinik und Poliklinik für Innere Medizin I, Klinikum rechts der Isar, Technische Universität München, Munich, Germany
- DZHK (German Centre for Cardiovascular Research), partner site Munich Heart Alliance, Munich, Germany
| | - Tareq Ibrahim
- Klinik und Poliklinik für Innere Medizin I, Klinikum rechts der Isar, Technische Universität München, Munich, Germany
| | - Tobias Koppara
- Klinik und Poliklinik für Innere Medizin I, Klinikum rechts der Isar, Technische Universität München, Munich, Germany
- DZHK (German Centre for Cardiovascular Research), partner site Munich Heart Alliance, Munich, Germany
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47
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Fong KY, Xin L, Ng J, Loh SEK, Ng JJ, Choong AMTL. A systematic review and meta-analysis of sirolimus-eluting stents for treatment of below-the-knee arterial disease. J Vasc Surg 2023; 77:1264-1273.e3. [PMID: 36183989 DOI: 10.1016/j.jvs.2022.09.022] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/25/2022] [Revised: 08/29/2022] [Accepted: 09/19/2022] [Indexed: 10/14/2022]
Abstract
OBJECTIVE We performed a systematic review and meta-analysis to analyze the efficacy and safety of sirolimus-eluting stents (SESs) in the treatment of below-the-knee (BTK) arterial disease. METHODS An electronic literature search was conducted from inception to July 24, 2021. Retrospective, prospective, and randomized studies that had used SESs to treat BTK arterial disease and had reported the primary patency, technical success, target lesion revascularization, and/or mortality were included. Meta-analyses of the proportions were conducted to derive pooled summary statistics of the outcomes. Where Kaplan-Meier curves were provided for primary patency, a meta-analysis of the individual patient data was conducted via a graphic reconstruction tool to estimate primary patency at various follow-up points. For studies comparing SESs and bare metal stents (BMSs), a two-stage meta-analysis was performed to compare the 6-month primary patency of SESs vs BMSs. RESULTS Ten studies across 13 publications, including 995 patients, were retrieved for analysis. In the meta-analysis of proportions, across six studies (n = 339 patients), the pooled 6-month primary patency was 87.3% (95% confidence interval [CI], 81.6%-92.1%). Across seven studies (n = 283 patients), the pooled 6-month mortality was 5.4% (95% CI, 1.4%-11.2%). An individual patient data analysis of three studies (n = 282 patients) yielded a primary patency rate of 95.2% (95% CI, 92.7%-97.8%), 82.8% (95% CI, 78.3%-87.6%), 79.8% (95% CI, 75.0%-85.0%), and 79.8% (95% CI, 75.0%-85.0%) at 6, 12, 18, and 24 months, respectively. The 12-month target lesion revascularization rate across four studies (n = 324 patients) was 9.6% (95% CI, 6.4%-13.4%). In the two-stage meta-analysis of 6-month primary patency across three studies (n = 168 patients), the use of SESs was significantly favored over BMSs (risk ratio, 1.28; 95% CI, 1.12-1.46; P < .001). CONCLUSIONS The overall evidence suggests that the use of SESs appears to be safe and offers favorable outcomes for BTK arterial disease compared with BMSs.
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Affiliation(s)
- Khi Yung Fong
- Yong Loo Lin School of Medicine, National University of Singapore, Singapore; SingVaSC, Singapore Vascular Surgical Collaborative, Singapore
| | - Liu Xin
- SingVaSC, Singapore Vascular Surgical Collaborative, Singapore; Magdalen College, University of Oxford, Oxford, UK
| | - Josiah Ng
- Yong Loo Lin School of Medicine, National University of Singapore, Singapore; SingVaSC, Singapore Vascular Surgical Collaborative, Singapore
| | - Stanley E K Loh
- SingVaSC, Singapore Vascular Surgical Collaborative, Singapore; Department of Diagnostic Imaging, National University Health System, Singapore
| | - Jun Jie Ng
- SingVaSC, Singapore Vascular Surgical Collaborative, Singapore; Department of Surgery, Yong Loo Lin School of Medicine, National University of Singapore, Singapore; Division of Vascular and Endovascular Surgery, National University Heart Centre, Singapore
| | - Andrew M T L Choong
- SingVaSC, Singapore Vascular Surgical Collaborative, Singapore; Department of Surgery, Yong Loo Lin School of Medicine, National University of Singapore, Singapore; Division of Vascular and Endovascular Surgery, National University Heart Centre, Singapore; Cardiovascular Research Institute, National University of Singapore, Singapore.
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48
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Keefe N, Shull T, Botea L, McGinigle K. Drug-Coated Balloon versus Drug-Eluting Stent: The Debate of Leave Nothing Behind. Semin Intervent Radiol 2023; 40:161-166. [PMID: 37333737 PMCID: PMC10275675 DOI: 10.1055/s-0043-57261] [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: 06/20/2023]
Abstract
Endovascular techniques for peripheral artery disease have changed significantly in the past 10 years with advances in technology and data. Treatment of superficial femoral disease is complex secondary to the length, degree of calcification, high rate of chronic total occlusion, and areas of flexion within this vessel. Use of drug-coated devices has increased the interventionalist's toolbox with the objective to improve freedom from target lesion revascularization and primary patency. There remains debate as to which devices may reach these goals while also limiting overall morbidity and mortality. This article aims to highlight recent advances in the literature regarding the use of drug-coated devices.
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Affiliation(s)
- Nicole Keefe
- Department of Radiology, University of North Carolina School of Medicine, Chapel Hill, North Carolina
| | - Trevor Shull
- Department of Radiology, University of North Carolina School of Medicine, Chapel Hill, North Carolina
| | - Lev Botea
- Department of Vascular Surgery, University of North Carolina School of Medicine, Chapel Hill, North Carolina
| | - Katharine McGinigle
- Department of Vascular Surgery, University of North Carolina School of Medicine, Chapel Hill, North Carolina
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49
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Piorkowski M, Zeller T, Rammos C, Deloose K, Hertting K, Sesselmann V, Tepe G, Gaines P, Lichtenberg M. BioMimics 3D Stent in Femoropopliteal Lesions: 3-Year Outcomes with Propensity Matching for Drug-Coated Balloons. J Cardiovasc Dev Dis 2023; 10:jcdd10030126. [PMID: 36975890 PMCID: PMC10051351 DOI: 10.3390/jcdd10030126] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/28/2023] [Revised: 03/10/2023] [Accepted: 03/14/2023] [Indexed: 03/18/2023] Open
Abstract
Background: Through its helical centreline geometry, the BioMimics 3D vascular stent system is designed for the mobile femoropopliteal region, aiming to improve long-term patency and the risk of stent fractures. Methods: MIMICS 3D is a prospective, European, multi-centre, observational registry to evaluate the BioMimics 3D stent in a real-world population through 3 years. A propensity-matched comparison was performed to investigate the effect of the additional use of drug-coated balloons (DCB). Results: The MIMICS 3D registry enrolled 507 patients (518 lesion, length 125.9 ± 91.0 mm). At 3 years, the overall survival was 85.2%, freedom from major amputation 98.5%, freedom from clinically driven target lesion revascularisation 78.0%, and primary patency 70.2%. The propensity-matched cohort included 195 patients in each cohort. At 3-year follow-up, there was no statistically significant difference in clinical outcomes, such as overall survival (87.9% in the DCB vs. 85.1% in the no DCB group), freedom from major amputation (99.4% vs. 97.2%), clinically driven TLR (76.4% vs. 80.3%), and primary patency (68.5% vs. 74.4%). Conclusion: The MIMICS 3D registry showed good 3-year outcomes of the BioMimics 3D stent in femoropopliteal lesions, demonstrating the safety and performance of this device under real-world conditions, whether used alone or in combination with a DCB.
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Affiliation(s)
- Michael Piorkowski
- Department of Vascular Medicine, Cardioangiologic Center Bethanien, 60389 Frankfurt, Germany
- Correspondence: ; Tel.: +49-69-945028-0
| | - Thomas Zeller
- Department of Angiology, Universitätsklinikum Freiburg Herzzentrum, 79189 Bad Krozingen, Germany
| | - Christos Rammos
- Department of Cardiology and Vascular Medicine, West German Heart and Vascular Center Essen, University Hospital Essen, 45147 Essen, Germany
| | - Koen Deloose
- Department Vascular Surgery, AZ Sint-Blasius Dendermonde, Kroonveldlaan 50, 9200 Dendermonde, Belgium
| | - Klaus Hertting
- Department of Cardiology and Angiology, Krankenhaus Buchholz und Winsen gGmbH, 21423 Buchholz, Germany
| | - Volker Sesselmann
- Department of Angiology, SRH Zentralklinikum Suhl GmbH, 98527 Suhl, Germany
| | - Gunnar Tepe
- Department of Diagnostic and Interventional Radiology, RoMed Klinikum Rosenheim, 83022 Rosenheim, Germany
| | - Peter Gaines
- College of Health, Wellbeing and Life Sciences, Sheffield Hallam University, Sheffield S1 1WB, UK
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50
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Koeckerling D, Raguindin PF, Kastrati L, Bernhard S, Barker J, Quiroga Centeno AC, Raeisi-Dehkordi H, Khatami F, Niehot C, Lejay A, Szeberin Z, Behrendt CA, Nordanstig J, Muka T, Baumgartner I. Endovascular revascularization strategies for aortoiliac and femoropopliteal artery disease: a meta-analysis. Eur Heart J 2023; 44:935-950. [PMID: 36721954 PMCID: PMC10011342 DOI: 10.1093/eurheartj/ehac722] [Citation(s) in RCA: 21] [Impact Index Per Article: 10.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/18/2022] [Revised: 10/24/2022] [Accepted: 11/22/2022] [Indexed: 02/02/2023] Open
Abstract
AIMS Optimal endovascular management of intermittent claudication (IC) remains disputed. This systematic review and meta-analysis compares efficacy and safety outcomes for balloon angioplasty (BA), bare-metal stents (BMS), drug-coated balloons (DCB), drug-eluting stents (DES), covered stents, and atherectomy. METHODS AND RESULTS Electronic databases were searched for randomized, controlled trials (RCT) from inception through November 2021. Efficacy outcomes were primary patency, target-lesion revascularization (TLR), and quality-of-life (QoL). Safety endpoints were all-cause mortality and major amputation. Outcomes were evaluated at short-term (<1 year), mid-term (1-2 years), and long-term (≥2 years) follow-up. The study was registered on PROSPERO (CRD42021292639). Fifty-one RCTs enrolling 8430 patients/lesions were included. In femoropopliteal disease of low-to-intermediate complexity, DCBs were associated with higher likelihood of primary patency [short-term: odds ratio (OR) 3.21, 95% confidence interval (CI) 2.44-4.24; long-term: OR 2.47, 95% CI 1.93-3.16], lower TLR (short-term: OR 0.33, 95% CI 0.22-0.49; long-term: OR 0.42, 95% CI 0.29-0.60) and similar all-cause mortality risk, compared with BA. Primary stenting using BMS was associated with improved short-to-mid-term patency and TLR, but similar long-term efficacy compared with provisional stenting. Mid-term patency (OR 1.64, 95% CI 0.89-3.03) and TLR (OR 0.50, 95% CI 0.22-1.11) estimates were comparable for DES vs. BMS. Atherectomy, used independently or adjunctively, was not associated with efficacy benefits compared with drug-coated and uncoated angioplasty, or stenting approaches. Paucity and heterogeneity of data precluded pooled analysis for aortoiliac disease and QoL endpoints. CONCLUSION Certain devices may provide benefits in femoropopliteal disease, but comparative data in aortoiliac arteries is lacking. Gaps in evidence quantity and quality impede identification of the optimal endovascular approach to IC.
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Affiliation(s)
- David Koeckerling
- Division of Angiology, Swiss Cardiovascular Center, Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 18, 3010 Bern, Switzerland
| | - Peter Francis Raguindin
- Institute of Social and Preventive Medicine (ISPM), University of Bern, Mittelstrasse 43, 3012 Bern, Switzerland.,Swiss Paraplegic Research, Guido A. Zäch Str. 1, 6207 Nottwil, Switzerland.,Faculty of Health Sciences and Medicine, University of Lucerne, Frohburgstrasse, 36002 Lucerne, Switzerland
| | - Lum Kastrati
- Institute of Social and Preventive Medicine (ISPM), University of Bern, Mittelstrasse 43, 3012 Bern, Switzerland.,Graduate School for Health Sciences, University of Bern, Mittelstrasse 43, 3012 Bern, Switzerland.,Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 18, 3010 Bern, Switzerland
| | - Sarah Bernhard
- Division of Angiology, Swiss Cardiovascular Center, Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 18, 3010 Bern, Switzerland
| | - Joseph Barker
- Department of Cardiovascular Sciences, University of Leicester, University Rd, Leicestershire LE1 7RH, UK
| | | | - Hamidreza Raeisi-Dehkordi
- Institute of Social and Preventive Medicine (ISPM), University of Bern, Mittelstrasse 43, 3012 Bern, Switzerland.,Graduate School for Health Sciences, University of Bern, Mittelstrasse 43, 3012 Bern, Switzerland
| | - Farnaz Khatami
- Institute of Social and Preventive Medicine (ISPM), University of Bern, Mittelstrasse 43, 3012 Bern, Switzerland.,Community Medicine Department, Tehran University of Medical Sciences, PourSina St., Tehran 1417613151, Iran
| | - Christa Niehot
- Literature Searches Support, 3314SC Dordrecht, the Netherlands
| | - Anne Lejay
- Department of Vascular Surgery and Kidney Transplantation, University of Strasbourg, 4 rue Kirschleger, 67085 Strasbourg, France
| | - Zoltan Szeberin
- Department of Vascular Surgery, Semmelweis University, XII. Városmajor u. 68., 1122 Budapest, Hungary
| | - Christian-Alexander Behrendt
- Department of Vascular and Endovascular Surgery, Asklepios Clinic Wandsbek, Asklepios Medical School, Alphonsstraße 14, 22043 Hamburg, Germany
| | - Joakim Nordanstig
- Department of Vascular Surgery and Institute of Medicine, Department of Molecular and Clinical Medicine, Sahlgrenska University Hospital and Academy, Gothenburg University, Blå stråket 5, 413 45 Gothenburg, Sweden
| | - Taulant Muka
- Institute of Social and Preventive Medicine (ISPM), University of Bern, Mittelstrasse 43, 3012 Bern, Switzerland.,Epistudia, 3011 Bern, Switzerland
| | - Iris Baumgartner
- Division of Angiology, Swiss Cardiovascular Center, Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 18, 3010 Bern, Switzerland
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