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Micari A, Micari A, Virga V, Costa F, Di Bella G, Roscitano G, Versace A, Vadalà G, Vizzari G. Current insights into drug-coated balloons for peripheral arterial disease. Expert Opin Drug Deliv 2025; 22:629-637. [PMID: 40052958 DOI: 10.1080/17425247.2025.2476043] [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: 10/14/2024] [Accepted: 03/03/2025] [Indexed: 03/14/2025]
Abstract
INTRODUCTION Peripheral artery disease (PAD) is a manifestation of systemic atherosclerosis. It is often associated with coronary and/or cerebral vascular involvement, leading to a higher risk of cardiovascular and cerebrovascular events, among which myocardial infarction, stroke, and death. Cardiovascular prevention has proven effective in reducing the progression of the disease and early diagnosis leads to more rapid initiation of medical therapy. However, revascularization of the diseased segment represents the only solution in the manifest and symptomatic forms of the disease. AREAS COVERED Surgical treatment has historically represented the first treatment of PAD, which consists in the creation of bypasses excluding the obstructed segment. Nowadays, endovascular treatment represents in many cases the first line of intervention. Drug-coated balloons are a cornerstone solution for the treatment of peripheral lesions and are supported by multiple trials demonstrating their efficacy and safety. EXPERT OPINION New devices, such as sirolimus-eluting balloons, and also new eluting technologies will further improve the efficacy and the results of peripheral angioplasty. In the next years, we will experience the routinary use of new techniques currently under study. In this review, we will discuss the role of drug-coated balloons in the treatment of PAD.
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Affiliation(s)
- Antonio Micari
- Cardiology Unit, Department of Clinical and Experimental Medicine, University of Messina, Messina, Italy
| | - Antonino Micari
- Cardiology Unit, Department of Clinical and Experimental Medicine, University of Messina, Messina, Italy
| | - Vittorio Virga
- Cardiology Unit, Department of Clinical and Experimental Medicine, University of Messina, Messina, Italy
| | - Francesco Costa
- Cardiology and Cardiovascular Surgery Department, Virgen de la Victoria University Hospital, Málaga, Spain
| | - Gianluca Di Bella
- Cardiology Unit, Department of Clinical and Experimental Medicine, University of Messina, Messina, Italy
| | - Giuseppe Roscitano
- Department of General Surgery and Medical Specialties, University of Catania, Catania, Italy
| | - Antonio Versace
- Cardiology Unit, Department of Clinical and Experimental Medicine, University of Messina, Messina, Italy
| | - Giuseppe Vadalà
- Division of Cardiology, University Hospital Policlinico P. Giaccone, Palermo, Italy
| | - Giampiero Vizzari
- Cardiology Unit, Department of Clinical and Experimental Medicine, University of Messina, Messina, Italy
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Suriano M, Ritonga ITP, Donas KP, Austermann MJ, Usai MV. Drug Eluting Stents Below the Knee: Patency, Amputation-Rate, and Mortality-A Systematic Review of the Literature. J Endovasc Ther 2025:15266028251324809. [PMID: 40110974 DOI: 10.1177/15266028251324809] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 03/22/2025]
Abstract
BACKGROUND Numerous meta-analyses and multicenter randomized controlled trials have demonstrated that drug-eluting stents (DES) offer superior outcomes in terms of primary patency and limb salvage compared to other endovascular modalities such as balloon angioplasty and bare metal stents. This review aims to systematically analyze the literature on the clinical outcomes of DES for the treatment of infrapopliteal arterial occlusions. METHODS This study is a systematic review. Comprehensive searches were conducted in the MEDLINE, EMBASE, Ovid, Cochrane, DAR, and BVS databases. Eligible studies were those that reported outcomes of DES in the treatment of infrapopliteal arterial disease, with no restrictions on time frame, publication status, or language. The primary outcome assessed was the primary patency of the stent, while secondary outcomes included the rates of re-occlusion and mortality. RESULTS A total of 27 studies involving 2470 patients were included in the analysis, in which 1191 patients come from prospective multicenter studies. The mean age of the participants was 73.4 years. Approximately, 50% of the patients had diabetes mellitus and/or chronic renal failure, and 33.3% had heart disease. The fibular artery was the most frequently affected by stenosis, involved in 50.2% of cases, followed by the anterior tibial artery in 34.6% of cases and the posterior tibial artery in 15.2% of cases. The average patency rate following DES treatment was 72.2% at 12 months. The rate of re-occlusion was 21.6%, and the mortality rate was 16.6%. However, due to the heterogeneity of the sample and incomplete data, it was not possible to draw definitive correlations between patency, amputation rates, and mortality. CONCLUSION This systematic review and analysis revealed significant limitations due to the heterogeneity of the sample and incomplete data, preventing a comprehensive stratification of the findings. As a result, we are not yet able to fully address the research questions posed. Further studies with extended follow-up periods are needed to standardize the treatment of infrapopliteal arterial occlusions and provide more definitive conclusions.Clinical ImpactThis review assessed the efficacy and safety of drug-eluting stents for below-the-knee lesions, showing promising patency and safety results. Their use in daily practice may aid in treating lesions prone to recoil and dissection after angioplasty. Despite some data inconsistencies, the findings remain encouraging. Drug-eluting stents demonstrated better outcomes than Bare-metal Stent, supporting their consideration in clinical practice for below-the-knee vascular treatment.
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Affiliation(s)
- Marco Suriano
- Department of Vascular Surgery, St. Franziskus Hospital, Münster, Germany
| | - Imam T P Ritonga
- Department of Vascular Surgery, St. Franziskus Hospital, Münster, Germany
| | - Konstantinos P Donas
- Department of Vascular Surgery, Rhein Main Vascular Center, Asklepios Clinics Langen, Wiesbaden, Seligenstadt, Germany
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Chandra V, Lansky AJ, Sayfo S, Shammas NW, Soukas P, Park J, Siah M, Babaev A, Shields R, West NEJ, Armstrong E. Thirty-day outcomes from the Disrupt PAD BTK II study of the Shockwave Intravascular Lithotripsy System for treatment of calcified below-the-knee peripheral arterial disease. J Vasc Surg 2025; 81:710-719.e2. [PMID: 39536842 DOI: 10.1016/j.jvs.2024.11.003] [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: 09/06/2024] [Revised: 10/24/2024] [Accepted: 11/04/2024] [Indexed: 11/16/2024]
Abstract
BACKGROUND Below-the-knee (BTK) lesions may be particularly challenging to treat owing to length, diffuse disease, and extent of calcification. Landmark interventional clinical studies have not reached consensus on the optimal standard of care for BTK lesions, and many published trials excluded patients with moderate or severe lesion calcification. Calcium modification with intravascular lithotripsy (IVL) was shown to be superior to percutaneous transluminal angioplasty in the femoropopliteal artery and successful in treating BTK lesions in pilot studies. The Disrupt BTK II study is a core laboratory-adjudicated, prospective, multicenter, single-arm study of patients with moderate to severely calcified BTK lesions treated with the Shockwave Medical Peripheral IVL System. METHODS Disrupt BTK II enrolled 250 subjects with calcified infrapopliteal lesions and Rutherford category 3-5 presentation from 38 sites in the United States and Europe. The primary safety endpoint was major adverse limb events or postoperative death at 30 days, a composite of all-cause death, above-ankle amputation of the index limb, and/or major reintervention of the index limb involving an infrapopliteal artery. The primary effectiveness endpoint was procedural success, defined as ≤50% residual stenosis for all treated target lesions without serious core laboratory-adjudicated serious angiographic complications. The study used independent angiographic and duplex ultrasound core laboratories, and follow-up is planned through 2 years. RESULTS A total of 305 lesions in 250 patients were treated with a procedural success of 97.9%. The mean target lesion length was 76 ± 65 mm, diameter stenosis was 78% ± 18%, and 84.8% had moderate or severe calcification as assessed by an independent angiographic core laboratory. After IVL, residual stenosis was reduced to 29%, and after optional postdilatation and/or stent implantation, to 26%. At 30 days, there were no deaths, major adverse limb event rate was 0.8%, and mean improvement in Vascular Quality of Life scores was 4.0 ± 5.0 (P < .0001). Of the patients with baseline wounds, 15.8% healed and 53.4% were improved at 30 days. CONCLUSIONS The Disrupt PAD BTK II study demonstrated that treatment with the Shockwave Medical Peripheral IVL System in patients with moderate-severe calcified lesions resulted in high procedural success, significant reduction in residual stenosis, improvements in patient quality of life, and wound healing, with minimal adverse events at 30-day follow-up.
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Affiliation(s)
- Venita Chandra
- Department of Surgery, Stanford University Medical Center, Palo Alto, CA.
| | - Alexandra J Lansky
- Department of Cardiology, Yale Cardiovascular Research Group, New Haven, CT
| | - Sameh Sayfo
- Department of Interventional Cardiology, Baylor Scott and White, The Heart Hospital Plano, Plano, TX
| | - Nicolas W Shammas
- Division of Cardiology, Midwest Cardiovascular Research Foundation, Davenport, IA
| | - Peter Soukas
- Department of Interventional Cardiology, The Miriam Hospital-Cardiology Incorporated, Providence, RI
| | - James Park
- Department of Surgery, Texas Health Presbyterian Hospital, Dallas, TX
| | - Michael Siah
- Department of Surgery, Texas Health Presbyterian Hospital, Dallas, TX
| | - Anvar Babaev
- Department of Cardiology, NYU Langone Health, NY
| | - Ryan Shields
- Clinical Department, Shockwave Medical Inc., Santa Clara, CA
| | - Nick E J West
- Clinical Department, Shockwave Medical Inc., Santa Clara, CA
| | - Ehrin Armstrong
- Department of Interventional Cardiology, Advanced Heart and Vein Center, Thornton, CO
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Snyder DJ, Zilinyi RS, Kido T, Saleem D, Dreyfus I, Bruce S, Wadden E, Girvin Z, Finn MT, Kirtane AJ, Maehara A, Sethi SS, Parikh SA. The Impact of Intravascular Ultrasound Use on 1-Year Outcomes After Infrapopliteal Endovascular Intervention. JOURNAL OF THE SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY & INTERVENTIONS 2025; 4:102509. [PMID: 40231048 PMCID: PMC11993853 DOI: 10.1016/j.jscai.2024.102509] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Subscribe] [Scholar Register] [Received: 09/24/2024] [Revised: 12/06/2024] [Accepted: 12/10/2024] [Indexed: 04/16/2025]
Abstract
Background Data supporting the use of intravascular ultrasound (IVUS) in aortoiliac and femoropopliteal endovascular intervention are becoming increasingly robust, but data in the infrapopliteal circulation remain limited. The aim of this study was to evaluate the association between IVUS use and 1-year outcomes after infrapopliteal intervention. Methods All infrapopliteal endovascular interventions that occurred between 2018-2021 at a single academic medical center were retrospectively reviewed. Cases were separated into 2 cohorts based on the use of IVUS. Clinical characteristics, procedural data, and imaging were collected up to 1-year postintervention. The primary outcome of interest was 1-year binary restenosis. Secondary outcomes included rates of 1-year target lesion revascularization, amputation, major adverse limb events, and all-cause mortality. Results One hundred patients with 142 lesions were included. IVUS was used in 23% of cases. Baseline characteristics, lesion characteristics, and treatment modalities did not differ significantly between cohorts. At 1 year, cases with IVUS utilization had significantly lower rates of binary restenosis (22% vs 57%; P = .004) and substantially lower rates of target lesion revascularization (13% vs 33%; P = .06). Rates of amputation, major adverse limb events, and mortality did not differ significantly. In multivariate analysis, lesions treated with IVUS were significantly less likely to have binary restenosis at 1 year when compared with angiography alone (odds ratio, 0.18; 95% CI, 0.05-0.62; P = .007). Conclusions Intravascular ultrasound use was associated with lower rates of 1-year restenosis when compared to angiography alone, even after correcting for differences in clinical and procedural characteristics. These findings support the need for a prospective randomized trial evaluating the impact of IVUS use on outcomes after infrapopliteal endovascular intervention.
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Affiliation(s)
- Daniel J. Snyder
- Division of Cardiology, Department of Medicine, Columbia University Irving Medical Center, New York, New York
| | - Robert S. Zilinyi
- Division of Cardiology, Department of Medicine, Columbia University Irving Medical Center, New York, New York
| | - Takehiko Kido
- Division of Cardiology, Department of Medicine, Columbia University Irving Medical Center, New York, New York
| | - Danial Saleem
- Division of Cardiology, Department of Medicine, Columbia University Irving Medical Center, New York, New York
| | - Isaac Dreyfus
- Division of Cardiology, Department of Medicine, University of California Los Angeles, Los Angeles, California
| | - Samuel Bruce
- Department of Medicine, NewYork-Presbyterian/Columbia University Irving Medical Center, New York, New York
| | - Elena Wadden
- Department of Medicine, NewYork-Presbyterian/Columbia University Irving Medical Center, New York, New York
| | - Zachary Girvin
- Department of Medicine, NewYork-Presbyterian/Columbia University Irving Medical Center, New York, New York
| | - Matthew T. Finn
- Division of Cardiology, Department of Medicine, Columbia University Irving Medical Center, New York, New York
| | - Ajay J. Kirtane
- Division of Cardiology, Department of Medicine, Columbia University Irving Medical Center, New York, New York
| | - Akiko Maehara
- Division of Cardiology, Department of Medicine, Columbia University Irving Medical Center, New York, New York
| | - Sanjum S. Sethi
- Division of Cardiology, Department of Medicine, Columbia University Irving Medical Center, New York, New York
| | - Sahil A. Parikh
- Division of Cardiology, Department of Medicine, Columbia University Irving Medical Center, New York, New York
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Blessing E. [AVK III: Below the knee]. INNERE MEDIZIN (HEIDELBERG, GERMANY) 2025; 66:268-273. [PMID: 40019531 DOI: 10.1007/s00108-025-01871-y] [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: 02/06/2025] [Indexed: 03/01/2025]
Abstract
There has been great progress in the field of endovascular therapy in recent years, particularly in the femoropopliteal vascular segment. Of particular importance here is lesion preparation, which has led to a significant reduction in restenosis and thus revascularisation rates. The use of mostly paclitaxel-based drug-coated balloons or stents has shown clear advantages over conventional balloon dilatation (POBA). This article will present and describe the various balloon and stent systems that can be used in endovascular therapy below the knee.
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Affiliation(s)
- Erwin Blessing
- Klinik für Gefäßmedizin, Universitäres Herz- und Gefäßzentrum, Universitätsklinikum Hamburg-Eppendorf, Martinistr. 52, 20246, Hamburg, Deutschland.
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Sun G, Zhang W, Li T, Zhang G, Li H, Gao X, Zhu G, Zhang D, Guo W. Preclinical evaluation of the sirolimus-eluting iron bioresorbable scaffold in canine below-the-knee artery. Int J Cardiol 2025; 420:132722. [PMID: 39537105 DOI: 10.1016/j.ijcard.2024.132722] [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: 08/01/2024] [Revised: 10/16/2024] [Accepted: 11/08/2024] [Indexed: 11/16/2024]
Abstract
BACKGROUND AND AIMS Infrapopliteal artery intervention has yielded suboptimal results in below-the-knee (BTK) arterial disease. However, bioresorbable scaffolds are a potential treatment for this condition. This study compared the support performance, anti-hyperplastic effects, and histological manifestations between a sirolimus-eluting iron bioresorbable scaffold (IBS) and an everolimus-eluting stent (EES) within 6 months and the corrosion profile during 12 months in canine BTK arteries. METHODS Eighteen IBS and twelve EES systems were implanted into nonatherosclerotic BTK arteries in dogs. Support performance and inhibit intimal hyperplasia, histological manifestations, and the corrosion profile were compared between the two systems using angiography, optical coherence tomography (OCT), micro-computed tomography, and histopathologic evaluation at 1, 3, 6, and 12 months. RESULTS All systems were successfully implanted. There was no significant difference in the area of stenosis between the IBS and EES groups within 6 months. Semi-quantitative OCT revealed degradation of the IBS at 3 months, with strut corrosion rates of 24.6 %, 45.0 %, and 69.2 % at 3, 6, and 12 months. Micro-computed tomography showed that the IBS maintained its integrity at 1 month without corrosion, with more struts fractured because of degradation at 6 and 12 months. Endothelialization was complete at 1 month in both groups. There was no significant between-group difference in cell responses during 6 months of follow-up, with the exception of macrophages. CONCLUSION This preclinical study suggests that the IBS has performance support, anti-hyperplastic effects, and histological manifestations comparable to those of the EES within 6 months, with a reasonable corrosion profile over 12 months.
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Affiliation(s)
- Guoyi Sun
- Department of Vascular and Endovascular Surgery, First Medical Center of Chinese PLA General Hospital, Beijing 100853, China
| | - Wanqian Zhang
- National and Local Joint Engineering Laboratory of Interventional Medical Biotechnology and System, Biotyx Medical (Shenzhen) Co., Ltd, Lifetech Scientific (Shenzhen) Co. Ltd., Shenzhen 518110, China; State Key Laboratory of Molecular Engineering of Polymers, Department of Macromolecular Science, Fudan University, Shanghai 200438, China.
| | - Tao Li
- Department of Vascular Surgery, the First Affiliated Hospital of Shenzhen University, Shenzhen Second People's Hospital, Shenzhen 518035, China
| | - Gui Zhang
- National and Local Joint Engineering Laboratory of Interventional Medical Biotechnology and System, Biotyx Medical (Shenzhen) Co., Ltd, Lifetech Scientific (Shenzhen) Co. Ltd., Shenzhen 518110, China.
| | - Haifeng Li
- National and Local Joint Engineering Laboratory of Interventional Medical Biotechnology and System, Biotyx Medical (Shenzhen) Co., Ltd, Lifetech Scientific (Shenzhen) Co. Ltd., Shenzhen 518110, China.
| | - Xian Gao
- National and Local Joint Engineering Laboratory of Interventional Medical Biotechnology and System, Biotyx Medical (Shenzhen) Co., Ltd, Lifetech Scientific (Shenzhen) Co. Ltd., Shenzhen 518110, China.
| | - Guoxian Zhu
- Department of Vascular Surgery, the First Affiliated Hospital of Shenzhen University, Shenzhen Second People's Hospital, Shenzhen 518035, China.
| | - Deyuan Zhang
- National and Local Joint Engineering Laboratory of Interventional Medical Biotechnology and System, Biotyx Medical (Shenzhen) Co., Ltd, Lifetech Scientific (Shenzhen) Co. Ltd., Shenzhen 518110, China.
| | - Wei Guo
- Department of Vascular and Endovascular Surgery, First Medical Center of Chinese PLA General Hospital, Beijing 100853, China.
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Nasel C, Kirschner M, Rizzi K, Schweinhammer N, Moser E. Magnetic resonance angiography in diagnostic long-term follow-up of primary patency of the MOTIV drug-eluting bioresorbable vascular scaffold in the region below the knee: 5 years of experience. PLoS One 2025; 20:e0313696. [PMID: 39854598 PMCID: PMC11761161 DOI: 10.1371/journal.pone.0313696] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/09/2024] [Accepted: 10/30/2024] [Indexed: 01/26/2025] Open
Abstract
PURPOSE Treatment of peripheral artery disease (PAD) in the region below the knee (BTK) is dissatisfying as failure of treated target lesions (TLF) is frequent and diagnostic imaging is often challenging. In the BTK-region metallic drug-eluting stents (mDES) yielded best results concerning primary patency (PP), but also annihilate signal in magnetic resonance angiography (MR-A). A recently introduced non-metallic drug eluting bioresorbable Tyrocore® vascular scaffold (deBVS), that offers an option for re-treatment of lesions due to its full degradation within 3-4 years after placement, was investigated with respect to its compatibility with MR-A to unimpededly depict previously treated target lesions. METHODS Patency of the deBVS in the BTK-region was assessed retrospectively using contrast enhanced MR-A of the lower limbs in patients with PAD of Lafontaine-grades II-IV (n = 19). Clinically driven MR-A censoring was triggered by an assumed target lesion failure (CD-TLF), which served to compute the probability of PP during the observation period of 5 years. Compatibility of this particular deBVS with MRI was additionally proven via in-vitro experiments. RESULTS The scaffold was found to be fully compatible with MRI. The normalised intra-luminal signal measured in MR-A increased significantly after successful deBVS-placement. The retrospective 5-years PP-probability was 0.87 (CI95%: [0.71,1.0]) with 2 stent-occlusions observed after 90 days. No major adverse events occurred. CONCLUSION Assessment of PAD in the BTK-region after placement of the Tyrocore®-deBVS using MRA is feasible. The promising high PP-probability after 5-years and the persistent full interpretability of treated target lesions by MR-A after stent-placement encourage further prospective assessment of this deBVS in treatment of PAD in the BTK-region.
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Affiliation(s)
- Christian Nasel
- Department of Radiology, University Hospital Tulln, Karl Landsteiner University of Health Sciences, Tulln, Austria
- Department of Medical Imaging and Image-guided Therapy, Medical University of Vienna, Vienna, Austria
- Center for Medical Physics and Biomedical Engineering, Medical University of Vienna, Vienna, Austria
| | - Mario Kirschner
- Department of Radiology, University Hospital Tulln, Karl Landsteiner University of Health Sciences, Tulln, Austria
| | - Karoline Rizzi
- Department of Radiology, University Hospital Tulln, Karl Landsteiner University of Health Sciences, Tulln, Austria
| | - Nicola Schweinhammer
- Department of Neurology—University Hospital Tulln, Karl Landsteiner University of Health Sciences, Tulln, Austria
| | - Ewald Moser
- Center for Medical Physics and Biomedical Engineering, Medical University of Vienna, Vienna, Austria
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Leatham SJ, Winckel KR, De Guzman KR. Management and Pharmacological Treatment of Peripheral Arterial Disease. J Pharm Pract 2024; 37:1337-1345. [PMID: 38693597 DOI: 10.1177/08971900241250084] [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: 05/03/2024]
Abstract
Background: Peripheral arterial disease (PAD) is a complex, heterogeneous condition that has become a leading health concern globally. Peripheral arterial disease often co-exists with other vascular disease states, including cerebrovascular and cardiovascular disease. Optimal therapy for managing symptoms and progression of disease employs non-pharmacological, pharmacological, and contemporary revascularisation techniques to improve clinical outcomes and quality of life. However, large well-designed randomised control trials (RCT) and corresponding evidence-based guidelines for management of PAD are lacking, with current practice standards often extrapolated from evidence in coronary artery disease. Purpose: This review article aims to discuss currently accepted best pharmacological practice for PAD. Method: Relevant articles were searched between May 2023 and January 2024 through PubMed, Cochrane Library, Google Scholar and international guidelines, focusing on pharmacological management for PAD. Results: This narrative review discusses holistic pharmacological treatments for PAD.
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Affiliation(s)
- Samantha J Leatham
- Department of Pharmacy, Princess Alexandra Hospital, Brisbane, QLD, Australia
| | - Karl R Winckel
- Department of Pharmacy, Princess Alexandra Hospital, Brisbane, QLD, Australia
- School of Pharmacy, The University of Queensland, Brisbane, QLD, Australia
| | - Keshia R De Guzman
- Department of Pharmacy, Princess Alexandra Hospital, Brisbane, QLD, Australia
- School of Pharmacy, The University of Queensland, Brisbane, QLD, Australia
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Creeden T, Jones DW. "Evolution of Drug-Coated Devices for the Treatment of Chronic Limb Threatening Ischemia". Ann Vasc Surg 2024; 107:76-83. [PMID: 38582201 DOI: 10.1016/j.avsg.2023.11.061] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/15/2023] [Accepted: 11/24/2023] [Indexed: 04/08/2024]
Abstract
For patients with Chronic Limb Threatening Ischemia (CLTI), endovascular approaches to revascularization are often employed as a component of multimodality care aimed at limb preservation. However, patients with CLTI are also prone to treatment failure, particularly following balloon angioplasty alone. Drug-coated devices utilizing Paclitaxel were developed to decrease restenosis but have been primarily studied in patients presenting with claudication. In recent years, data have emerged which describe the efficacy of drug-coated devices in the treatment of patients with CLTI. Concurrently, there has been major controversy surrounding the use of drug-coated devices in peripheral arterial disease. A historical narrative of the development and use of drug-coated devices for peripheral arterial disease is presented, along with discussion of major trials. Evidence argues that paclitaxel-based therapies for peripheral arterial disease (PAD) do not increase mortality risk compared to nondrug-coated devices. In CLTI patients, paclitaxel-based balloons and stents provide superior patency and freedom reintervention compared to nondrug-coated devices when treating femoropopliteal disease. However, the use of Paclitaxel-based therapies for below-the-knee (BTK) interventions has not been shown to provide clinically meaningful outcomes compared to nondrug-based therapies. Newer generation antiproliferative agents (Sirolimus, Everolimus) and delivery systems (bioabsorbable scaffolds) hold promise for BTK interventions with early data suggesting decreased rates of major amputation or major adverse limb events.
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Affiliation(s)
- Thomas Creeden
- Division of Vascular and Endovascular Surgery, University of Massachusetts Medical School, UMass Medical Center, Worcester, MA
| | - Douglas W Jones
- Division of Vascular and Endovascular Surgery, University of Massachusetts Medical School, UMass Medical Center, Worcester, MA.
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Abumoawad A, Okazaki RA, Behrooz L, Eberhardt RT. Medical Optimization of Patients with Symptomatic Peripheral Arterial Disease. Ann Vasc Surg 2024; 107:170-180. [PMID: 38582206 DOI: 10.1016/j.avsg.2024.01.027] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/27/2023] [Accepted: 01/03/2024] [Indexed: 04/08/2024]
Abstract
Peripheral artery disease (PAD) is a progressive disease associated with the occurrence of major adverse cardiovascular and limb events and elevated mortality rates. Symptoms of PAD, including claudication and chronic limb-threatening ischemia, impair functional capacity and lead to lower quality of life. The focus of current therapies is to minimize symptoms, improve quality of life, and reduce adverse cardiovascular and limb events. Among the medical therapies are antiplatelets, anticoagulants, antihypertensives, lipid lowering therapies, cilostazol and pentoxifylline, and novel blood sugar-lowering therapies, plus exercise therapy and smoking cessation. In this review, we discuss these evidence-based medical therapies that are available for patients with symptomatic PAD.
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Affiliation(s)
| | - Ross A Okazaki
- Evans Department of Medicine/Section of Cardiovascular Medicine and Whitaker Cardiovascular Institute, Boston University Chobanian & Avedisian School of Medicine, Boston, MA
| | - Leili Behrooz
- Department of Cardiovascular Medicine, Medical College of Wisconsin, Milwaukee, WI
| | - Robert T Eberhardt
- Evans Department of Medicine/Section of Cardiovascular Medicine and Whitaker Cardiovascular Institute, Boston University Chobanian & Avedisian School of Medicine, Boston, MA.
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Teymen B, Emin Öner M, Erdağ Y. Compensating for Angiographic Underestimation With Oversized Balloon Angioplasty in Patients With Chronic Limb-Threatening Ischemia and Occluded Below-the-Knee Vessels. J Endovasc Ther 2024:15266028241283534. [PMID: 39342445 DOI: 10.1177/15266028241283534] [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: 10/01/2024]
Abstract
PURPOSE Our study aims to determine optimal sizing of below-the-knee (BTK) artery angioplasty without intravascular ultrasound (IVUS), compensating for conventional angiography underestimation by selecting a balloon size one size larger than the 1-to-1 angiographic sizing. MATERIALS AND METHODS Our study is a retrospective, single-center study. Patients were separated into 2 groups as over and angiographic reference group which the over group is larger balloon diameter selection (0.5-mm larger balloon diameter selection), and angiographic reference group is 1-to-1 balloon diameter selection by angiographic images. Primary end point was the target vessel reocclusion, whereas major and minor amputation was the secondary end point. RESULTS Eighty-four patients with occluded BTK lesions treated with balloon angioplasty (Opt=43, Over=41). Primary patency was 62.8% at 12 months in angiographic reference group and 82.9% in over group (p=0.039). Amputation rate at 1-year follow-up was 9.8% in angiographic reference group and 16.3% in over group (p=0.382). TLR rate is 4.9% in over group versus 20.9% in angiographic reference group (20.9%) at 1-year follow-up (p=0.029). CONCLUSION Our study demonstrates that oversizing the balloon diameter by one size larger in BTK artery angioplasty, guided by conventional angiography, results in a higher patency rate and a lower target lesion revascularization (TLR) rate, while amputation rate remains statistically similar between the 2 groups. CLINICAL IMPACT Our study highlights the importance of compensating for conventional angiography's underestimation in BTK artery angioplasty by using a balloon size one size larger than the 1-to-1 angiographic sizing. Our findings demonstrate that oversizing the balloon leads to significantly higher patency rates and lower TLR rates, with no increase in amputation risk. This approach provides a practical, cost-effective solution for clinicians performing angioplasty without IVUS, allowing for better vessel treatment and outcomes in patients with chronic limb-threatening ischemia. Clinicians can implement this strategy to optimize long-term results in BTK interventions.
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Affiliation(s)
- Burak Teymen
- Department of Cardiology, Emsey Hospital, Istanbul, Turkey
| | - Mehmet Emin Öner
- Department of Cardiovascular Surgery, Emsey Hospital, Istanbul, Turkey
| | - Yiğit Erdağ
- Department of Ortopaedics and Traumatology, Medar Hospital, Kocaeli, Turkey
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12
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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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13
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Teymen B, Öner ME, Erdağ Y. Dual-pathway inhibition in patients with chronic limb-threatening ischemia requiring reintervention for infrapopliteal occlusions. Heart Vessels 2024; 39:771-777. [PMID: 38647656 DOI: 10.1007/s00380-024-02406-5] [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: 01/17/2024] [Accepted: 04/03/2024] [Indexed: 04/25/2024]
Abstract
Our study aimed to assess the influence of incorporating new oral anticoagulant (NOAC) therapy on clinical outcomes among patients who underwent endovascular intervention for below-the-knee (BTK) occlusions necessitating reintervention. The inclusion criteria encompassed patients with chronic limb-threatening ischemia (CLTI) and had undergone a successful endovascular intervention for BTK artery occlusion, necessitating reintervention. Patients who underwent endovascular interventions for BTK reocclusion were compared to those who received dual-pathway inhibition with NOAC (rivaroxaban 2.5 mg 2 × 1) and clopidogrel (NOAC group), or dual-antiplatelet therapy with clopidogrel and aspirin (DAPT group). The primary endpoints were target vessel reocclusion and target lesion revascularization (TLR) at the 1-year follow-up, while major and minor amputations served as the secondary endpoint. Additionally, a one-year comparison was conducted between the two groups for major bleeding events. 64 patients in our clinic treated with endovascular reintervention (NOAC = 28, DAPT = 34). The TLR rate is 10.7% in NOAC group (N = 3) and 32.4% in DAPT group (N = 11, p = 0.043). The target vessel reocclusion rate is 17.8% in NOAC group (N = 5) and 41.2% in DAPT group (N = 14, p = 0.048). Minor or major amputation rate at 1-year follow-up was 3.6% in NOAC group (N = 1) and 11.7% in DAPT group (N = 4, p = 0.245). The patency rate is significantly higher, and the TLR rate is significantly lower in the NOAC group compared to the DAPT group, with no significant difference in major bleeding between the two groups. Although no statistically significant difference exists in amputation rates, a numerical distinction is evident.
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Affiliation(s)
- Burak Teymen
- Department of Cardiology, Emsey Hospital, Kurtköy Pendik, 34912, Istanbul, Turkey.
| | - Mehmet Emin Öner
- Department of Cardiovascular Surgery, Emsey Hospital, Istanbul, Turkey
| | - Yiğit Erdağ
- Department of Orthopaedics and Traumatology, Medar Hospital, Kocaeli, Turkey
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14
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Jain H, Odat RM, Pervez N, Dey D, Singh J, Jain J, Goyal A, Ahmed M, Patel N, Jha J, Passey S. Efficacy and Outcomes of Stenting Versus Balloon Angioplasty for Chronic Limb-Threatening Ischemia in Infrapopliteal Peripheral Arterial Disease: A Meta-Analysis of Randomized Controlled Trials. Cardiol Rev 2024:00045415-990000000-00314. [PMID: 39171926 DOI: 10.1097/crd.0000000000000770] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 08/23/2024]
Abstract
Peripheral arterial disease (PAD) and its severe complication, chronic limb-threatening ischemia (CLTI) are associated with significant morbidity and mortality worldwide. Conventionally, balloon angioplasty has been regarded as superior to stenting in CLTI associated with infrapopliteal PAD. Stenting is often considered a "rescue" or "bail-out" procedure in managing CLTI. However, stenting using newer generation stents coated with antiproliferative drugs such as paclitaxel has demonstrated noninferior results compared with balloon angioplasty in terms of risk of restenosis. However, the current data comparing stenting to balloon angioplasty for other outcomes is rather inconsistent. Major bibliographic databases were searched systematically to identify randomized controlled trials (RCTs) comparing stenting to balloon angioplasty in CLTI in infrapopliteal PAD patients. Risk ratios (RR) with 95% confidence intervals (CI) were pooled in a random-effects model with statistical significance considered at P < 0.05. 9 RCTs with 1125 patients (634, stenting; 491, balloon angioplasty) were included. Stenting was associated with a statistically significant reduction in the risk of binary restenosis (RR, 0.61; 95% CI, 0.38-0.97; P = 0.04] compared with balloon angioplasty. However, no statistically significant difference in technical success, all-cause mortality, clinically driven target lesion revascularization, major limb amputation, and primary patency was observed between the 2 groups. In infrapopliteal PAD associated with CLTI, stenting is noninferior to balloon angioplasty. Future large multicentric RCTs are warranted, particularly evaluating the newer generation drug-eluting stents, in a diverse patient population with longer follow-up periods to corroborate the results of this meta-analysis.
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Affiliation(s)
- Hritvik Jain
- From the Department of Internal Medicine, All India Institute of Medical Sciences (AIIMS), Jodhpur, India
| | - Ramez M Odat
- Department of Internal Medicine, Faculty of Medicine, Jordan University of Science and Technology, Irbid, Jordan
| | - Neha Pervez
- Department of Internal Medicine, Dow University of Health Sciences, Karachi, Pakistan
| | - Debankur Dey
- Department of Internal Medicine, Medical College Kolkata, Kolkata, India
| | - Jagjot Singh
- Department of Internal Medicine, Government Medical College, Amritsar, India
| | - Jyoti Jain
- From the Department of Internal Medicine, All India Institute of Medical Sciences (AIIMS), Jodhpur, India
| | - Aman Goyal
- Department of Internal Medicine, Seth GS Medical College and KEM Hospital, Mumbai, India
| | - Mushood Ahmed
- Department of Internal Medicine, Rawalpindi Medical University, Rawalpindi, Pakistan
| | - Nandan Patel
- From the Department of Internal Medicine, All India Institute of Medical Sciences (AIIMS), Jodhpur, India
| | - Jagriti Jha
- Department of Pediatrics, University of Connecticut Health Center, CT, and
| | - Siddhant Passey
- Department of Internal Medicine, University of Connecticut Health Center, CT
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15
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Guetl K, Muster V, Schweiger L, Tang WC, Patel K, Brodmann M. Standard Balloon Angioplasty Versus Serranator Serration Balloon Angioplasty for the Treatment of Below-the-Knee Artery Occlusive Disease: A Single-Center Subanalysis From the PRELUDE-BTK Prospective Study. J Endovasc Ther 2024; 31:615-621. [PMID: 36408609 DOI: 10.1177/15266028221134891] [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: 02/17/2024]
Abstract
BACKGROUND Endovascular interventions in infrapopliteal occlusive artery disease are becoming more complex, and this frequently tests the standard method of treatment, plain old balloon angioplasty (POBA). The potential that serration angioplasty could produce a more acceptable tibial artery lumen was assessed in this study. AIM The aim of this single-center subgroup analysis was to compare acute angiographic results after endovascular treatment using the Serranator serration balloon catheter in patients participating in the PRELUDE-BTK trial with POBA of the infrapopliteal arteries. A secondary objective was to assess post-treatment hemodynamic improvements. METHODS Our center enrolled 15 subjects and treated 17 lesions within the multicenter prospective core laboratory-adjudicated PRELUDE-BTK study. A 25 lesions analyzed separately were treated with POBA and then compared with the Serranator subset. In both cohorts, lesions were treated with either plain angioplasty or Serranator as a stand-alone therapy; subsequent methods, such as drug elution technologies, were not used. Acute angiographic results were analyzed by the SynvaCor angiographic core laboratory. To assess volumetric flow rates, data were analyzed with a fluid flow simulation software and compared against Poiseuille's Law. RESULTS Final residual stenosis was 17.2%±8.2% in the Serranator group versus 33.7%±15.7% in the POBA group. The mean lumen diameter (MLD) gain for the Serranator group and the POBA group was 1.64±0.41 mm and 1.33±0.63 mm, respectively. The average atmospheric balloon inflation pressure was 5 ATM in the Serranator group versus 9 ATM in the POBA group. Neither group required a bailout stent; however, it was notable that there were significantly more chronic total occlusions (CTOs) treated in the Serranator group at 41.2% versus 12% in the POBA group. Regarding the effectiveness in improving hemodynamic blood flow for non-CTO lesions, the calculated average ratio of post-treatment to pre-treatment flow rates in the Serranator group was 238% than that for the POBA group. For CTO cases where pre-treatment flow rate was zero, final residual stenosis was used as the parameter for comparison. The Serranator group showed a 62% improvement in final residual stenosis over POBA. CONCLUSION Endovascular treatment of the infrapopliteal arteries by use of the Serranator serration balloon provides a novel and promising method of action compared with standard balloon angioplasty and, thus, may have a leading role in complex below-the-knee arterial lesions. CLINICAL IMPACT The Serranator device might help to adequately address issues with conventional routine techniques for the treatment of complex lesions in infrapopliteal arteries in patients with advanced stages of PAD and critical limb ischemia. Integrating modern technologies such as the Serranator balloon catheter into clinical routine is mandatory in order to gain a more favorable outcome in these severely diseased patients and, particularly, to reduce mortality and morbidity.
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Affiliation(s)
- Katharina Guetl
- Division of Angiology, Department of Internal Medicine, Medical University of Graz, Graz, Austria
| | - Viktoria Muster
- Division of Angiology, Department of Internal Medicine, Medical University of Graz, Graz, Austria
| | - Leyla Schweiger
- Division of Angiology, Department of Internal Medicine, Medical University of Graz, Graz, Austria
| | - William C Tang
- Department of Biomedical Engineering, University of California, Irvine, Irvine, CA, USA
| | - Kaushal Patel
- Department of Mechanical Engineering, University of California, Irvine, Irvine, CA, USA
| | - Marianne Brodmann
- Division of Angiology, Department of Internal Medicine, Medical University of Graz, Graz, Austria
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16
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Lim E, Varcoe RL. Current Status of and Future Prospects for Drug-Eluting Stents and Scaffolds in Infrapopliteal Arteries. J Clin Med 2024; 13:1757. [PMID: 38541981 PMCID: PMC10970957 DOI: 10.3390/jcm13061757] [Citation(s) in RCA: 1] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/07/2024] [Revised: 03/03/2024] [Accepted: 03/12/2024] [Indexed: 11/11/2024] Open
Abstract
Background: Chronic limb-threatening ischaemia can be a debilitating disease and may result in limb amputation if untreated. Atherosclerotic disease of the infra-popliteal arteries is particularly challenging to treat due to the small caliber of the vessels and the heavy burden of atherosclerotic plaque. Percutaneous transluminal angioplasty is the conventional first-line approach and is advantageous due to its minimal invasiveness, repeatability, and cost-effectiveness but is limited by high rates of elastic recoil, dissection, and short- to mid-term re-stenosis. Methods: This review analyses the growing body of published and presented clinical data from multiple randomised controlled trials that have investigated the role of coronary drug-eluting stents in the treatment of infrapopliteal disease. Results: Coronary drug-eluting stents demonstrate superior primary patency compared with angioplasty and/or bare metal stenting alone but are limited to application in short-segment disease and have not been widely adopted due to the nature of the permanent implant. Conclusions: Newer devices like drug-eluting resorbable scaffolds are promising as they allow the restoration of vessel wall vasomotion without a residual foreign body and can be used to treat longer, complex lesions.
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Affiliation(s)
- Elizabeth Lim
- The Prince of Wales Hospital, Sydney, NSW 2031, Australia;
| | - Ramon L. Varcoe
- The Prince of Wales Hospital, University of New South Wales, Sydney, NSW 2031, Australia
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17
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Zilinyi RS, Alsaloum M, Snyder DJ, Raja A, Mintz AJ, Sethi SS, Bajakian D, Parikh SA. Surgical and Endovascular Therapies for Below-the-Knee Peripheral Arterial Disease: A Contemporary Review. JOURNAL OF THE SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY & INTERVENTIONS 2024; 3:101268. [PMID: 39131787 PMCID: PMC11308828 DOI: 10.1016/j.jscai.2023.101268] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 04/07/2023] [Revised: 11/28/2023] [Accepted: 12/14/2023] [Indexed: 08/13/2024]
Abstract
Peripheral arterial disease (PAD) represents one of the most prevalent cardiovascular disease processes and carries a high burden of morbidity and mortality. Patients with chronic limb-threatening ischemia (CLTI), the most severe manifestation of PAD, have the highest rates of cardiovascular morbidity and mortality of the overall PAD population. Patients with below-the-knee (BTK) PAD have an increased propensity toward CLTI due to small-vessel caliber and the frequently comorbid conditions of end-stage renal disease and diabetes mellitus, which tend to affect small artery beds preferentially. For those with BTK PAD with CLTI, the standard of care is revascularization. Early revascularization was performed using surgical bypass. However, endovascular techniques, starting with percutaneous transluminal angioplasty and expanding to the modern armamentarium of adjunctive devices and therapies, have become standard of care for most patients with CLTI due to BTK PAD. In this review, we will discuss the modern surgical and endovascular approaches to revascularization, as well as devices that are currently in development or preapproval study for the treatment of BTK PAD.
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Affiliation(s)
- Robert S. Zilinyi
- Division of Cardiology, Department of Medicine, NewYork-Presbyterian/Columbia University Irving Medical Center, New York, New York
| | - Marissa Alsaloum
- Department of Medicine, NewYork-Presbyterian Hospital/Columbia University Irving Medical Center, New York, New York
| | - Daniel J. Snyder
- Department of Medicine, NewYork-Presbyterian Hospital/Columbia University Irving Medical Center, New York, New York
| | - Aishwarya Raja
- Department of Medicine, NewYork-Presbyterian Hospital/Columbia University Irving Medical Center, New York, New York
| | - Ari J. Mintz
- Division of Cardiology, Department of Medicine, NewYork-Presbyterian/Columbia University Irving Medical Center, New York, New York
| | - Sanjum S. Sethi
- Division of Cardiology, Department of Medicine, NewYork-Presbyterian/Columbia University Irving Medical Center, New York, New York
| | - Danielle Bajakian
- Division of Vascular Surgery, Department of Surgery, NewYork-Presbyterian/Columbia University Irving Medical Center, New York, New York
| | - Sahil A. Parikh
- Division of Cardiology, Department of Medicine, NewYork-Presbyterian/Columbia University Irving Medical Center, New York, New York
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18
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Cui HJ, Wu YF. The Efficacy of Drug-Coated Balloons and Drug-Eluting Stents in Infrapopliteal Revascularization: A Meta-analysis. J Endovasc Ther 2024:15266028231222385. [PMID: 38183240 DOI: 10.1177/15266028231222385] [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: 01/07/2024]
Abstract
OBJECTIVE The study aimed to compare the effectiveness of drug-coated balloon (DCB) and drug-eluting stents (DESs) to standard endovascular techniques like percutaneous transluminal angioplasty (PTA) and bare metal stent (BMS) for treating infrapopliteal artery disease. METHODS Including 8 DCB trials and 4 DES trials, this meta-analysis of 12 recent randomized controlled trials (RCTs) is comprehensive. We searched MEDLINE, EMBASE, Science of Web, Cochrane, and PubMed for this meta-analysis. We searched these databases for papers from their inception to February 2023. We also analyzed the references given in the listed studies and any future study that cited them. No language or publication date restrictions were applied to the 12 RCTs. The experimental group includes 8 DCB studies and 4 DES investigations, the DCB group is primarily concerned with the paclitaxel devices, whereas the DES group is preoccupied with the "-limus" devices. Key clinical outcomes in this study were primary patency and binary restenosis rates. This study's secondary outcomes are late lumen loss (LLL), clinically-driven target lesion revascularization (CD-TLR), limb amputation, and all-cause mortality. The evidence quality was assessed using Cochrane risk-of-bias. The PROSPERO registration number for this study is CRD42023462038. FINDINGS Only 108 of 1152 publications found satisfied qualifying criteria and contained data. All 13 RCTs have low to moderate bias. Drug-coated balloons and DESs were compared in the excluded study. The analysis comprised 2055 participants from 12 RCTs that met the inclusion criteria, including 1417 DCB patients and 638 DES patients. Drug-coated balloons outperform traditional methods in short-term monitoring of primary patency, binary restenosis, and CD-TLR. The benefits fade over time, and the 2 techniques had similar major amputation rates, mortality rates, and LLL. Drug-eluting stents outperform conventional procedures in primary patency, binary restenosis, and CD-TLR during medium-term to short-term follow-up. Comparing the 2 methods, major and minor amputations, death rate, and LLL were similar. CONCLUSION Comparison of DES and DCB with PTA or BMS shows that DES had better follow-up results. DCB has positive short-term results, but long-term effects differ, however, more research is needed to determine when DES and DCB should be used in medical procedures. CLINICAL IMPACT The provision of additional evidence to substantiate the advancement of drug-coated balloon (DCB) therapy in the treatment of lower limb arteriosclerosis obliterans, particularly in the below-the-knee area characterized by high calcium load and significant occlusion, is comparable in efficacy to conventional procedures. This finding is advantageous for the progress of interventional revascularization. The advancement and efficacy of DCB have resulted in improved treatment outcomes for medical practitioners in clinical settings. Our research incorporates the most recent randomized experiments.
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Affiliation(s)
- Hong-Jie Cui
- Department of Vascular Surgery, Xuanwu Hospital, Capital Medical University, Beijing, China
| | - Ying-Feng Wu
- Department of Vascular Surgery, Luhe Hospital, Capital Medical University, Beijing, China
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19
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Varcoe RL, DeRubertis BG, Kolluri R, Krishnan P, Metzger DC, Bonaca MP, Shishehbor MH, Holden AH, Bajakian DR, Garcia LA, Kum SWC, Rundback J, Armstrong E, Lee JK, Khatib Y, Weinberg I, Garcia-Garcia HM, Ruster K, Teraphongphom NT, Zheng Y, Wang J, Jones-McMeans JM, Parikh SA. Drug-Eluting Resorbable Scaffold versus Angioplasty for Infrapopliteal Artery Disease. N Engl J Med 2024; 390:9-19. [PMID: 37888915 DOI: 10.1056/nejmoa2305637] [Citation(s) in RCA: 39] [Impact Index Per Article: 39.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 10/28/2023]
Abstract
BACKGROUND Among patients with chronic limb-threatening ischemia (CLTI) and infrapopliteal artery disease, angioplasty has been associated with frequent reintervention and adverse limb outcomes from restenosis. The effect of the use of drug-eluting resorbable scaffolds on these outcomes remains unknown. METHODS In this multicenter, randomized, controlled trial, 261 patients with CLTI and infrapopliteal artery disease were randomly assigned in a 2:1 ratio to receive treatment with an everolimus-eluting resorbable scaffold or angioplasty. The primary efficacy end point was freedom from the following events at 1 year: amputation above the ankle of the target limb, occlusion of the target vessel, clinically driven revascularization of the target lesion, and binary restenosis of the target lesion. The primary safety end point was freedom from major adverse limb events at 6 months and from perioperative death. RESULTS The primary efficacy end point was observed (i.e., no events occurred) in 135 of 173 patients in the scaffold group and 48 of 88 patients in the angioplasty group (Kaplan-Meier estimate, 74% vs. 44%; absolute difference, 30 percentage points; 95% confidence interval [CI], 15 to 46; one-sided P<0.001 for superiority). The primary safety end point was observed in 165 of 170 patients in the scaffold group and 90 of 90 patients in the angioplasty group (absolute difference, -3 percentage points; 95% CI, -6 to 0; one-sided P<0.001 for noninferiority). Serious adverse events related to the index procedure occurred in 2% of the patients in the scaffold group and 3% of those in the angioplasty group. CONCLUSIONS Among patients with CLTI due to infrapopliteal artery disease, the use of an everolimus-eluting resorbable scaffold was superior to angioplasty with respect to the primary efficacy end point. (Funded by Abbott; LIFE-BTK ClinicalTrials.gov number, NCT04227899.).
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Affiliation(s)
- Ramon L Varcoe
- From the Prince of Wales Hospital and University of New South Wales, Randwick, Australia (R.L.V.); New York Presbyterian-Weill Cornell Medical Center (B.G.D.), Mount Sinai Hospital (P.K.), and Columbia University Irving Medical Center and Columbia Vagelos College of Physicians and Surgeons (D.R.B., S.A.P.), New York, and Catholic Health Services, St. Francis Hospital and Heart Center, Roslyn (L.A.G.) - all in New York; Syntropic Core Lab and OhioHealth Heart and Vascular, Columbus (R.K.), and University Hospitals Harrington Heart and Vascular Institute, Cleveland (M.H.S.) - both in Ohio; Ballad Health, Kingsport, TN (D.C.M.); CPC Clinical Research, Cardiovascular Division, University of Colorado School of Medicine, Aurora (M.P.B.), and Advanced Heart and Vein Center, Denver (E.A.) - both in Colorado; Auckland Hospital and Auckland University, Grafton, Auckland, New Zealand (A.H.H.); the Department of Surgery, Changi General Hospital, Singapore (S.W.C.K.); Advanced Interventional and Vascular Services, Teaneck, NJ (J.R.); National Taiwan University Hospital, Taipei City, Taiwan (J.-K.L.); First Coast Cardiovascular Institute, Jacksonville, FL (Y.K.); VasCore, Boston (I.W.); MedStar Washington Hospital Center, Washington, DC (H.M.G.-G.); and Abbott Vascular, Santa Clara, CA (K.R., N.T.T., Y.Z., J.W., J.M.J.-M.)
| | - Brian G DeRubertis
- From the Prince of Wales Hospital and University of New South Wales, Randwick, Australia (R.L.V.); New York Presbyterian-Weill Cornell Medical Center (B.G.D.), Mount Sinai Hospital (P.K.), and Columbia University Irving Medical Center and Columbia Vagelos College of Physicians and Surgeons (D.R.B., S.A.P.), New York, and Catholic Health Services, St. Francis Hospital and Heart Center, Roslyn (L.A.G.) - all in New York; Syntropic Core Lab and OhioHealth Heart and Vascular, Columbus (R.K.), and University Hospitals Harrington Heart and Vascular Institute, Cleveland (M.H.S.) - both in Ohio; Ballad Health, Kingsport, TN (D.C.M.); CPC Clinical Research, Cardiovascular Division, University of Colorado School of Medicine, Aurora (M.P.B.), and Advanced Heart and Vein Center, Denver (E.A.) - both in Colorado; Auckland Hospital and Auckland University, Grafton, Auckland, New Zealand (A.H.H.); the Department of Surgery, Changi General Hospital, Singapore (S.W.C.K.); Advanced Interventional and Vascular Services, Teaneck, NJ (J.R.); National Taiwan University Hospital, Taipei City, Taiwan (J.-K.L.); First Coast Cardiovascular Institute, Jacksonville, FL (Y.K.); VasCore, Boston (I.W.); MedStar Washington Hospital Center, Washington, DC (H.M.G.-G.); and Abbott Vascular, Santa Clara, CA (K.R., N.T.T., Y.Z., J.W., J.M.J.-M.)
| | - Raghu Kolluri
- From the Prince of Wales Hospital and University of New South Wales, Randwick, Australia (R.L.V.); New York Presbyterian-Weill Cornell Medical Center (B.G.D.), Mount Sinai Hospital (P.K.), and Columbia University Irving Medical Center and Columbia Vagelos College of Physicians and Surgeons (D.R.B., S.A.P.), New York, and Catholic Health Services, St. Francis Hospital and Heart Center, Roslyn (L.A.G.) - all in New York; Syntropic Core Lab and OhioHealth Heart and Vascular, Columbus (R.K.), and University Hospitals Harrington Heart and Vascular Institute, Cleveland (M.H.S.) - both in Ohio; Ballad Health, Kingsport, TN (D.C.M.); CPC Clinical Research, Cardiovascular Division, University of Colorado School of Medicine, Aurora (M.P.B.), and Advanced Heart and Vein Center, Denver (E.A.) - both in Colorado; Auckland Hospital and Auckland University, Grafton, Auckland, New Zealand (A.H.H.); the Department of Surgery, Changi General Hospital, Singapore (S.W.C.K.); Advanced Interventional and Vascular Services, Teaneck, NJ (J.R.); National Taiwan University Hospital, Taipei City, Taiwan (J.-K.L.); First Coast Cardiovascular Institute, Jacksonville, FL (Y.K.); VasCore, Boston (I.W.); MedStar Washington Hospital Center, Washington, DC (H.M.G.-G.); and Abbott Vascular, Santa Clara, CA (K.R., N.T.T., Y.Z., J.W., J.M.J.-M.)
| | - Prakash Krishnan
- From the Prince of Wales Hospital and University of New South Wales, Randwick, Australia (R.L.V.); New York Presbyterian-Weill Cornell Medical Center (B.G.D.), Mount Sinai Hospital (P.K.), and Columbia University Irving Medical Center and Columbia Vagelos College of Physicians and Surgeons (D.R.B., S.A.P.), New York, and Catholic Health Services, St. Francis Hospital and Heart Center, Roslyn (L.A.G.) - all in New York; Syntropic Core Lab and OhioHealth Heart and Vascular, Columbus (R.K.), and University Hospitals Harrington Heart and Vascular Institute, Cleveland (M.H.S.) - both in Ohio; Ballad Health, Kingsport, TN (D.C.M.); CPC Clinical Research, Cardiovascular Division, University of Colorado School of Medicine, Aurora (M.P.B.), and Advanced Heart and Vein Center, Denver (E.A.) - both in Colorado; Auckland Hospital and Auckland University, Grafton, Auckland, New Zealand (A.H.H.); the Department of Surgery, Changi General Hospital, Singapore (S.W.C.K.); Advanced Interventional and Vascular Services, Teaneck, NJ (J.R.); National Taiwan University Hospital, Taipei City, Taiwan (J.-K.L.); First Coast Cardiovascular Institute, Jacksonville, FL (Y.K.); VasCore, Boston (I.W.); MedStar Washington Hospital Center, Washington, DC (H.M.G.-G.); and Abbott Vascular, Santa Clara, CA (K.R., N.T.T., Y.Z., J.W., J.M.J.-M.)
| | - David C Metzger
- From the Prince of Wales Hospital and University of New South Wales, Randwick, Australia (R.L.V.); New York Presbyterian-Weill Cornell Medical Center (B.G.D.), Mount Sinai Hospital (P.K.), and Columbia University Irving Medical Center and Columbia Vagelos College of Physicians and Surgeons (D.R.B., S.A.P.), New York, and Catholic Health Services, St. Francis Hospital and Heart Center, Roslyn (L.A.G.) - all in New York; Syntropic Core Lab and OhioHealth Heart and Vascular, Columbus (R.K.), and University Hospitals Harrington Heart and Vascular Institute, Cleveland (M.H.S.) - both in Ohio; Ballad Health, Kingsport, TN (D.C.M.); CPC Clinical Research, Cardiovascular Division, University of Colorado School of Medicine, Aurora (M.P.B.), and Advanced Heart and Vein Center, Denver (E.A.) - both in Colorado; Auckland Hospital and Auckland University, Grafton, Auckland, New Zealand (A.H.H.); the Department of Surgery, Changi General Hospital, Singapore (S.W.C.K.); Advanced Interventional and Vascular Services, Teaneck, NJ (J.R.); National Taiwan University Hospital, Taipei City, Taiwan (J.-K.L.); First Coast Cardiovascular Institute, Jacksonville, FL (Y.K.); VasCore, Boston (I.W.); MedStar Washington Hospital Center, Washington, DC (H.M.G.-G.); and Abbott Vascular, Santa Clara, CA (K.R., N.T.T., Y.Z., J.W., J.M.J.-M.)
| | - Marc P Bonaca
- From the Prince of Wales Hospital and University of New South Wales, Randwick, Australia (R.L.V.); New York Presbyterian-Weill Cornell Medical Center (B.G.D.), Mount Sinai Hospital (P.K.), and Columbia University Irving Medical Center and Columbia Vagelos College of Physicians and Surgeons (D.R.B., S.A.P.), New York, and Catholic Health Services, St. Francis Hospital and Heart Center, Roslyn (L.A.G.) - all in New York; Syntropic Core Lab and OhioHealth Heart and Vascular, Columbus (R.K.), and University Hospitals Harrington Heart and Vascular Institute, Cleveland (M.H.S.) - both in Ohio; Ballad Health, Kingsport, TN (D.C.M.); CPC Clinical Research, Cardiovascular Division, University of Colorado School of Medicine, Aurora (M.P.B.), and Advanced Heart and Vein Center, Denver (E.A.) - both in Colorado; Auckland Hospital and Auckland University, Grafton, Auckland, New Zealand (A.H.H.); the Department of Surgery, Changi General Hospital, Singapore (S.W.C.K.); Advanced Interventional and Vascular Services, Teaneck, NJ (J.R.); National Taiwan University Hospital, Taipei City, Taiwan (J.-K.L.); First Coast Cardiovascular Institute, Jacksonville, FL (Y.K.); VasCore, Boston (I.W.); MedStar Washington Hospital Center, Washington, DC (H.M.G.-G.); and Abbott Vascular, Santa Clara, CA (K.R., N.T.T., Y.Z., J.W., J.M.J.-M.)
| | - Mehdi H Shishehbor
- From the Prince of Wales Hospital and University of New South Wales, Randwick, Australia (R.L.V.); New York Presbyterian-Weill Cornell Medical Center (B.G.D.), Mount Sinai Hospital (P.K.), and Columbia University Irving Medical Center and Columbia Vagelos College of Physicians and Surgeons (D.R.B., S.A.P.), New York, and Catholic Health Services, St. Francis Hospital and Heart Center, Roslyn (L.A.G.) - all in New York; Syntropic Core Lab and OhioHealth Heart and Vascular, Columbus (R.K.), and University Hospitals Harrington Heart and Vascular Institute, Cleveland (M.H.S.) - both in Ohio; Ballad Health, Kingsport, TN (D.C.M.); CPC Clinical Research, Cardiovascular Division, University of Colorado School of Medicine, Aurora (M.P.B.), and Advanced Heart and Vein Center, Denver (E.A.) - both in Colorado; Auckland Hospital and Auckland University, Grafton, Auckland, New Zealand (A.H.H.); the Department of Surgery, Changi General Hospital, Singapore (S.W.C.K.); Advanced Interventional and Vascular Services, Teaneck, NJ (J.R.); National Taiwan University Hospital, Taipei City, Taiwan (J.-K.L.); First Coast Cardiovascular Institute, Jacksonville, FL (Y.K.); VasCore, Boston (I.W.); MedStar Washington Hospital Center, Washington, DC (H.M.G.-G.); and Abbott Vascular, Santa Clara, CA (K.R., N.T.T., Y.Z., J.W., J.M.J.-M.)
| | - Andrew H Holden
- From the Prince of Wales Hospital and University of New South Wales, Randwick, Australia (R.L.V.); New York Presbyterian-Weill Cornell Medical Center (B.G.D.), Mount Sinai Hospital (P.K.), and Columbia University Irving Medical Center and Columbia Vagelos College of Physicians and Surgeons (D.R.B., S.A.P.), New York, and Catholic Health Services, St. Francis Hospital and Heart Center, Roslyn (L.A.G.) - all in New York; Syntropic Core Lab and OhioHealth Heart and Vascular, Columbus (R.K.), and University Hospitals Harrington Heart and Vascular Institute, Cleveland (M.H.S.) - both in Ohio; Ballad Health, Kingsport, TN (D.C.M.); CPC Clinical Research, Cardiovascular Division, University of Colorado School of Medicine, Aurora (M.P.B.), and Advanced Heart and Vein Center, Denver (E.A.) - both in Colorado; Auckland Hospital and Auckland University, Grafton, Auckland, New Zealand (A.H.H.); the Department of Surgery, Changi General Hospital, Singapore (S.W.C.K.); Advanced Interventional and Vascular Services, Teaneck, NJ (J.R.); National Taiwan University Hospital, Taipei City, Taiwan (J.-K.L.); First Coast Cardiovascular Institute, Jacksonville, FL (Y.K.); VasCore, Boston (I.W.); MedStar Washington Hospital Center, Washington, DC (H.M.G.-G.); and Abbott Vascular, Santa Clara, CA (K.R., N.T.T., Y.Z., J.W., J.M.J.-M.)
| | - Danielle R Bajakian
- From the Prince of Wales Hospital and University of New South Wales, Randwick, Australia (R.L.V.); New York Presbyterian-Weill Cornell Medical Center (B.G.D.), Mount Sinai Hospital (P.K.), and Columbia University Irving Medical Center and Columbia Vagelos College of Physicians and Surgeons (D.R.B., S.A.P.), New York, and Catholic Health Services, St. Francis Hospital and Heart Center, Roslyn (L.A.G.) - all in New York; Syntropic Core Lab and OhioHealth Heart and Vascular, Columbus (R.K.), and University Hospitals Harrington Heart and Vascular Institute, Cleveland (M.H.S.) - both in Ohio; Ballad Health, Kingsport, TN (D.C.M.); CPC Clinical Research, Cardiovascular Division, University of Colorado School of Medicine, Aurora (M.P.B.), and Advanced Heart and Vein Center, Denver (E.A.) - both in Colorado; Auckland Hospital and Auckland University, Grafton, Auckland, New Zealand (A.H.H.); the Department of Surgery, Changi General Hospital, Singapore (S.W.C.K.); Advanced Interventional and Vascular Services, Teaneck, NJ (J.R.); National Taiwan University Hospital, Taipei City, Taiwan (J.-K.L.); First Coast Cardiovascular Institute, Jacksonville, FL (Y.K.); VasCore, Boston (I.W.); MedStar Washington Hospital Center, Washington, DC (H.M.G.-G.); and Abbott Vascular, Santa Clara, CA (K.R., N.T.T., Y.Z., J.W., J.M.J.-M.)
| | - Lawrence A Garcia
- From the Prince of Wales Hospital and University of New South Wales, Randwick, Australia (R.L.V.); New York Presbyterian-Weill Cornell Medical Center (B.G.D.), Mount Sinai Hospital (P.K.), and Columbia University Irving Medical Center and Columbia Vagelos College of Physicians and Surgeons (D.R.B., S.A.P.), New York, and Catholic Health Services, St. Francis Hospital and Heart Center, Roslyn (L.A.G.) - all in New York; Syntropic Core Lab and OhioHealth Heart and Vascular, Columbus (R.K.), and University Hospitals Harrington Heart and Vascular Institute, Cleveland (M.H.S.) - both in Ohio; Ballad Health, Kingsport, TN (D.C.M.); CPC Clinical Research, Cardiovascular Division, University of Colorado School of Medicine, Aurora (M.P.B.), and Advanced Heart and Vein Center, Denver (E.A.) - both in Colorado; Auckland Hospital and Auckland University, Grafton, Auckland, New Zealand (A.H.H.); the Department of Surgery, Changi General Hospital, Singapore (S.W.C.K.); Advanced Interventional and Vascular Services, Teaneck, NJ (J.R.); National Taiwan University Hospital, Taipei City, Taiwan (J.-K.L.); First Coast Cardiovascular Institute, Jacksonville, FL (Y.K.); VasCore, Boston (I.W.); MedStar Washington Hospital Center, Washington, DC (H.M.G.-G.); and Abbott Vascular, Santa Clara, CA (K.R., N.T.T., Y.Z., J.W., J.M.J.-M.)
| | - Steven W C Kum
- From the Prince of Wales Hospital and University of New South Wales, Randwick, Australia (R.L.V.); New York Presbyterian-Weill Cornell Medical Center (B.G.D.), Mount Sinai Hospital (P.K.), and Columbia University Irving Medical Center and Columbia Vagelos College of Physicians and Surgeons (D.R.B., S.A.P.), New York, and Catholic Health Services, St. Francis Hospital and Heart Center, Roslyn (L.A.G.) - all in New York; Syntropic Core Lab and OhioHealth Heart and Vascular, Columbus (R.K.), and University Hospitals Harrington Heart and Vascular Institute, Cleveland (M.H.S.) - both in Ohio; Ballad Health, Kingsport, TN (D.C.M.); CPC Clinical Research, Cardiovascular Division, University of Colorado School of Medicine, Aurora (M.P.B.), and Advanced Heart and Vein Center, Denver (E.A.) - both in Colorado; Auckland Hospital and Auckland University, Grafton, Auckland, New Zealand (A.H.H.); the Department of Surgery, Changi General Hospital, Singapore (S.W.C.K.); Advanced Interventional and Vascular Services, Teaneck, NJ (J.R.); National Taiwan University Hospital, Taipei City, Taiwan (J.-K.L.); First Coast Cardiovascular Institute, Jacksonville, FL (Y.K.); VasCore, Boston (I.W.); MedStar Washington Hospital Center, Washington, DC (H.M.G.-G.); and Abbott Vascular, Santa Clara, CA (K.R., N.T.T., Y.Z., J.W., J.M.J.-M.)
| | - John Rundback
- From the Prince of Wales Hospital and University of New South Wales, Randwick, Australia (R.L.V.); New York Presbyterian-Weill Cornell Medical Center (B.G.D.), Mount Sinai Hospital (P.K.), and Columbia University Irving Medical Center and Columbia Vagelos College of Physicians and Surgeons (D.R.B., S.A.P.), New York, and Catholic Health Services, St. Francis Hospital and Heart Center, Roslyn (L.A.G.) - all in New York; Syntropic Core Lab and OhioHealth Heart and Vascular, Columbus (R.K.), and University Hospitals Harrington Heart and Vascular Institute, Cleveland (M.H.S.) - both in Ohio; Ballad Health, Kingsport, TN (D.C.M.); CPC Clinical Research, Cardiovascular Division, University of Colorado School of Medicine, Aurora (M.P.B.), and Advanced Heart and Vein Center, Denver (E.A.) - both in Colorado; Auckland Hospital and Auckland University, Grafton, Auckland, New Zealand (A.H.H.); the Department of Surgery, Changi General Hospital, Singapore (S.W.C.K.); Advanced Interventional and Vascular Services, Teaneck, NJ (J.R.); National Taiwan University Hospital, Taipei City, Taiwan (J.-K.L.); First Coast Cardiovascular Institute, Jacksonville, FL (Y.K.); VasCore, Boston (I.W.); MedStar Washington Hospital Center, Washington, DC (H.M.G.-G.); and Abbott Vascular, Santa Clara, CA (K.R., N.T.T., Y.Z., J.W., J.M.J.-M.)
| | - Ehrin Armstrong
- From the Prince of Wales Hospital and University of New South Wales, Randwick, Australia (R.L.V.); New York Presbyterian-Weill Cornell Medical Center (B.G.D.), Mount Sinai Hospital (P.K.), and Columbia University Irving Medical Center and Columbia Vagelos College of Physicians and Surgeons (D.R.B., S.A.P.), New York, and Catholic Health Services, St. Francis Hospital and Heart Center, Roslyn (L.A.G.) - all in New York; Syntropic Core Lab and OhioHealth Heart and Vascular, Columbus (R.K.), and University Hospitals Harrington Heart and Vascular Institute, Cleveland (M.H.S.) - both in Ohio; Ballad Health, Kingsport, TN (D.C.M.); CPC Clinical Research, Cardiovascular Division, University of Colorado School of Medicine, Aurora (M.P.B.), and Advanced Heart and Vein Center, Denver (E.A.) - both in Colorado; Auckland Hospital and Auckland University, Grafton, Auckland, New Zealand (A.H.H.); the Department of Surgery, Changi General Hospital, Singapore (S.W.C.K.); Advanced Interventional and Vascular Services, Teaneck, NJ (J.R.); National Taiwan University Hospital, Taipei City, Taiwan (J.-K.L.); First Coast Cardiovascular Institute, Jacksonville, FL (Y.K.); VasCore, Boston (I.W.); MedStar Washington Hospital Center, Washington, DC (H.M.G.-G.); and Abbott Vascular, Santa Clara, CA (K.R., N.T.T., Y.Z., J.W., J.M.J.-M.)
| | - Jen-Kuang Lee
- From the Prince of Wales Hospital and University of New South Wales, Randwick, Australia (R.L.V.); New York Presbyterian-Weill Cornell Medical Center (B.G.D.), Mount Sinai Hospital (P.K.), and Columbia University Irving Medical Center and Columbia Vagelos College of Physicians and Surgeons (D.R.B., S.A.P.), New York, and Catholic Health Services, St. Francis Hospital and Heart Center, Roslyn (L.A.G.) - all in New York; Syntropic Core Lab and OhioHealth Heart and Vascular, Columbus (R.K.), and University Hospitals Harrington Heart and Vascular Institute, Cleveland (M.H.S.) - both in Ohio; Ballad Health, Kingsport, TN (D.C.M.); CPC Clinical Research, Cardiovascular Division, University of Colorado School of Medicine, Aurora (M.P.B.), and Advanced Heart and Vein Center, Denver (E.A.) - both in Colorado; Auckland Hospital and Auckland University, Grafton, Auckland, New Zealand (A.H.H.); the Department of Surgery, Changi General Hospital, Singapore (S.W.C.K.); Advanced Interventional and Vascular Services, Teaneck, NJ (J.R.); National Taiwan University Hospital, Taipei City, Taiwan (J.-K.L.); First Coast Cardiovascular Institute, Jacksonville, FL (Y.K.); VasCore, Boston (I.W.); MedStar Washington Hospital Center, Washington, DC (H.M.G.-G.); and Abbott Vascular, Santa Clara, CA (K.R., N.T.T., Y.Z., J.W., J.M.J.-M.)
| | - Yazan Khatib
- From the Prince of Wales Hospital and University of New South Wales, Randwick, Australia (R.L.V.); New York Presbyterian-Weill Cornell Medical Center (B.G.D.), Mount Sinai Hospital (P.K.), and Columbia University Irving Medical Center and Columbia Vagelos College of Physicians and Surgeons (D.R.B., S.A.P.), New York, and Catholic Health Services, St. Francis Hospital and Heart Center, Roslyn (L.A.G.) - all in New York; Syntropic Core Lab and OhioHealth Heart and Vascular, Columbus (R.K.), and University Hospitals Harrington Heart and Vascular Institute, Cleveland (M.H.S.) - both in Ohio; Ballad Health, Kingsport, TN (D.C.M.); CPC Clinical Research, Cardiovascular Division, University of Colorado School of Medicine, Aurora (M.P.B.), and Advanced Heart and Vein Center, Denver (E.A.) - both in Colorado; Auckland Hospital and Auckland University, Grafton, Auckland, New Zealand (A.H.H.); the Department of Surgery, Changi General Hospital, Singapore (S.W.C.K.); Advanced Interventional and Vascular Services, Teaneck, NJ (J.R.); National Taiwan University Hospital, Taipei City, Taiwan (J.-K.L.); First Coast Cardiovascular Institute, Jacksonville, FL (Y.K.); VasCore, Boston (I.W.); MedStar Washington Hospital Center, Washington, DC (H.M.G.-G.); and Abbott Vascular, Santa Clara, CA (K.R., N.T.T., Y.Z., J.W., J.M.J.-M.)
| | - Ido Weinberg
- From the Prince of Wales Hospital and University of New South Wales, Randwick, Australia (R.L.V.); New York Presbyterian-Weill Cornell Medical Center (B.G.D.), Mount Sinai Hospital (P.K.), and Columbia University Irving Medical Center and Columbia Vagelos College of Physicians and Surgeons (D.R.B., S.A.P.), New York, and Catholic Health Services, St. Francis Hospital and Heart Center, Roslyn (L.A.G.) - all in New York; Syntropic Core Lab and OhioHealth Heart and Vascular, Columbus (R.K.), and University Hospitals Harrington Heart and Vascular Institute, Cleveland (M.H.S.) - both in Ohio; Ballad Health, Kingsport, TN (D.C.M.); CPC Clinical Research, Cardiovascular Division, University of Colorado School of Medicine, Aurora (M.P.B.), and Advanced Heart and Vein Center, Denver (E.A.) - both in Colorado; Auckland Hospital and Auckland University, Grafton, Auckland, New Zealand (A.H.H.); the Department of Surgery, Changi General Hospital, Singapore (S.W.C.K.); Advanced Interventional and Vascular Services, Teaneck, NJ (J.R.); National Taiwan University Hospital, Taipei City, Taiwan (J.-K.L.); First Coast Cardiovascular Institute, Jacksonville, FL (Y.K.); VasCore, Boston (I.W.); MedStar Washington Hospital Center, Washington, DC (H.M.G.-G.); and Abbott Vascular, Santa Clara, CA (K.R., N.T.T., Y.Z., J.W., J.M.J.-M.)
| | - Hector M Garcia-Garcia
- From the Prince of Wales Hospital and University of New South Wales, Randwick, Australia (R.L.V.); New York Presbyterian-Weill Cornell Medical Center (B.G.D.), Mount Sinai Hospital (P.K.), and Columbia University Irving Medical Center and Columbia Vagelos College of Physicians and Surgeons (D.R.B., S.A.P.), New York, and Catholic Health Services, St. Francis Hospital and Heart Center, Roslyn (L.A.G.) - all in New York; Syntropic Core Lab and OhioHealth Heart and Vascular, Columbus (R.K.), and University Hospitals Harrington Heart and Vascular Institute, Cleveland (M.H.S.) - both in Ohio; Ballad Health, Kingsport, TN (D.C.M.); CPC Clinical Research, Cardiovascular Division, University of Colorado School of Medicine, Aurora (M.P.B.), and Advanced Heart and Vein Center, Denver (E.A.) - both in Colorado; Auckland Hospital and Auckland University, Grafton, Auckland, New Zealand (A.H.H.); the Department of Surgery, Changi General Hospital, Singapore (S.W.C.K.); Advanced Interventional and Vascular Services, Teaneck, NJ (J.R.); National Taiwan University Hospital, Taipei City, Taiwan (J.-K.L.); First Coast Cardiovascular Institute, Jacksonville, FL (Y.K.); VasCore, Boston (I.W.); MedStar Washington Hospital Center, Washington, DC (H.M.G.-G.); and Abbott Vascular, Santa Clara, CA (K.R., N.T.T., Y.Z., J.W., J.M.J.-M.)
| | - Karine Ruster
- From the Prince of Wales Hospital and University of New South Wales, Randwick, Australia (R.L.V.); New York Presbyterian-Weill Cornell Medical Center (B.G.D.), Mount Sinai Hospital (P.K.), and Columbia University Irving Medical Center and Columbia Vagelos College of Physicians and Surgeons (D.R.B., S.A.P.), New York, and Catholic Health Services, St. Francis Hospital and Heart Center, Roslyn (L.A.G.) - all in New York; Syntropic Core Lab and OhioHealth Heart and Vascular, Columbus (R.K.), and University Hospitals Harrington Heart and Vascular Institute, Cleveland (M.H.S.) - both in Ohio; Ballad Health, Kingsport, TN (D.C.M.); CPC Clinical Research, Cardiovascular Division, University of Colorado School of Medicine, Aurora (M.P.B.), and Advanced Heart and Vein Center, Denver (E.A.) - both in Colorado; Auckland Hospital and Auckland University, Grafton, Auckland, New Zealand (A.H.H.); the Department of Surgery, Changi General Hospital, Singapore (S.W.C.K.); Advanced Interventional and Vascular Services, Teaneck, NJ (J.R.); National Taiwan University Hospital, Taipei City, Taiwan (J.-K.L.); First Coast Cardiovascular Institute, Jacksonville, FL (Y.K.); VasCore, Boston (I.W.); MedStar Washington Hospital Center, Washington, DC (H.M.G.-G.); and Abbott Vascular, Santa Clara, CA (K.R., N.T.T., Y.Z., J.W., J.M.J.-M.)
| | - Nutte T Teraphongphom
- From the Prince of Wales Hospital and University of New South Wales, Randwick, Australia (R.L.V.); New York Presbyterian-Weill Cornell Medical Center (B.G.D.), Mount Sinai Hospital (P.K.), and Columbia University Irving Medical Center and Columbia Vagelos College of Physicians and Surgeons (D.R.B., S.A.P.), New York, and Catholic Health Services, St. Francis Hospital and Heart Center, Roslyn (L.A.G.) - all in New York; Syntropic Core Lab and OhioHealth Heart and Vascular, Columbus (R.K.), and University Hospitals Harrington Heart and Vascular Institute, Cleveland (M.H.S.) - both in Ohio; Ballad Health, Kingsport, TN (D.C.M.); CPC Clinical Research, Cardiovascular Division, University of Colorado School of Medicine, Aurora (M.P.B.), and Advanced Heart and Vein Center, Denver (E.A.) - both in Colorado; Auckland Hospital and Auckland University, Grafton, Auckland, New Zealand (A.H.H.); the Department of Surgery, Changi General Hospital, Singapore (S.W.C.K.); Advanced Interventional and Vascular Services, Teaneck, NJ (J.R.); National Taiwan University Hospital, Taipei City, Taiwan (J.-K.L.); First Coast Cardiovascular Institute, Jacksonville, FL (Y.K.); VasCore, Boston (I.W.); MedStar Washington Hospital Center, Washington, DC (H.M.G.-G.); and Abbott Vascular, Santa Clara, CA (K.R., N.T.T., Y.Z., J.W., J.M.J.-M.)
| | - Yan Zheng
- From the Prince of Wales Hospital and University of New South Wales, Randwick, Australia (R.L.V.); New York Presbyterian-Weill Cornell Medical Center (B.G.D.), Mount Sinai Hospital (P.K.), and Columbia University Irving Medical Center and Columbia Vagelos College of Physicians and Surgeons (D.R.B., S.A.P.), New York, and Catholic Health Services, St. Francis Hospital and Heart Center, Roslyn (L.A.G.) - all in New York; Syntropic Core Lab and OhioHealth Heart and Vascular, Columbus (R.K.), and University Hospitals Harrington Heart and Vascular Institute, Cleveland (M.H.S.) - both in Ohio; Ballad Health, Kingsport, TN (D.C.M.); CPC Clinical Research, Cardiovascular Division, University of Colorado School of Medicine, Aurora (M.P.B.), and Advanced Heart and Vein Center, Denver (E.A.) - both in Colorado; Auckland Hospital and Auckland University, Grafton, Auckland, New Zealand (A.H.H.); the Department of Surgery, Changi General Hospital, Singapore (S.W.C.K.); Advanced Interventional and Vascular Services, Teaneck, NJ (J.R.); National Taiwan University Hospital, Taipei City, Taiwan (J.-K.L.); First Coast Cardiovascular Institute, Jacksonville, FL (Y.K.); VasCore, Boston (I.W.); MedStar Washington Hospital Center, Washington, DC (H.M.G.-G.); and Abbott Vascular, Santa Clara, CA (K.R., N.T.T., Y.Z., J.W., J.M.J.-M.)
| | - Jin Wang
- From the Prince of Wales Hospital and University of New South Wales, Randwick, Australia (R.L.V.); New York Presbyterian-Weill Cornell Medical Center (B.G.D.), Mount Sinai Hospital (P.K.), and Columbia University Irving Medical Center and Columbia Vagelos College of Physicians and Surgeons (D.R.B., S.A.P.), New York, and Catholic Health Services, St. Francis Hospital and Heart Center, Roslyn (L.A.G.) - all in New York; Syntropic Core Lab and OhioHealth Heart and Vascular, Columbus (R.K.), and University Hospitals Harrington Heart and Vascular Institute, Cleveland (M.H.S.) - both in Ohio; Ballad Health, Kingsport, TN (D.C.M.); CPC Clinical Research, Cardiovascular Division, University of Colorado School of Medicine, Aurora (M.P.B.), and Advanced Heart and Vein Center, Denver (E.A.) - both in Colorado; Auckland Hospital and Auckland University, Grafton, Auckland, New Zealand (A.H.H.); the Department of Surgery, Changi General Hospital, Singapore (S.W.C.K.); Advanced Interventional and Vascular Services, Teaneck, NJ (J.R.); National Taiwan University Hospital, Taipei City, Taiwan (J.-K.L.); First Coast Cardiovascular Institute, Jacksonville, FL (Y.K.); VasCore, Boston (I.W.); MedStar Washington Hospital Center, Washington, DC (H.M.G.-G.); and Abbott Vascular, Santa Clara, CA (K.R., N.T.T., Y.Z., J.W., J.M.J.-M.)
| | - Jennifer M Jones-McMeans
- From the Prince of Wales Hospital and University of New South Wales, Randwick, Australia (R.L.V.); New York Presbyterian-Weill Cornell Medical Center (B.G.D.), Mount Sinai Hospital (P.K.), and Columbia University Irving Medical Center and Columbia Vagelos College of Physicians and Surgeons (D.R.B., S.A.P.), New York, and Catholic Health Services, St. Francis Hospital and Heart Center, Roslyn (L.A.G.) - all in New York; Syntropic Core Lab and OhioHealth Heart and Vascular, Columbus (R.K.), and University Hospitals Harrington Heart and Vascular Institute, Cleveland (M.H.S.) - both in Ohio; Ballad Health, Kingsport, TN (D.C.M.); CPC Clinical Research, Cardiovascular Division, University of Colorado School of Medicine, Aurora (M.P.B.), and Advanced Heart and Vein Center, Denver (E.A.) - both in Colorado; Auckland Hospital and Auckland University, Grafton, Auckland, New Zealand (A.H.H.); the Department of Surgery, Changi General Hospital, Singapore (S.W.C.K.); Advanced Interventional and Vascular Services, Teaneck, NJ (J.R.); National Taiwan University Hospital, Taipei City, Taiwan (J.-K.L.); First Coast Cardiovascular Institute, Jacksonville, FL (Y.K.); VasCore, Boston (I.W.); MedStar Washington Hospital Center, Washington, DC (H.M.G.-G.); and Abbott Vascular, Santa Clara, CA (K.R., N.T.T., Y.Z., J.W., J.M.J.-M.)
| | - Sahil A Parikh
- From the Prince of Wales Hospital and University of New South Wales, Randwick, Australia (R.L.V.); New York Presbyterian-Weill Cornell Medical Center (B.G.D.), Mount Sinai Hospital (P.K.), and Columbia University Irving Medical Center and Columbia Vagelos College of Physicians and Surgeons (D.R.B., S.A.P.), New York, and Catholic Health Services, St. Francis Hospital and Heart Center, Roslyn (L.A.G.) - all in New York; Syntropic Core Lab and OhioHealth Heart and Vascular, Columbus (R.K.), and University Hospitals Harrington Heart and Vascular Institute, Cleveland (M.H.S.) - both in Ohio; Ballad Health, Kingsport, TN (D.C.M.); CPC Clinical Research, Cardiovascular Division, University of Colorado School of Medicine, Aurora (M.P.B.), and Advanced Heart and Vein Center, Denver (E.A.) - both in Colorado; Auckland Hospital and Auckland University, Grafton, Auckland, New Zealand (A.H.H.); the Department of Surgery, Changi General Hospital, Singapore (S.W.C.K.); Advanced Interventional and Vascular Services, Teaneck, NJ (J.R.); National Taiwan University Hospital, Taipei City, Taiwan (J.-K.L.); First Coast Cardiovascular Institute, Jacksonville, FL (Y.K.); VasCore, Boston (I.W.); MedStar Washington Hospital Center, Washington, DC (H.M.G.-G.); and Abbott Vascular, Santa Clara, CA (K.R., N.T.T., Y.Z., J.W., J.M.J.-M.)
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Katsanos K. Percutaneous Revascularization of the Tibial Arteries. MASTERING ENDOVASCULAR TECHNIQUES 2024:165-172. [DOI: 10.1007/978-3-031-42735-0_17] [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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Li Y, Shen X, Zhuang H. Comparation of drug-eluting stents and control therapy for the treatment of infrapopliteal artery disease: a Bayesian analysis. Int J Surg 2023; 109:4286-4297. [PMID: 37720942 PMCID: PMC10720840 DOI: 10.1097/js9.0000000000000736] [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: 05/18/2023] [Accepted: 08/21/2023] [Indexed: 09/19/2023]
Abstract
BACKGROUND Critical limb-threatening ischaemia is a life-threatening disease which often combines with infrapopliteal arterial disease. Percutaneous transluminal angioplasty (PTA) is recommended as the first-line treatment for infrapopliteal arterial disease. Drug-eluting stent (DES) is another widely used option; however, its long-term therapeutic effect is controversial. The effectiveness of different DES for infrapopliteal arterial disease needs further exploration. METHODS AND RESULTS The PubMed, EMBASE, Cochrane Library and Clinical trials were systematically searched from inception to 1 February 2023. Literatures were included if the study was original, peer-reviewed, published in English or Chinese, and contained patients diagnosed with simple infrapopliteal arterial disease or with properly treated combined inflow tract lesions before or during the study procedure. A total of 953 patients, 504 in the DES group and 449 in the PTA/bare-metal stenting (BMS) group, from 12 randomised controlled trials were included in the meta-analysis. The results showed that DES is superior to control group for improving clinical patency, reducing the restenosis rate, and reducing the amputation rate at 6 months, 1 year, and 3 years post-treatment [at 3 years, risk ratio (RR): 1.90, 95% CI 1.23-2.93; RR: 0.87, 95% CI 0.79-0.96; RR: 0.60, 95% CI 0.36-1.00, P =0.049]. In addition, subgroup analyses suggested that DES is superior to BMS and PTA in improving clinical patency and reducing target lesion revascularisation and restenosis rates at 6-month and 1-year post-treatment. The network meta-analysis indicated that sirolimus-eluting stent was superior for improving clinical patency (at 1 year, RR: 0.23, 95% CI 0.08-0.60) and reducing the restenosis rate (at 6 months, RR: 31.58, 95% CI 4.41-307.53, at 1 year, RR: 3.80, 95% CI 1.84-8.87) significantly. However, according to the cumulative rank probabilities test, everolimus-eluting stent may have the lowest target lesion revascularisation rates and amputation rates at 1-year post-treatment (the cumulative rank probability was 77% and 49%, respectively). CONCLUSIONS This systematic review and network meta-analysis showed that DES was associated with more clinical efficacy than PTA/BMS significantly. In addition, sirolimus-eluting stent and everolimus-eluting stent may have better clinical benefits.
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Affiliation(s)
| | | | - Hui Zhuang
- Xiamen Cardiovascular Hospital, Xiamen University, Xiamen City, Fujian Province, China
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22
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Koyama Y, Migita S, Shimodai-Yamada S, Suzuki M, Uto K, Okumura Y, Ohura N, Hao H. Pathology of Critical Limb Ischemia; Comparison of Plaque Characteristics Between Anterior and Posterior Tibial Arteries. J Atheroscler Thromb 2023; 30:1893-1904. [PMID: 37331812 DOI: 10.5551/jat.64259] [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: 06/20/2023] Open
Abstract
AIMS Though the number of patients with peripheral arterial disease (PAD) and critical limb ischemia (CLI) is increasing, few histopathological studies of PAD, particularly that involving below-the-knee arteries, has been reported. We analyzed the pathology of anterior tibial artery (ATA) and posterior tibial artery (PTA) specimens obtained from patients who underwent lower extremity amputation due to CLIMethods: Dissected ATAs and PTAs were subjected to ex-vivo soft X-ray radiography, followed by pathological examination using 860 histological sections. This protocol was approved by the Ethics Review Board of Nihon University Itabashi Hospital (RK-190910-01) and Kyorin University Hospital (R02-179). RESULTS The calcified area distribution was significantly larger in PTAs than in ATAs on soft X-ray radiographic images (ATAs, 48.3% ±19.2 versus PTAs, 61.6% ±23.9; p＜0.001). Eccentric plaque with necrotic core and macrophage infiltration were more prominent in ATAs than in PTAs (eccentric plaque: ATAs, 63.7% versus PTAs, 49.1%; p＜0.0001, macrophage: ATAs, 0.29% [0.095 - 1.1%] versus PTAs, 0.12% [0.029 - 0.36%]; p＜0.001), histopathologically. Thromboembolic lesions were more frequently identified in PTAs than in ATAs (ATAs, 11.1% versus PTAs 15.8%; p＜0.05). Moreover, post-balloon injury pathology differed between ATAs and PTAs. CONCLUSIONS Histological features differed strikingly between ATAs and PTAs obtained from CLI patients. Clarifying the pathological features of CLI would contribute to establishing therapeutic strategies for PAD, particularly disease involving below-the knee-arteries.
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Affiliation(s)
- Yutaka Koyama
- Division of Human Pathology, Department of Pathology and Microbiology, Nihon University School of Medicine
- Division of Cardiology, Department of Medicine, Nihon University School of Medicine
| | - Suguru Migita
- Division of Human Pathology, Department of Pathology and Microbiology, Nihon University School of Medicine
- Division of Cardiology, Department of Medicine, Nihon University School of Medicine
| | - Sayaka Shimodai-Yamada
- Division of Human Pathology, Department of Pathology and Microbiology, Nihon University School of Medicine
| | - Mayumi Suzuki
- Division of Human Pathology, Department of Pathology and Microbiology, Nihon University School of Medicine
| | - Kenta Uto
- Division of Human Pathology, Department of Pathology and Microbiology, Nihon University School of Medicine
| | - Yasuo Okumura
- Division of Cardiology, Department of Medicine, Nihon University School of Medicine
| | - Norihiko Ohura
- Department of Plastic and Reconstructive Surgery, Kyorin University School of Medicine
| | - Hiroyuki Hao
- Division of Human Pathology, Department of Pathology and Microbiology, Nihon University School of Medicine
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23
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van Overhagen H, Nakamura M, Geraghty PJ, Rao S, Arroyo M, Soga Y, Iida O, Armstrong E, Nakama T, Fujihara M, Ansari MM, Mathews SJ, Gouëffic Y, Jaff MR, Weinberg I, Pinto DS, Ohura N, Couch K, Mustapha JA. Primary results of the SAVAL randomized trial of a paclitaxel-eluting nitinol stent versus percutaneous transluminal angioplasty in infrapopliteal arteries. Vasc Med 2023; 28:571-580. [PMID: 37844137 PMCID: PMC10693734 DOI: 10.1177/1358863x231199489] [Citation(s) in RCA: 14] [Impact Index Per Article: 7.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/18/2023]
Abstract
BACKGROUND Effective and durable options for infrapopliteal artery revascularization for patients with chronic limb-threatening ischemia (CLTI) are limited. METHODS The SAVAL trial is a prospective, multicenter, randomized trial of patients with CLTI and infrapopliteal artery lesions with total lesion length ⩽ 140 mm, stenosis ⩾ 70%, and Rutherford category 4-5 assigned 2:1 to treatment with the SAVAL self-expandable paclitaxel drug-eluting stent (DES) or percutaneous transluminal angioplasty (PTA) with an uncoated balloon. The primary effectiveness endpoint was primary vessel patency (i.e., core lab-adjudicated duplex ultrasound-based flow at 12 months in the absence of clinically driven target lesion revascularization or surgical bypass of the target lesion). The primary safety endpoint was the 12-month major adverse event (MAE)-free rate; MAEs were defined as a composite of above-ankle index limb amputation, major reintervention, and 30-day mortality. The endpoints were prespecified for superiority (effectiveness) and noninferiority (safety) at a one-sided significance level of 2.5%. RESULTS A total of 201 patients were enrolled and randomly assigned to treatment (N = 130 DES, N = 71 PTA). Target lesion length was 68.1 ± 35.2 mm for the DES group and 68.7 ± 49.2 mm for the PTA group, and 31.0% and 27.6% of patients, respectively, had occlusions. The 12-month primary patency rates were 68.0% for the DES group and 76.0% for the PTA group (Psuperiority = 0.8552). The MAE-free rates were 91.6% and 95.3%, respectively (Pnoninferiority = 0.0433). CONCLUSION The SAVAL trial did not show benefit related to effectiveness and safety with the nitinol DES compared with PTA in infrapopliteal artery lesions up to 140 mm in length. Continued innovation to provide optimal treatments for CLTI is needed. (ClinicalTrials.gov Identifier: NCT03551496).
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Affiliation(s)
| | | | | | - Sid Rao
- Vascular Solutions of North Carolina, Cary, NC, USA
| | - Max Arroyo
- St Bernard’s Heart and Vascular, Jonesboro, AR, USA
| | | | - Osamu Iida
- Kansai Rosai Hospital, Hyogo, Amagasaki, Japan
| | - Ehrin Armstrong
- Rocky Mountain Regional VA Medical Center, Aurora, CO, USA
- Adventist Heart and Vascular Institute, Adventist Health, St Helena, CA, USA (current)
| | | | | | | | - Santhosh J Mathews
- Bradenton Cardiology Center, Manatee Memorial Hospital, Bradenton, FL, USA
| | - Yann Gouëffic
- Groupe Hospitalier Paris Saint Joseph, Paris, Île-de-France, France
| | | | - Ido Weinberg
- VasCore – The Vascular Imaging Core Laboratory, Boston, MA, USA
| | - Duane S Pinto
- Division of Cardiology, Beth Israel Deaconess Medical Center, Boston, MA, USA
| | - Norihiko Ohura
- Kyorin University School of Medicine, Mitaka, Tokyo, Japan
| | - Kara Couch
- George Washington University Hospital, Washington, DC, USA
| | - Jihad A Mustapha
- Michigan State University College of Human Medicine, East Lansing, MI, USA
- Advanced Cardiac and Vascular Centers for Amputation Prevention, Grand Rapids, MI, USA
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24
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Snyder DJ, Zilinyi RS, Pruthi S, George S, Tirziu D, Lansky A, Mintz AJ, Sethi SS, Parikh SA. Percutaneous Transluminal Angioplasty for Infrapopliteal Chronic Limb-Threatening Ischemia: A Systematic Review and Meta-analysis of Primary Patency and Binary Restenosis Rates. J Endovasc Ther 2023:15266028231212133. [PMID: 38008929 DOI: 10.1177/15266028231212133] [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: 11/28/2023]
Abstract
PURPOSE Percutaneous transluminal angioplasty (PTA) remains the mainstay of endovascular therapy for infrapopliteal chronic limb-threatening ischemia (CLTI), but outcomes have not been well characterized using high-quality data. The aim of this meta-analysis was to provide an updated benchmark for rates of primary patency and binary restenosis after PTA using prospectively collected, predominantly core-lab adjudicated randomized controlled trial (RCT) data. MATERIALS AND METHODS MEDLINE, EMBASE, Cochrane Central, and ClinicalTrials.gov were queried for RCTs published through November 2022 using PTA as a control arm and including patients with infrapopliteal CLTI. Studies were excluded if >25% of patients had intermittent claudication, other vessels were included, or primary patency or binary restenosis were not outcomes. Outcomes were analyzed using random effects models. This analysis was publicly registered (PROSPERO ID#394543). No funding was utilized. RESULTS Seventeen RCTs were included (1048 patients, 1279 lesions). Pooled primary patency rates using data from 6 RCTs were 68% at 6 months (95% confidence interval [CI]=45%-84%) and 66% at 12 months (95% CI=51%-79%). Pooled binary restenosis rates using data from 11 RCTs were 54% at 6 months (95% CI=33%-73%) and 60% at 9 to 12 months (95% CI=39%-78%). Significant heterogeneity was present in all outcomes (I2>50%, p<0.0001). Publication bias was not observed (Egger's p>0.1). CONCLUSIONS This meta-analysis provides estimates for binary restenosis and primary patency following PTA utilizing prospectively collected, predominantly core-lab adjudicated data. Results demonstrate 1-year primary patency rates that are 10% to 20% higher than what has been historically used in power calculations. These new estimates will help facilitate more accurate power analysis for future RCTs. CLINICAL IMPACT Rates of primary patency and binary restenosis after percutaneous transluminal angioplasty (PTA) have not been well-described using high-quality data, and investigators have been utilizing estimates of 40% to 50% and 45% to 65%, respectively, when performing power calculations for trials. This meta-analysis demonstrates using high-quality, prospectively collected, and predominantly core-lab adjudicated randomized controlled trial data that actual rates of primary patency are closer to 60% up to 1 year following PTA and provides the first meta-analysis estimate of binary restenosis rates up to 1 year after PTA. These estimates will help facilitate more accurate power calculations for future RCTs in this space.
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Affiliation(s)
- Daniel J Snyder
- Department of Medicine, Columbia University Irving Medical Center, New York-Presbyterian, New York, NY, USA
| | - Robert S Zilinyi
- Division of Cardiology, Department of Medicine, Columbia University Irving Medical Center, New York, NY, USA
| | - Sonal Pruthi
- Division of Cardiology, Department of Medicine, Columbia University Irving Medical Center, New York, NY, USA
| | - Sareena George
- Division of Cardiology, Department of Medicine, Columbia University Irving Medical Center, New York, NY, USA
| | - Daniela Tirziu
- Yale Cardiovascular Research Group, Section of Cardiovascular Medicine, Department of Internal Medicine, Yale University School of Medicine, New Haven, CT, USA
| | - Alexandra Lansky
- Yale Cardiovascular Research Group, Section of Cardiovascular Medicine, Department of Internal Medicine, Yale University School of Medicine, New Haven, CT, USA
| | - Ari J Mintz
- Division of Cardiology, Department of Medicine, Columbia University Irving Medical Center, New York, NY, USA
| | - Sanjum S Sethi
- Division of Cardiology, Department of Medicine, Columbia University Irving Medical Center, New York, NY, USA
| | - Sahil A Parikh
- Division of Cardiology, Department of Medicine, Columbia University Irving Medical Center, New York, NY, USA
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25
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Watson NW, Mosarla RC, Secemsky EA. Endovascular Interventions for Peripheral Artery Disease: A Contemporary Review. Curr Cardiol Rep 2023; 25:1611-1622. [PMID: 37804391 DOI: 10.1007/s11886-023-01973-9] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 09/26/2023] [Indexed: 10/09/2023]
Abstract
PURPOSE OF REVIEW Peripheral artery disease (PAD) is an increasingly prevalent but frequently underdiagnosed condition that can be associated with high rates of morbidity and mortality. While an initial noninvasive approach is the cornerstone of management, revascularization is often pursued for patients with treatment-refractory claudication or chronic limb-threatening ischemia (CLTI). In this review, we discuss the current state of endovascular interventions for PAD and explore the many new emerging technologies. RECENT FINDINGS The last decade has resulted in numerous advances in PAD interventions including the ongoing evolution of drug-coated devices, novel approaches to complex lesions, and contemporary evidence from large clinical trials for CLTI. Advances in endovascular management have allowed for increasingly complex lesions to be tackled percutaneously. Future directions for the field include the continued evolution in device technology, continued development of state-of-the-art techniques to revascularization of complex lesions, and increased collaboration between a largely multidisciplinary field.
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Affiliation(s)
- Nathan W Watson
- Harvard Medical School, Boston, MA, USA
- Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, MA, USA
| | - Ramya C Mosarla
- Division of Cardiology, Department of Medicine, New York University Medical Center, New York, NY, USA
| | - Eric A Secemsky
- Harvard Medical School, Boston, MA, USA.
- Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, MA, USA.
- Division of Cardiology, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, MA, USA.
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26
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Fan W, Tan J, Li L, Feng B, Shi W, Pei J, Yuan G, Yu B. Efficacy and Safety of Absorb Everolimus-Eluting Bioresorbable Vascular Scaffold in Peripheral Artery Disease: A Single-Arm Meta-Analysis. J Endovasc Ther 2023; 30:651-663. [PMID: 35510722 DOI: 10.1177/15266028221091899] [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: 11/15/2022]
Abstract
PURPOSE This study aimed to evaluate the benefits and risks of patients with peripheral artery disease (PAD) treated with Absorb everolimus-eluting bioresorbable vascular scaffold (BVS) by analyzing all the published studies on the clinical characteristics of patients with PAD. MATERIALS AND METHODS PubMed, Embase, and the Cochrane Library were searched for relevant studies. Efficacy, safety, and basic characteristics were analyzed. RESULTS Four studies were included in meta-analysis, including a total number of 155 patients with PAD. The pooled overall primary patency, freedom from target lesion revascularization (TLR), symptom resolution, and wound healing were 90%, 96%, 94%, and 86%, respectively. The pooled perioperative complication and all-cause mortality were 4% and 9%, respectively. Preoperative total occlusion was detected in 43 of 192 lesions (22%). The mean lesion length was 27.26 mm. In terms of comorbidities, the pooled percentage of hypertension, hyperlipidemia, diabetes mellitus, coronary artery disease, chronic kidney disease history, and smoking were 65%, 74%, 49%, 43%, 20%, and 57%, respectively. CONCLUSION Among these studies, hypertension, hyperlipidemia, and diabetes mellitus were the most common comorbidities in patients with PAD. The Absorb everolimus-eluting BVS was safe and showed the favorable clinical outcomes in both patency and TLR, especially in infrapopliteal disease with heavy calcification. The conclusions of this meta-analysis still needed to be verified by more relevant studies with more careful design, more rigorous execution, and larger sample size.
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Affiliation(s)
- Weijian Fan
- Department of Vascular Surgery, Shanghai Pudong Hospital, Fudan University Pudong Medical Center, Shanghai, P.R. China
| | - Jinyun Tan
- Department of Vascular Surgery, Huashan Hospital of Fudan University, Shanghai, P.R. China
- Shanghai Key Laboratory of Vascular Lesions Regulation and Remodeling, Shanghai, P.R. China
| | - Lingyu Li
- National Engineering Research Center of Light Alloy Net Forming and State Key Laboratory of Metal Matrix Composite, Shanghai Jiao Tong University, Shanghai, P.R. China
| | - Boxuan Feng
- National Engineering Research Center of Light Alloy Net Forming and State Key Laboratory of Metal Matrix Composite, Shanghai Jiao Tong University, Shanghai, P.R. China
| | - Weihao Shi
- Department of Vascular Surgery, Huashan Hospital of Fudan University, Shanghai, P.R. China
| | - Jia Pei
- National Engineering Research Center of Light Alloy Net Forming and State Key Laboratory of Metal Matrix Composite, Shanghai Jiao Tong University, Shanghai, P.R. China
| | - Guangyin Yuan
- National Engineering Research Center of Light Alloy Net Forming and State Key Laboratory of Metal Matrix Composite, Shanghai Jiao Tong University, Shanghai, P.R. China
| | - Bo Yu
- Department of Vascular Surgery, Shanghai Pudong Hospital, Fudan University Pudong Medical Center, Shanghai, P.R. China
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27
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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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28
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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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29
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Abstract
As the number of patients affected by peripheral arterial disease continues to increase, new technical approaches and devices have been developed to provide effective and durable treatment options that will lead to improved outcomes. While the mainstay of endovascular intervention remains mostly balloon-based, several innovative techniques and technologies are in development that may provide new solutions. This review highlights recent endovascular advancements in the management of chronic limb-threatening ischemia and additional adjunctive devices that are needed to improve lesion patency, reduce the need for reintervention, and lead to better patient-centered functional outcomes.
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Affiliation(s)
- Arash Fereydooni
- Division of Vascular and Endovascular Surgery, Department of Surgery, Stanford University, Stanford, CA, USA
| | - Venita Chandra
- Division of Vascular and Endovascular Surgery, Department of Surgery, Stanford University, Stanford, CA, USA; Stanford School of Medicine, 780 Welch Road, Palo Alto, CA 94304, USA.
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30
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Dolmatch B, Cabrera T, Pergola P, Balamuthusamy S, Makris A, Cooper R, Moore E, Licht J, Macaulay E, Maleux G, Pfammatter T, Settlage R, Cristea E, Lansky A. Prospective, randomized, multicenter clinical study comparing a self-expanding covered stent to percutaneous transluminal angioplasty for treatment of upper extremity hemodialysis arteriovenous fistula stenosis. Kidney Int 2023; 104:189-200. [PMID: 36990214 DOI: 10.1016/j.kint.2023.03.015] [Citation(s) in RCA: 10] [Impact Index Per Article: 5.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/07/2022] [Revised: 03/02/2023] [Accepted: 03/09/2023] [Indexed: 03/29/2023]
Abstract
Use of a covered stent after percutaneous transluminal angioplasty (PTA) was compared to PTA alone for treatment of upper extremity hemodialysis patients with arteriovenous fistula (AVF) stenoses. Patients with AVF stenosis of 50% or more and evidence of AVF dysfunction underwent treatment with PTA followed by randomization of 142 patients to include a covered stent or 138 patients with PTA alone. Primary outcomes were 30-day safety, powered for noninferiority, and six-month target lesion primary patency (TLPP), powered to test whether TLPP after covered-stent placement was superior to PTA alone. Twelve-month TLPP and six-month access circuit primary patency (ACPP) were also hypothesis tested while additional clinical outcomes were observed through two years. Safety was significantly non-inferior while six- and 12-month TLPP were each superior for the covered stent group compared to PTA alone (six months: 78.7% versus 55.8%; 12 months: 47.9% versus 21.2%, respectively). ACPP was not statistically different between groups at six-months. Observed differences at 24 months favored the covered-stent group: 28.4% better TLPP, fewer target-lesion reinterventions (1.6 ± 1.6 versus 2.8 ± 2.0), and a longer mean time between target-lesion reinterventions (380.4 ± 249.5 versus 217.6 ± 158.4 days). Thus, our multicenter, prospective, randomized study of a covered stent used to treat AVF stenosis demonstrated noninferior safety with better TLPP and fewer target-lesion reinterventions than PTA alone through 24 months.
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Affiliation(s)
- Bart Dolmatch
- Interventional Radiology, Palo Alto Medical Foundation, Mountain View, California, USA; Interventional Radiology, El Camino Hospital, Mountain View, California, USA.
| | | | | | - Saravanan Balamuthusamy
- Tarrant Nephrology Associates, Fort Worth, Texas, USA; Department of Medicine and Nephrology, Texas Christian University School of Medicine, Fort Worth, Texas, USA
| | | | - Randy Cooper
- Southwest Kidney Institute Vascular Center, Tempe, Arizona, USA
| | - Erin Moore
- Cardiothoracic & Vascular Surgical Associates, Jacksonville, Florida, USA; Department of Vascular Surgery, Baptist Medical Center Jacksonville, Jacksonville, Florida, USA
| | - Jonah Licht
- Providence Interventional Associates, Providence, Rhode Island, USA; Division of Nephrology, Warren Alpert Medical School of Brown University, Providence, Rhode Island, USA
| | - Ewan Macaulay
- Department of Vascular Surgery, Royal Adelaide Hospital, Adelaide, South Australia, Australia
| | - Geert Maleux
- Department of Vascular and Interventional Radiology, University Hospitals KU Leuven, Leuven, Belgium
| | - Thomas Pfammatter
- Department of Diagnostic and Interventional Radiology, University of Zürich Hospital, Zürich, Switzerland
| | - Richard Settlage
- Medical Affairs Department, Becton, Dickinson and Company, Colorado Springs, Colorado, USA
| | - Ecaterina Cristea
- Section of Cardiovascular Medicine, Yale School of Medicine, New Haven, Connecticut, USA
| | - Alexandra Lansky
- Section of Cardiovascular Medicine, Yale School of Medicine, New Haven, Connecticut, USA
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Varcoe RL, Parikh SA, DeRubertis BG, Jones-McMeans JM, Teraphongphom NT, Wang J, Kolluri R, Weinberg I, Holden AH, Garcia-Garcia HM, Kum SW, Bonaca MP, Bajakian DR, Garcia LA, Krishnan P, Armstrong E, Shishehbor MH, Rundback J, Metzger DC. Evaluation of an Infrapopliteal Drug-Eluting Resorbable Scaffold: Design Methodology for the LIFE-BTK Randomized Controlled Trial. JOURNAL OF THE SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY & INTERVENTIONS 2023; 2:100964. [PMID: 39131658 PMCID: PMC11307544 DOI: 10.1016/j.jscai.2023.100964] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Subscribe] [Scholar Register] [Received: 02/04/2023] [Revised: 03/15/2023] [Accepted: 03/17/2023] [Indexed: 08/13/2024]
Abstract
Background Critical limb-threatening ischemia (CLTI) is a severe condition characterized by rest pain and ischemic tissue loss that affects 5% to 10% of people with peripheral artery disease. In the United States, there are few Food and Drug Administration-approved devices for the primary treatment of arteries below-the-knee (BTK). Unfortunately, all suffer from high restenosis rates due to intimal hyperplasia, elastic recoil, and untreated dissection because of a lack of scaffolding. The Esprit BTK system is a resorbable, drug-eluting scaffold device with the potential to address an unmet need in people suffering from CLTI because of infrapopliteal atherosclerosis. The LIFE-BTK (pivotaL Investigation of saFety and Efficacy of drug-eluting resorbable scaffold treatment-Below The Knee) randomized controlled trial (RCT) is a prospectively designed premarket evaluation of the Esprit BTK drug-eluting resorbable scaffold used in the treatment of those patients. Methods The LIFE-BTK trial enrolled 261 subjects with CLTI for the RCT and a further 7 subjects for a pharmacokinetic substudy. The objective of the RCT was to evaluate the safety and efficacy of the Esprit BTK scaffold compared to percutaneous transluminal angioplasty. The primary efficacy end point was a composite of limb salvage and primary patency at 12 months. The primary safety end point is freedom from major adverse limb events and peri-operative death at 6 months and 30 days, respectively. Clinical follow-up care is planned for 5 years. Conclusions Novel devices must be tested in RCTs to evaluate their safety and efficacy compared to the standard of care if we are to improve outcomes for this challenging group of patients.
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Affiliation(s)
- Ramon L. Varcoe
- The Prince of Wales Hospital, University of New South Wales, Randwick, New South Wales, Australia
| | - Sahil A. Parikh
- Columbia University Vagelos College of Physicians and Surgeons, New York, New York
| | | | | | | | - Jin Wang
- Abbott Vascular, Santa Clara, California
| | | | | | - Andrew H. Holden
- Auckland Hospital, University of Auckland, Grafton, Auckland, New Zealand
| | | | | | - Marc P. Bonaca
- Cardiovascular Division, CPC Clinical Research, University of Colorado School of Medicine, Aurora, Colorado
| | - Danielle R. Bajakian
- Columbia University Vagelos College of Physicians and Surgeons, New York, New York
| | - Lawrence A. Garcia
- Vascular Care Group, Tufts University School of Medicine, Boston, Massachusetts
| | | | | | - Mehdi H. Shishehbor
- University Hospitals Harrington Heart and Vascular Institute, Cleveland, Ohio
| | - John Rundback
- Advanced Interventional and Vascular Services LLP, Teaneck, New Jersey
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Dadrass F, Raja SC, Lookstein R. Below-the-Knee Stents and Scaffolds: A Comprehensive Review. Semin Intervent Radiol 2023; 40:167-171. [PMID: 37333740 PMCID: PMC10275668 DOI: 10.1055/s-0043-57263] [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
Below-the-knee intervention of chronic limb-threatening ischemia is an area of increasing interest. Due to lower morbidity and possibly better clinical outcomes, endovascular techniques have become increasingly important in this patient population many of who have limited surgical options. This article serves as a review of existing stent and scaffolding devices utilized for infrapopliteal disease. The authors will additionally discuss current indications and review studies that are investigating novel materials used in treating infrapopliteal arterial disease.
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Affiliation(s)
- Farnaz Dadrass
- Department of Diagnostic, Molecular and Interventional Radiology, Icahn School of Medicine at Mount Sinai, New York, New York
| | - Sahitya C. Raja
- Department of Vascular and Interventional Radiology, Rush University Medical Center, Chicago, Illinois
| | - Robert Lookstein
- Department of Diagnostic, Molecular and Interventional Radiology, Icahn School of Medicine at Mount Sinai, New York, New York
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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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Effectiveness and Safety of Atherectomy versus Plain Balloon Angioplasty for Limb Salvage in Tibioperoneal Arterial Disease. J Vasc Interv Radiol 2023; 34:428-435. [PMID: 36442743 DOI: 10.1016/j.jvir.2022.11.021] [Citation(s) in RCA: 2] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/19/2022] [Revised: 11/02/2022] [Accepted: 11/19/2022] [Indexed: 11/27/2022] Open
Abstract
PURPOSE To evaluate the effectiveness and safety of atherectomy versus plain balloon angioplasty (POBA) for treatment of critical limb ischemia (CLI) due to tibioperoneal arterial disease (TPAD). MATERIALS AND METHODS Patients enrolled in the Vascular Quality Initiative registry who had CLI (Rutherford Class 4-6) and underwent atherectomy versus POBA alone for isolated TPAD were retrospectively identified. Of eligible patients, a cohort of 2,908 patients was propensity matched 1:1 by clinical and angiographic characteristics. The atherectomy group comprised 1,454 patients with 2,183 arteries treated, and the POBA group comprised 1,454 patients with 2,141 arteries treated. The primary study endpoint was major ipsilateral limb amputation. Secondary endpoints were minor ipsilateral amputations, any ipsilateral amputation, primary patency, target vessel reintervention (TVR), and wound healing at 12 months. RESULTS The median follow-up period was 507 days, the mean patient age was 69 years ± 11.7, and the mean occluded length was 6.9 cm ± 6.5. There was a trend toward higher technical success rates with atherectomy than with POBA (92.9% vs 91.0%, respectively; P = .06). The rates of major adverse events during the procedure were not significantly different. The 12-month major amputation rate was similar in the atherectomy and POBA groups (4.5% vs 4.6%, respectively; P = .92; odds ratio, 0.97; 95% CI, 0.68-1.37). There was no difference in 12-month TVR (17.9% vs 17.8%; P = .97) or primary patency (56.4% vs 54.5%; P = .64) between the atherectomy and POBA groups. CONCLUSIONS In a large national registry, treatment of CLI from TPAD using atherectomy versus POBA showed no significant differences in procedural adverse events, major amputations, TVR, or vessel patency at 12 months.
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Zuzek Z, Arora S, Helmy I, Jani C, Jaswaney R, Patel K, Patel HP, Patel M, Osman MN, Li J, Shishehbor MH. Underutilization of Drug-Eluting Stents in Infrapopliteal Intervention for Chronic Limb-Threatening Ischemia. J Endovasc Ther 2023; 30:45-56. [PMID: 35075941 DOI: 10.1177/15266028211068763] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/25/2023]
Abstract
PURPOSE Multiple randomized clinical trials have shown superiority of drug-eluting stents (DES) over bare-metal stents (BMS) for infrapopliteal disease. However, real-world data on DES utilization and outcomes in infrapopliteal chronic limb-threatening ischemia (CLTI) patients are unknown. MATERIALS AND METHODS We utilized the Nationwide Readmission Database (NRD) from 2016 to 2017 to extract patients undergoing infrapopliteal intervention with stents (BMS and DES) for CLTI using appropriate ICD-10 codes. Multilevel logistic regression with hospital ID as random effect was used to assess DES utilization. Primary outcome was the composite of target limb major amputation (TLmajA) and target limb revascularization (TLR). Multivariate Cox-proportional hazard regression was used to adjust for confounders. RESULTS Our study included a total of 1817 patients. Of these patients, 1056 patients (58.1%) received DES; DES utilization was stable (relative change: +2.5%, p-trend: 0.867) between 2016 and 2017 and was higher in teaching hospitals (adjusted odds ratio [aOR] = 1.28, 95% CI = 1.03-1.61, p=0.029] and medium (aOR = 3.13, 95% CI = 2.17-4.55, p≤0.001) and large (aOR = 1.56, 95% CI = 1.14-2.17, p=0.005) bed-sized hospitals. Inter-class correlation was 0.44 suggesting ~44% variation in DES utilization between any 2 random hospitals; DES was associated with lower rate of the primary composite outcome (aHR = 0.75, 95% CI = 0.62-0.92, p=0.004) compared with BMS. CONCLUSION In patients undergoing infrapopliteal intervention for CLTI, DES demonstrated significant underutilization despite supportive evidence of their superiority compared with BMS; DES was associated with improvement in the primary composite outcome compared with BMS.
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Affiliation(s)
- Zachary Zuzek
- Harrington Heart and Vascular Institute, Case Western Reserve University School of Medicine, University Hospitals Cleveland Medical Center, Case Western Reserve University, Cleveland, OH, USA
| | - Shilpkumar Arora
- Harrington Heart and Vascular Institute, Case Western Reserve University School of Medicine, University Hospitals Cleveland Medical Center, Case Western Reserve University, Cleveland, OH, USA
| | - Irfan Helmy
- Harrington Heart and Vascular Institute, Case Western Reserve University School of Medicine, University Hospitals Cleveland Medical Center, Case Western Reserve University, Cleveland, OH, USA
| | - Chinmay Jani
- Mount Auburn Hospital, Harvard Medical School, Cambridge, MA, USA
| | - Rahul Jaswaney
- Harrington Heart and Vascular Institute, Case Western Reserve University School of Medicine, University Hospitals Cleveland Medical Center, Case Western Reserve University, Cleveland, OH, USA
| | | | | | - Mohini Patel
- Boston University School of Public Health, Boston, MA, USA
| | - Mohammed Najeeb Osman
- Harrington Heart and Vascular Institute, Case Western Reserve University School of Medicine, University Hospitals Cleveland Medical Center, Case Western Reserve University, Cleveland, OH, USA
| | - Jun Li
- Harrington Heart and Vascular Institute, Case Western Reserve University School of Medicine, University Hospitals Cleveland Medical Center, Case Western Reserve University, Cleveland, OH, USA
| | - Mehdi H Shishehbor
- Harrington Heart and Vascular Institute, Case Western Reserve University School of Medicine, University Hospitals Cleveland Medical Center, Case Western Reserve University, Cleveland, OH, USA
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Ali I, Arslan B, Beasley R, Bechara C, Berens P, Chandra V, Chohan O, Cote C, Dadrass F, Dhand S, Dua A, Elmasri F, Fischer B, Hallak AO, Han DK, Heaney C, Herman K, Jaffer U, Jessula S, Kayssi A, Keefe N, Khurana N, Kohi M, Korff RA, Krishnan P, Kumar A, Laurich C, Lookstein RA, Madassery S, Maringo A, Martin J, Mathews SJ, McCon RP, Mehta A, Melton JG, Miranda J, Mize A, Baker MM, Mustapha JA, Nagi M, N’Dandu Z, Osman M, Parsons BP, Posham R, Raja A, Riaz R, Richard M, Rundback JH, Saab FA, Salazar G, Schiro BJ, Secemsky E, Sommerset J, Tabriz DM, Taylor J, Thomas A, Tummala S, Tummala V, Uddin OM, Van Den Berg J, Watts M, Wiechmann BN, Ysa A. Arterial Revascularization. LIMB PRESERVATION FOR THE VASCULAR SPECIALIST 2023:77-249. [DOI: 10.1007/978-3-031-36480-8_6] [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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Tigkiropoulos K, Abatzis-Papadopoulos M, Sidiropoulou K, Stavridis K, Karamanos D, Lazaridis I, Saratzis N. Polymer Free Amphilimus Drug Eluting Stent for Infrapopliteal Arterial Disease in Patients with Critical Limb Ischemia: A New Device in the Armamentarium. MEDICINA (KAUNAS, LITHUANIA) 2022; 59:39. [PMID: 36676663 PMCID: PMC9866247 DOI: 10.3390/medicina59010039] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Figures] [Subscribe] [Scholar Register] [Received: 10/30/2022] [Revised: 12/19/2022] [Accepted: 12/21/2022] [Indexed: 12/28/2022]
Abstract
Background and Objectives: Endovascular technologies have significantly improved the outcome of patients with critical limb ischemia (CLI). Drug eluting stents (DES) have documented their efficacy against percutaneous transluminal angioplasty (PTA) and bare metal stents (BMS) in infrapopliteal arterial occlusive disease. However, late in-stent neoatherosclerosis may lead to vascular lumen loss and eventually thrombosis. Polymer free DES constitute a new technology aiming to improve long term patency which their action is still under investigation. The purpose of this study is to report the mechanism of action and to provide a literature review of a novel polymer free amphilimus eluting stent (Cre8, Alvimedica, Instabul, Turkey) in infrapopliteal arterial disease. Methods: Publications listed in electronic databases, European Union Drug Regulating Authorities Clinical Trials Database, as well as scientific programmes of recent interventional vascular conferences were searched. Three studies were included. We analyzed primary and secondary patency, major amputation rate, freedom from CD-TLR, and mortality. Results: Cre8 was implanted in 79 patients with CLI. Most of the patients (n = 65) were Rutherford class 5-6 (82.3%), and diabetes mellitus (DM) was present in 66 patients (83.5%). Mean primary patency was 82.5% at 12 months. Mean lesion stented length was 20 mm and 35 mm in two studies. Mean limb salvage was 91.3% at 12 months. Freedom from CD-TLR was reported in two out of the three studies and was 96% and 83.8%. Mortality was 15% and 23.8% in the same studies, whilst it was not reported in one study. Conclusion: Stenting of infrapopliteal arteries with Cre8 is safe and feasible in patients with CLI and diabetes. All studies have shown very good primary patency and freedom from CD-TLR at 12 and 24 months. Larger observational prospective studies and randomized trials are necessary to establish long term effectiveness and clinical outcomes using the non-polymer Cre8 DES.
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Affiliation(s)
- Konstantinos Tigkiropoulos
- Division of Vascular Surgery, 1st Surgical Department, Faculty of Health Sciences, Aristotle University, Papageorgiou General Hospital, 56429 Thessaloniki, Greece
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Guo J, Ning Y, Wang H, Li Y, Su Z, Zhang F, Wu S, Guo L, Gu Y. The efficacy and safety of different endovascular modalities for infrapopliteal arteries lesions: A network meta-analysis of randomized controlled trials. Front Cardiovasc Med 2022; 9:993290. [PMID: 36439998 PMCID: PMC9682151 DOI: 10.3389/fcvm.2022.993290] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/13/2022] [Accepted: 10/27/2022] [Indexed: 01/07/2025] Open
Abstract
BACKGROUND Endovascular treatment has become the first-line therapy for infrapopliteal artery occlusive disease (IPOD), while the optimal endovascular method remains to be determined. We performed a network meta-analysis (NWM) of randomized controlled trials (RCTs) to simultaneously compare the outcomes of different endovascular modalities for IPOD. METHODS AND RESULTS The Pubmed, Embase, and Cochrane databases were used as data sources. The NWM approach used random-effects models based on the frequentist framework. In total, 22 eligible RCTs (44 study arms; 1,348 patients) involving nine endovascular modalities or combinations [balloon angioplasty (BA), drug-coated balloon (DCB), drug-eluting stent (DES), atherectomy device + BA (AD + BA), AD + DCB, balloon-expandable bare metal stent (BMS), self-expanding stent (SES), absorbable metal stents (AMS), and inorganics-coated stent (ICS)] were included. BA had a lower 12-month primary patency rate than DCB (RR 0.50, CI 0.27, 0.93) and AD + DCB (RR 0.34, CI 0.12, 0.93). AD + DCB decreased 6-month TLR compared with AMS (RR 0.15, CI 0.03, 0.90), and DES decreased it compared with BMS (RR 0.25, CI 0.09, 0.71). DCB had a lower 6-month TLR rate than AMS (RR 0.26, CI 0.08, 0.86) and BA (RR 0.51, CI 0.30, 0.89). BA had a higher 12-month TLR rate than DCB (RR 1.76, CI 1.07, 2.90). According to the value of the surface under the cumulative ranking curve (SUCRA), AD + DCB was considered the best treatment in terms of primary patency at 6 months (SUCRA = 87.5) and 12 months (SURCA = 91). AD + BA was considered the best treatment in terms of 6-month TLR (SUCRA = 83.1), 12-month TLR (SURCA = 75.8), and 12-month all-cause mortality (SUCRA = 92.5). In terms of 12-month major amputation, DES was considered the best treatment (SUCRA = 78.6), while AD + DCB was considered the worst treatment (SUCRA = 28.8). Moreover, AD + BA always ranks higher than AD + DCB in the comparison including these two combinations. Subgroup analyses of modalities without stenting did not significantly change the primary outcomes. CONCLUSION ADs showed noteworthy advantages in multiple terms for IPOD except for 12-month major amputation. AD + BA may be a better method for IPOD than AD + DCB. The efficacy and safety of ADs are worthy of further investigation. SYSTEMATIC REVIEW REGISTRATION [https://www.crd.york.ac.uk/prospero/], identifier [CRD42022331626].
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Affiliation(s)
- Julong Guo
- Department of Vascular Surgery, Xuanwu Hospital, Capital Medical University, Beijing, China
| | - Yachan Ning
- Department of Intensive Care Medicine, Xuanwu Hospital, Capital Medical University, Beijing, China
| | - Hui Wang
- Department of Vascular Surgery, Xuanwu Hospital, Capital Medical University, Beijing, China
| | - Yu Li
- Department of General Surgery, Xuanwu Hospital, Capital Medical University, Beijing, China
| | - Zhixiang Su
- Department of Vascular Surgery, Xuanwu Hospital, Capital Medical University, Beijing, China
| | - Fan Zhang
- Department of Vascular Surgery, Xuanwu Hospital, Capital Medical University, Beijing, China
| | - Sensen Wu
- Department of Vascular Surgery, Xuanwu Hospital, Capital Medical University, Beijing, China
| | - Lianrui Guo
- Department of Vascular Surgery, Xuanwu Hospital, Capital Medical University, Beijing, China
| | - Yongquan Gu
- Department of Vascular Surgery, Xuanwu Hospital, Capital Medical University, Beijing, China
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Abstract
Endovascular revascularization strategies have advanced tremendously over the years and are now often considered first line for treatment of peripheral arterial disease. Drug-eluting stents (DESs) have been developed as one of the tools to overcome the limitations of elastic recoil and neointimal hyperplasia observed with balloon angioplasty and bare metal stents. While these stents have been extremely successful in coronary revascularization, they have not translated as effectively to the peripheral arteries which differ in their unique mechanical environments and differences in vessel and lesion composition. DESs, through their embedded pharmaceutical agent, seek to inhibit vascular smooth muscle cell (VSMC) proliferation and migration. Paclitaxel, sirolimus, and its derivatives (-limus family) achieve VSMC inhibition through unique mechanisms. Several clinical trials have been performed to evaluate the use of DES in the femoropopliteal and infrapopliteal territory and have demonstrated overall decrease in revascularization rates and improved clinical outcomes.
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Affiliation(s)
- Chetan Velagapudi
- Department of Vascular and Interventional Radiology, Rush University Medical Center, Chicago, Illinois
| | - Sreekumar Madassery
- Department of Vascular and Interventional Radiology, Rush University Medical Center, Chicago, Illinois
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Anti-Restenotic Technologies in the SFA: Balloons and Stents. Tech Vasc Interv Radiol 2022; 25:100842. [PMID: 35842257 DOI: 10.1016/j.tvir.2022.100842] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/19/2022]
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Cai H, Dong J, Ye Y, Song Q, Lu S. Safety and Efficacy of Drug-Coated Balloon in the Treatment of Below-The-Knee Artery: A Meta-analysis. J Surg Res 2022; 278:303-316. [PMID: 35660302 DOI: 10.1016/j.jss.2022.04.055] [Citation(s) in RCA: 11] [Impact Index Per Article: 3.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/17/2021] [Revised: 02/19/2022] [Accepted: 04/19/2022] [Indexed: 12/21/2022]
Abstract
INTRODUCTION Chronic limb threat ischemia is associated with cardiovascular events, resulting in high amputation, morbidity and mortality rates. This study aims to accomplish a comprehensive summary of randomized controlled trials and single-center trials related to drug-coated balloons (DCBs) in the treatment of below-the-knee (BTK) artery disease, and to provide a recommendation for the application of DCBs in BTK artery disease. METHODS Five electronic databases were used to retrieve relevant articles on the safety and effectiveness of DCBs in the treatment of BTK artery disease. A random-effects model was applied to calculate the standard mean deviation, odds ratio (OR) and their 95% of confidence interval (CI). RESULTS As of April 8, 2021, a total of 241 articles were retrieved, but only 13 articles were finally included for meta-analysis. The 12 mo follow-up study found that major adverse events , all-cause mortality, major amputation ,and target lesion revascularization had no statistically significant difference between the DCBs group and the control group (target lesion revascularization: OR = 0.68, 95% CI: 0.36, 1.31; all-cause mortality: OR = 1.30, 95% CI: 0.69, 2.46; major amputation: OR = 1.34, 95% CI: 0.64, 2.79; target lesion revascularization: OR = 0.72, 95% CI: 0.35, 1.45). CONCLUSIONS The meta-analysis results of randomized controlled trials focusing on comparing DCBs and other treatments suggest that DCBs do not have significant advantages in the treatment of BTK artery disease when compare with percutaneous transluminal angioplasty (PTA), but better than control intervention except PTA in both safety and efficacy end points. However, the results of meta-analysis of single-arm trial reported DCBs in treating BTK artery lesions are significantly improved compared with the meta-analysis concentrating on PTA.
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Affiliation(s)
- Hui Cai
- Department of Vascular Surgery, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China
| | - Jian Dong
- Department of Vascular Surgery, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China
| | - Yuanpeng Ye
- Department of Vascular Surgery, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China
| | - Qiang Song
- Department of Structural Heart Disease, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China
| | - Shaoying Lu
- Department of Vascular Surgery, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China.
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Mono or Dual Antiplatelet Therapy for Treating Patients with Peripheral Artery Disease after Lower Extremity Revascularization: A Systematic Review and Meta-Analysis. Pharmaceuticals (Basel) 2022; 15:ph15050596. [PMID: 35631422 PMCID: PMC9144146 DOI: 10.3390/ph15050596] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/11/2022] [Revised: 05/02/2022] [Accepted: 05/09/2022] [Indexed: 12/24/2022] Open
Abstract
The efficacy of dual antiplatelet therapy (DAPT) for patients with peripheral artery disease (PAD) after lower-limb intervention remains controversial. Currently, the prescription of DAPT after an intervention is not fully recommended in guidelines due to limited evidence. This study compares and analyzes the prognosis for symptomatic PAD patients receiving DAPT versus monotherapy after lower-limb revascularization. Up to November 2021, PubMed/MEDLINE, Embase, and Cochrane databases were searched to identify studies reporting the efficacy, duration, and bleeding complications when either DAPT or monotherapy were used to treat PAD patients after revascularization. Three randomized controlled trials and seven nonrandomized controlled trials were included in our study. In total, 74,651 patients made up these ten studies. DAPT in PAD patients after intervention was associated with lower rates of all-cause mortality (HR = 0.86; 95% CI, 0.79−0.94; p < 0.01), major adverse limb events (HR = 0.60; 95% CI, 0.47−0.78; p < 0.01), and major amputation (HR = 0.78; 95% CI, 0.64−0.96) when follow-up was for more than 1-year. DAPT was not associated with major bleeding events when compared with monotherapy (OR = 1.22; 95% CI, 0.69−2.18; p = 0.50) but was associated with a higher rate of minor bleeding as a complication (OR = 2.54; 95% CI, 1.59−4.08; p < 0.01). More prospective randomized studies are needed to provide further solid evidence regarding the important issue of prescribing DAPT.
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Heiss C, Olinic DM, Belch JJF, Brodmann M, Mazzolai L, Stanek A, Madaric J, Krentz A, Schlager O, Lichtenberg M, Frank U. Management of chronic peripheral artery disease patients with indication for endovascular revascularization. VASA 2022; 51:121-137. [PMID: 35418243 DOI: 10.1024/0301-1526/a000998] [Citation(s) in RCA: 17] [Impact Index Per Article: 5.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/24/2022]
Abstract
With an increasing global burden of patients with chronic peripheral artery disease (PAD) the safe and effective provision of lower limb revascularisation is a growing medical need. Endovascular procedures for the treatment of PAD have become a crucial cornerstone of modern vascular medicine, and the first line revascularisation approach if technically feasible and taking patient choice into consideration. With the increasing age of patients with PAD and the increasing number of comorbidities open vascular surgery is also often not feasible. We outline a framework of key messages, endorsed by the board of the European Society of Vascular Medicine for pre-, peri- and post procedural management of patients requiring endovascular arterial procedures of the lower limbs. These key messages emphasize the important and increasing role of interventional vascular physicians.
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Affiliation(s)
- Christian Heiss
- Department of Clinical and Experimental Medicine, University of Surrey, Faculty of Health and Medical Sciences, Guildford, United Kingdom.,Department of Vascular Medicine, Surrey and Sussex Healthcare NHS Trust, Redhill, United Kingdom.,The authors contributed equally
| | - Dan-Mircea Olinic
- Iuliu Hatieganu University of Medicine and Pharmacy, Emergency Hospital, Medical Clinic no. 1, Cluj-Napoca, Romania.,The authors contributed equally
| | - Jill J F Belch
- Institute of Cardiovascular Research, University of Dundee, Ninewells Hospital and Medical School, Dundee, United Kingdom
| | - Marianne Brodmann
- Division of Angiology, Department of Internal Medicine, Medical University, Graz, Austria
| | - Lucia Mazzolai
- Division of Angiology, Heart and Vessel Department, Lausanne University Hospital, Lausanne, Switzerland
| | - Agata Stanek
- Department of Internal Diseases, Angiology and Physical Medicine, Medical University of Silesia, Bytom, Poland
| | - Juraj Madaric
- Clinic of Angiology, National Cardiovascular Institute, Bratislava, Slovakia
| | - Andrew Krentz
- Institute for Cardiovascular & Metabolic Research, University of Reading, UK
| | - Oliver Schlager
- Division of Angiology. Department of Medicine II, Medical University of Vienna, Vienna, Austria
| | | | - Ulrich Frank
- Department of Angiology, Cantonal Hospital of Grisons, Chur, Switzerland.,The authors contributed equally
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Feldman ZM, Mohapatra A. Endovascular Management of Complex Tibial Lesions. Semin Vasc Surg 2022; 35:190-199. [PMID: 35672109 DOI: 10.1053/j.semvascsurg.2022.04.008] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/02/2022] [Revised: 04/12/2022] [Accepted: 04/13/2022] [Indexed: 11/11/2022]
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Adams GL, Lichtenberg M, Wissgott C, Schmidt A, Tarra T, Matricardi S, Geraghty PJ. Twenty-Four Month Results of Tack-Optimized Balloon Angioplasty Using the Tack Endovascular System in Below-the-Knee Arteries. J Endovasc Ther 2022; 30:393-400. [PMID: 35352604 DOI: 10.1177/15266028221083462] [Citation(s) in RCA: 3] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/16/2022]
Abstract
PURPOSE To report 24 month safety and efficacy of the Tack Endovascular System for treatment of post-percutaneous transluminal angioplasty (PTA) infrapopliteal dissections in patients with critical limb-threatening ischemia (CLTI). MATERIALS AND METHODS The Tack-Optimized Balloon Angioplasty (TOBA) II below-the-knee (BTK) study was a prospective, multicenter, single-arm evaluation of the Tack Endovascular system for post-PTA infrapopliteal dissection repair. Patients with Rutherford Clinical Category (RC) 3 to 5 and a post-PTA dissection(s) of the BTK arteries were enrolled. The 30 day primary safety endpoint was a composite of major adverse limb events (MALE) and all-cause perioperative death (POD). The primary effectiveness endpoint was a composite of MALE at 6 months and 30 day POD. Outcomes were assessed as observational endpoints at 24 months. RESULTS Tack-Optimized Balloon Angioplasty II BTK enrolled 233 patients; all patients had a post-PTA dissection(s) and received ≥1 Tack implant (range, 1-16). Mean age was 74.4±10.0 years and 67.4% were men. Most patients had CLTI (RC 3: 16.3%; RC 4/5: 83.7%). Mean target lesion length was 80±49 mm. Moderate to severe calcium was present in 89 (35.8%) lesions and total occlusions were present in 118 (47.6%) lesions. Kaplan-Meier freedom from MALE at 24 months + POD at 30 days was 92.2% and 24 month freedom from clinically-driven target lesions revascularization was 73.6%. Kaplan-Meier target limb salvage was 95.7% and amputation-free survival was 75.4%. Improvements in functional status and quality of life were observed through 24 months. CONCLUSION The TOBA II BTK study demonstrated sustained safety and efficacy through 24 months in patients treated for post-PTA dissection(s) of BTK lesions. CLINICAL TRIAL REGISTRATION ClinicalTrials.gov identifier NCT02942966.
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Affiliation(s)
| | | | - Christian Wissgott
- Institute for Diagnostic and Interventional Radiology, Westküstenklinikum Heide, Heide, Germany
| | - Andrej Schmidt
- Department of Angiology, University Hospital Leipzig, Leipzig, Germany
| | | | | | - Patrick J Geraghty
- Section of Vascular Surgery, Department of Surgery, Washington University in St. Louis, St. Louis, MO, USA
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Sivapragasam N, Matchar DB, Zhuang KD, Patel A, Pua U, Win HH, Chandramohan S, Venkatanarasimha N, Chua JME, Tan GWL, Irani FG, Leong S, Tay KH, Chong TT, Tan BS. Cost-Effectiveness of Drug-Coated Balloon Angioplasty Versus Conventional Balloon Angioplasty for Treating Below-the-Knee Arteries in Chronic Limb-Threatening Ischemia: The SINGA-PACLI Trial. Cardiovasc Intervent Radiol 2022; 45:1663-1669. [PMID: 35237860 DOI: 10.1007/s00270-022-03073-7] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/11/2021] [Accepted: 01/27/2022] [Indexed: 11/27/2022]
Abstract
PURPOSE Drug-coated balloon angioplasty (DCBA) has been studied as a potentially superior option compared to conventional percutaneous transluminal angioplasty (PTA) in treating below-the-knee (BTK) arteries in chronic limb-threatening ischemia (CLTI). The aim of this study is to examine the cost-effectiveness of DCBA versus PTA in BTK arteries based on a randomized controlled trial. MATERIAL AND METHODS A prospective economic study was embedded in a randomized controlled trial of 138 patients with CLTI. Resource use and health outcomes were assessed at baseline, and at 3, 6 and 12 months post-intervention. Costs were calculated from a societal perspective and health outcomes measured using quality-adjusted life years with probabilistic sensitivity analysis performed to account for subject heterogeneity. RESULTS Compared with participants randomized to receive PTA, participants randomized to DCBA gained an average baseline-adjusted quality-adjusted life years (QALYs) of .012 while average total costs were USD$1854 higher; this translates to an incremental cost-effectiveness ratio (ICER) of US$154,500 additional cost per QALY gained. However, the estimate of ICER had substantial variance with only 48% of bootstrap ICERs meeting a benchmark threshold of US$57,705 (the average gross domestic product (GDP) per capita of Singapore). CONCLUSION The use of DCBA in BTK arteries in CLTI patients was not cost-effective compared with PTA. LEVEL OF EVIDENCE 2, Randomized trial.
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Affiliation(s)
- Nirmali Sivapragasam
- Programme in Health Services and Systems Research, Duke-NUS Medical School, 8 College Road, Singapore, 169857, Singapore.
| | - David B Matchar
- Programme in Health Services and Systems Research, Duke-NUS Medical School, 8 College Road, Singapore, 169857, Singapore
| | - Kun Da Zhuang
- Department of Vascular and Interventional Radiology, Division of Radiological Sciences, Singapore General Hospital, Radiological Sciences Academic Clinical Programme, Singhealth-Duke-NUS Academic Medical Centre, Outram Road, Singapore, 169608, Singapore
| | - Ankur Patel
- Department of Vascular and Interventional Radiology, Division of Radiological Sciences, Singapore General Hospital, Radiological Sciences Academic Clinical Programme, Singhealth-Duke-NUS Academic Medical Centre, Outram Road, Singapore, 169608, Singapore
| | - Uei Pua
- Department of Diagnostic Radiology, Tan Tock Seng Hospital, 11 Jln Tan Tock Seng, Singapore, 308433, Singapore
| | - Hlaing Hlaing Win
- Department of Vascular and Interventional Radiology, Division of Radiological Sciences, Singapore General Hospital, Radiological Sciences Academic Clinical Programme, Singhealth-Duke-NUS Academic Medical Centre, Outram Road, Singapore, 169608, Singapore
| | - Sivanathan Chandramohan
- Department of Vascular and Interventional Radiology, Division of Radiological Sciences, Singapore General Hospital, Radiological Sciences Academic Clinical Programme, Singhealth-Duke-NUS Academic Medical Centre, Outram Road, Singapore, 169608, Singapore
| | - Nanda Venkatanarasimha
- Department of Vascular and Interventional Radiology, Division of Radiological Sciences, Singapore General Hospital, Radiological Sciences Academic Clinical Programme, Singhealth-Duke-NUS Academic Medical Centre, Outram Road, Singapore, 169608, Singapore
| | - Jasmine M E Chua
- Department of Vascular and Interventional Radiology, Division of Radiological Sciences, Singapore General Hospital, Radiological Sciences Academic Clinical Programme, Singhealth-Duke-NUS Academic Medical Centre, Outram Road, Singapore, 169608, Singapore
| | - Glenn Wei Leong Tan
- Department of General Surgery, Tan Tock Seng Hospital, 11 Jln Tan Tock Seng, Singapore, 308433, Singapore
| | - Farah G Irani
- Department of Vascular and Interventional Radiology, Division of Radiological Sciences, Singapore General Hospital, Radiological Sciences Academic Clinical Programme, Singhealth-Duke-NUS Academic Medical Centre, Outram Road, Singapore, 169608, Singapore
| | - Sum Leong
- Department of Vascular and Interventional Radiology, Division of Radiological Sciences, Singapore General Hospital, Radiological Sciences Academic Clinical Programme, Singhealth-Duke-NUS Academic Medical Centre, Outram Road, Singapore, 169608, Singapore
| | - Kiang Hiong Tay
- Department of Vascular and Interventional Radiology, Division of Radiological Sciences, Singapore General Hospital, Radiological Sciences Academic Clinical Programme, Singhealth-Duke-NUS Academic Medical Centre, Outram Road, Singapore, 169608, Singapore
| | - Tze Tec Chong
- Department of Vascular Surgery, Division of Surgery and Surgical Oncology, Singapore General Hospital, Outram Road, Singapore, 169608, Singapore
| | - Bien Soo Tan
- Department of Vascular and Interventional Radiology, Division of Radiological Sciences, Singapore General Hospital, Radiological Sciences Academic Clinical Programme, Singhealth-Duke-NUS Academic Medical Centre, Outram Road, Singapore, 169608, Singapore
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Changal K, Patel M, Devarasetty PP, Royfman R, Veria S, Vyas R, Mhanna M, Patel N, Beran A, Burket M, Gupta R. Drug-Eluting Stents Versus Conventional Endovascular Therapies in Symptomatic Infrapopliteal Peripheral Artery Disease: A Meta-analysis. JOURNAL OF THE SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY & INTERVENTIONS 2022; 1:100024. [PMID: 39132565 PMCID: PMC11308017 DOI: 10.1016/j.jscai.2022.100024] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Subscribe] [Scholar Register] [Received: 12/17/2021] [Revised: 01/21/2022] [Accepted: 01/26/2022] [Indexed: 08/13/2024]
Abstract
Background Balloon angioplasty is the standard endovascular treatment for symptomatic infrapopliteal peripheral artery disease (PAD). However, recent trials have studied the effectiveness of drug-eluting stents (DES) for infrapopliteal PAD. Objective This study investigated the use of DES compared with standard endovascular techniques for treatment of infrapopliteal artery disease. Methods This is a comprehensive systematic review and meta-analysis of 9 recent randomized controlled trials. The primary clinical outcome assessed was primary patency. The secondary outcomes were target lesion revascularization (TLR), major limb amputation, and all-cause mortality. Results A total of 945 patients met the inclusion criteria. Patients treated with DES were found to have increased primary patency than control at maximum follow-up (hazard ratio [HR] 2.17, 95% confidence interval [CI] 1.58-2.97, P < .0001, I2 = 62%). A similar result was seen in the subgroup of patients with critical limb ischemia (HR 2.58, 95% CI 1.49-4.49, P = .0008, I2 = 75%). DES were associated with significantly lower rates of TLR than control at maximum follow-up (HR 0.48, 95% CI 0.33-0.68, P < .0001; I2 = 11%). There was no statistical difference between DES versus control in rates of major limb amputation and mortality. Conclusions DES have superior primary patency and TLR rates with no difference in amputation and all-cause mortality rates compared with conventional endovascular therapies in patients with infrapopliteal PAD.
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Affiliation(s)
- Khalid Changal
- Cardiovascular Medicine, University of Toledo College of Medicine and Health Sciences, Toledo, Ohio
| | - Mitra Patel
- Department of Medicine, University of Toledo College of Medicine and Health Sciences, Toledo, Ohio
| | | | - Rachel Royfman
- University of Toledo College of Medicine and Health Sciences, Toledo, Ohio
| | - Spiro Veria
- University of Toledo College of Medicine and Health Sciences, Toledo, Ohio
| | - Rohit Vyas
- Cardiovascular Medicine, University of Toledo College of Medicine and Health Sciences, Toledo, Ohio
| | - Mohammed Mhanna
- Department of Medicine, University of Toledo College of Medicine and Health Sciences, Toledo, Ohio
| | - Neha Patel
- Department of Medicine, University of Toledo College of Medicine and Health Sciences, Toledo, Ohio
| | - Azizullah Beran
- Department of Medicine, University of Toledo College of Medicine and Health Sciences, Toledo, Ohio
| | - Mark Burket
- Cardiovascular Medicine, University of Toledo College of Medicine and Health Sciences, Toledo, Ohio
| | - Rajesh Gupta
- Cardiovascular Medicine, University of Toledo College of Medicine and Health Sciences, Toledo, Ohio
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Singh N, Ding L, Magee GA, Shavelle DM. Contemporary treatment of below‐the‐knee peripheral arterial disease in patients with chronic limb threatening ischemia: Observations from the Vascular Quality Initiative. Catheter Cardiovasc Interv 2022; 99:1289-1299. [PMID: 35066986 DOI: 10.1002/ccd.30063] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/06/2021] [Revised: 11/27/2021] [Accepted: 12/26/2021] [Indexed: 11/11/2022]
Affiliation(s)
- Nikhil Singh
- Section of Cardiology, Department of Medicine University of Chicago Chicago Illinois USA
| | - Li Ding
- Department of Population and Public Health Sciences University of Southern California Keck School of Medicine Los Angeles California USA
| | - Gregory A. Magee
- Division of Vascular Surgery and Endovascular Therapy University of Southern California Keck School of Medicine Los Angeles California USA
| | - David M. Shavelle
- MemorialCare Heart and Vascular Institute Long Beach Memorial Medical Center Long Beach California USA
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Feshchenko DA, Zasypkin GS, Rudenko BA, Vasiliev DK, Shukurov FB, Shanoyan АS, Drapkina OM. Reconstruction of infrarenal abdominal aortic occlusion using the Culotte stenting technique: a case report. КАРДИОВАСКУЛЯРНАЯ ТЕРАПИЯ И ПРОФИЛАКТИКА 2022. [DOI: 10.15829/1728-8800-2021-3086] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/24/2022] Open
Abstract
Patients with clinically significant infrarenal abdominal aortic atherosclerosis are often encountered in the clinical practice of vascular and endovascular surgeons. In the absence of timely treatment, the ability to work and life quality of patients are sharply reduced, and in some cases, patients require limb amputation. Until recently, the only treatment option for such a lesion was an open surgery. However, a good skill level of endovascular surgeons and the device availability allow today to perform minimally invasive operations with comparable effectiveness and greater safety in comparison with open surgery. We present a case report of successful endovascular treatment of aortic occlusion involving the right and left common and external iliac arteries using Culotte stenting technique with further 12-month follow-up.
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Affiliation(s)
- D. A. Feshchenko
- National Medical Research Center for Therapy and Preventive Medicine
| | - G. S. Zasypkin
- National Medical Research Center for Therapy and Preventive Medicine
| | - B. A. Rudenko
- National Medical Research Center for Therapy and Preventive Medicine
| | - D. K. Vasiliev
- National Medical Research Center for Therapy and Preventive Medicine
| | - F. B. Shukurov
- National Medical Research Center for Therapy and Preventive Medicine
| | - А. S. Shanoyan
- National Medical Research Center for Therapy and Preventive Medicine
| | - O. M. Drapkina
- National Medical Research Center for Therapy and Preventive Medicine
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50
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Liang P, Wu W, Schermerhorn ML. Tibial Interventions for Peripheral Arterial Disease. COMPLICATIONS IN ENDOVASCULAR SURGERY 2022:229-236. [DOI: 10.1016/b978-0-323-55448-0.00035-8] [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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