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Background: There is a scarcity of published head-to-head comparisons between different paclitaxel-coated angioplasty balloons. More prospective safety data to support the health care economic reimbursement processes are needed., Objectives: The aim of this study was to report the safety and efficacy of the Passeo-18 Lux drug-coated balloon (DCB) (Biotronik AG) for the treatment of symptomatic peripheral artery disease caused by stenosis, restenosis, or occlusion of the femoral and/or popliteal arteries., Methods: A total of 302 patients were randomized 1:1 and assigned to the Passeo-18 Lux DCB (study device) group or the IN.PACT Admiral DCB (control device, Medtronic Vascular) group for testing of noninferiority. The primary efficacy endpoint was freedom from clinically driven target lesion revascularization at 12 months. The primary safety endpoint was a composite of freedom from device-/procedure-related death through 30 days postindex procedure, major target limb amputation, and clinically driven target vessel revascularization at 12 months., Results: At 12 months, 130 of 134 patients in the IN.PACT Admiral group had freedom from clinically driven target lesion revascularization (97.0%) compared with 137 of 141 patients in the Passeo-18 Lux group (97.2%). The primary safety endpoint showed 96.3% in the control group vs 95.7% in the study device group. The null hypothesis of inferiority on both efficacy and safety was rejected. The Kaplan-Meier estimate of primary patency at 1 year was 88.7% in the control arm vs 91.5% in the study device arm., Conclusions: The Passeo-18 Lux and the IN.PACT Admiral DCBs demonstrate comparable results with excellent effectiveness and safety through 12 months for femoropopliteal interventions., Competing Interests: Funding Support and Author Disclosures The study sponsor is ID3 Medical, with funding through a research grant from Biotronik. The funding source was not involved in collecting, monitoring, or analyzing study data. The principal investigator (Dr Deloose) prepared all data presentation and manuscript drafts, which were reviewed by the other authors. Dr Deloose has provided consultancy and has received lecture honoraria from Boston Scientific, Biotronik, Abbott, iVascular, Cook, Gore, Maquet-Getinge, Medtronic, BD Bard, Terumo, and GE Healthcare; and is on the advisory boards for Abbott, Medtronic, Philips, Boston Scientific, Biotronik, and BD Bard. Dr Lansink has provided consultancy for Abbott, Biotronik, Medtronic, Boston Scientific, and BD Bard. Dr Brodmann has provided consultancy for Medtronic, BD Bard, Boston Scientific, Biotronik, Philips, and Shockwave. Dr Gouëffic has received research funding from Abbott, Boston Scientific, Cook, General Electric, Veryan, and WL Gore; and personal fees and grants from Abbott, BD Bard, Biotronik, Boston Scientific, Cook, General Electric, Medtronic, Penumbra, Shockwave, Terumo, Veryan, and WL Gore (medical advisory board, educational course, speaking). Dr Verbist is a consultant for iVascular, Biolitec, and Duomed. Dr Maene is a consultant for Abbott Vascular, iVascular, and Terumo. Dr Brunet is a consultant for Abbott Vascular, Boston Scientific, Philips Igt, Terumo, and Shockwave. Dr Levent is a consultant for Biotronik. Dr Sauguet has received honoraria from Abbott and Medtronic. Dr Callaert has received lecture honoraria from Medtronic, Balt, and Terumo. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Purpose: Although effectiveness and safety of many different paclitaxel coated balloons in the treatment of peripheral arterial disease (PAD) are extensively studied, there is a lack of direct head-to-head comparison studies. To meet this need and to avoid potential "class-effects", the BIOPACT was set up. The purpose is to demonstrate the safety and efficacy of the Passeo-18 Lux DCB (Biotronik) for treatment of patients with symptomatic PAD due to femoropopliteal lesions., Methods: 302 patients are randomized in a 1:1 manner to treatment with either the Passeo-18 Lux DCB or the IN.PACT Admiral DCB (Medtronic) for testing of a formal non-inferiority hypothesis. The participants will be followed for 5 years. The primary efficacy endpoint is freedom from clinically-driven target lesion revascularization (CD-TLR) at 12 months, defined as any re-intervention at the target lesion due to symptoms, drop of ankle brachial index (ABI) > 20% or > 0.15 compared to post-procedural ABI. Primary safety endpoint is a composite of freedom from device/procedure-related death through 30 days post-index procedure, freedom from major target limb amputation and clinically-driven target vessel revascularization (CD-TVR) through 12 months post-index procedure. Secondary endpoints can be found at clinicaltrials.gov, ID NCT03884257., Discussion: As full enrolment was reached by the beginning of September, the investigators expect complete analysis of the primary endpoints by the end of 2022; Meanwhile preliminary results will be disclosed during 2022. As in terms of randomized head-to-head efficacy and safety analysis, this study on paclitaxel coated balloons may provide additional information to clinicians and healthcare providers. Trial registration ClinicalTrials.gov ID: NCT03884257 LEVEL OF EVIDENCE: Level 2, Randomized trial., (© 2022. Springer Science+Business Media, LLC, part of Springer Nature and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE).)

Purpose: Data on the long-term safety and effectiveness of drug-coated balloons (DCBs) for the treatment of long femoropopliteal atherosclerotic lesions in the real-world setting are rare. This study reports 3 year and 5 year outcomes of the pre-specified 150 mm balloon sub-cohort of the IN.PACT Global Study., Methods: The IN.PACT Global Study was a prospective, multicentre, international, single-arm study evaluating the performance of the IN.PACT Admiral DCB in real-world patients with femoropopliteal atherosclerotic disease. This pre-specified 150 mm DCB cohort analysis comprised 107 participants (111 lesions) with all target lesions treated with at least one 150 mm DCB., Results: Mean lesion length was 20.3 ± 9.2 cm; 18.0% had in-stent restenosis, 58.6% were totally occluded, and 17.1% were severely calcified. Through 60 months, the Kaplan-Meier estimate of freedom from clinically driven target lesion revascularization (CD-TLR) was 72.7% [95% confidence interval (CI):62.4%-80.5%]. The safety composite endpoint (freedom from device/procedure-related death through 30 days; freedom from target limb major amputation and clinically driven target vessel revascularization through 5 years) was 70.5%. The cumulative incidence of major amputation was 1.0% and all-cause mortality was 18.4% through 60 months. Freedom from CD-TLR rates in the provisional stented and non-stented subgroups through 36 months were 64.0% [95% CI: 46.1%-77.3%] and 81.9% [95% CI: 69.7%-89.6%] (log-rank p = 0.074), respectively., Conclusions: The results demonstrate sustained long-term safety of the 150 mm IN.PACT Admiral DCB for long femoropopliteal atherosclerotic lesions in real-world patients. In particular, the results show that DCB angioplasty is an effective revascularization modality in long complex lesions., Clinicaltrials: gov identifier: NCT01609296., Level of Evidence: Level 3, Cohort Study., (© 2022. The Author(s).)

Background: This clinical trial aims to evaluate the outcome (up to 24-months) of the treatment of in-stent restenotic or reoccluded lesions in the femoropopliteal arteries, by comparing the treatment of the GORE ® VIABAHN ® Endoprosthesis with PROPATEN Bioactive Surface (W. L. Gore & Associates, Flagstaff, AZ, USA) with a standard PTA treatment. The primary effectiveness endpoint of the study is the primary patency at 12 months, defined as no evidence of restenosis or occlusion within the originally treated lesion based on color-flow duplex ultrasound (PSVR≤2.5) and without target lesion revascularization (TLR) within 12 months. The primary safety endpoint is the proportion of subjects who experience serious device-related adverse events within 30 days postprocedure., Methods: A total of 83 patients meeting inclusion and exclusion criteria have been enrolled in this prospective, randomized, multicenter, controlled study in 7 sites between June 2010 and February 2012. Patients with an in-stent restenosis lesion in the femoropopliteal region and a Rutherford classification from 2 to 5 could be enrolled. After screening, the patient was randomized to either treatment with the GORE ® VIABAHN ® Endoprosthesis with PROPATEN Bioactive Surface or treatment with a standard PTA balloon. After the index procedure, follow-up visits at 1 month, 6 months, 12 months and 24 months were required. A color flow Doppler ultrasound was performed on all follow-up visits and a quantitative vascular angiography at the 12-month follow-up visit., Results: In the VIABAHN ® group, 39 patients (74.4% male; mean age 67.69±9.77 years) were enrolled and in the PTA group, 44 patients (72.7% male; mean age 68.98±9.71 years) were enrolled, which is comparable for both treatment groups. In the VIABAHN ® group, 34 (87.2%) patients presented with claudication (Rutherford 2 and 3) and 5 (12.8%) patients had critical limb ischemia (Rutherford 4 and 5). In the PTA group, 36 (81.8%) patients were claudicants (Rutherford 2 and 3) and 8 (18.2%) presented with critical limb ischemia (Rutherford 4 and 5). The 12-month primary patency rates were 74.8% for the VIABAHN ® group and 28.0% for the PTA group (P<0.001). No patients were reported to have device-related serious adverse events within 30 days postprocedure. The primary patency rate for the 24-month follow-up was 58.40% in the Viabahn group and 11.60% in the PTA group (P<0.001)., Conclusions: The treatment of femoropopliteal in-stent restenosis with a VIABAHN ® Endoprosthesis shows significantly better results than the treatment with a standard PTA balloon. This demonstrates that the use of the VIABAHN ® Endoprosthesis is a very promising tool for the treatment of complex in-stent restenosis.

Non-maturation of arteriovenous fistulas is a frequent problem after dialysis access creation, especially in the forearm. The presence of accessory veins may play an important role in the non-maturing fistula. Several surgical and endovascular techniques are described to deal with this problem. We describe a new surgical technique in which we perform a rejoining of the arm veins to create a single large run-off vessel with greater diameter and flow for haemodialysis.

Objectives: This is the first-in-human study of a drug-eluting bioresorbable vascular scaffold (BVS) for treatment of peripheral artery disease (PAD) involving the external iliac artery (EIA) and superficial femoral artery (SFA)., Background: Drug-eluting BVS has shown promise in coronary arteries., Methods: The ESPRIT BVS system is a device-drug combination consisting of an everolimus-eluting poly-l-lactide scaffold. Safety and performance were evaluated in 35 subjects with symptomatic claudication., Results: Lesions were located in the SFA (88.6%) and EIA (11.4%). Mean lesion length was 35.7 ± 16.0 mm. The study device was successfully deployed in 100% of cases, without recoil. Procedure-related minor complications were observed in 3 patients (groin hematoma, dissection). Within 2 years there was 1 unrelated death, but no patients in this cohort had an amputation. At 1 and 2 years, the binary restenosis rates were 12.1% and 16.1%, respectively, and target lesion revascularization was performed in 3 of 34 patients (8.8%) and 4 of 32 patients (11.8%), respectively. The ankle brachial index 0.75 ± 0.14 improved from pre-procedure to 0.96 ± 0.16 at 2 years' follow-up. At 2 years, 71.0% of the patients were Rutherford-Becker 0, and 93.5% achieved a maximum walking distance of 1,500 feet., Conclusions: The safety of the ESPRIT BVS was demonstrated with no procedure or device-related deaths or amputations within 2 years. The low occurrence of revascularizations was consistent with duplex-ultrasonography showing sustained patency at 2-years. (A Clinical Evaluation of the Abbott Vascular ESPRIT BVS [Bioresorbable Vascular Scaffold] System [ESPRIT I]; NCT01468974)., (Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Purpose: To evaluate the short- and midterm outcomes of the Viabahn endoprosthesis with Propaten Bioactive Surface vs. standard balloon angioplasty for treatment of in-stent restenosis in the superficial femoral artery., Methods: Between June 2010 and February 2012, 83 patients with superficial femoral artery in-stent and Rutherford category 2 to 5 ischemia were enrolled at 7 sites participating in this prospective randomized controlled study (RELINE; ClinicalTrials.gov; identifier NCT01108861). The patients were randomized to treatment with either the heparin-bonded Viabahn endoprosthesis (n = 39: 29 men; mean age 67.7 ± 9.8 years) or a standard angioplasty balloon (n = 44: 32 men; mean age 69.0 ± 9.7 years). The primary effectiveness outcome was primary patency at 12 months, defined as no restenosis/occlusion within the target lesion based on duplex ultrasound and no target lesion revascularization. The primary safety endpoint was the incidence of serious device-related adverse events within 30 days of the procedure., Results: All patients randomized to receive dilation or the Viabahn stent-graft were treated according to their assignment. The technical success was 100% for the Viabahn group and 81.8% for the angioplasty group (p = 0.002) owing to 9 patients requiring a bailout procedure after unsuccessful angioplasty. The 12-month primary patency rates were 74.8% for the Viabahn group and 28.0% for the angioplasty group (p < 0.001). Excluding the 9 angioplasty patients who received bailout stenting, the primary patency for optimal balloon angioplasty was 37.0% (p < 0.001). Three patients experienced device-related adverse events within 30 days: occlusion of the target lesion (Viabahn group), peripheral embolization (angioplasty group), and reocclusion of the target lesion (angioplasty group)., Conclusion: In this study, the treatment of femoropopliteal in-stent restenosis with a Viabahn endoprosthesis showed significantly better results than treatment with a standard balloon at 1 year., (© The Author(s) 2015.)

The BRAVISSIMO study is a prospective, non-randomized, multi-center, multi-national, monitored trial, conducted at 12 hospitals in Belgium and 11 hospitals in Italy. This manuscript reports the findings up to the 12-month follow-up time point for both the TASC A&B cohort and the TASC C&D cohort. The primary endpoint of the study is primary patency at 12 months, defined as a target lesion without a hemodynamically significant stenosis on Duplex ultrasound (>50%, systolic velocity ratio no greater than 2.0) and without target lesion revascularization (TLR) within 12 months. Between July 2009 and September 2010, 190 patients with TASC A or TASC B aortoiliac lesions and 135 patients with TASC C or TASC D aortoiliac lesions were included. The demographic data were comparable for the TASC A/B cohort and the TASC C/D cohort. The number of claudicants was significantly higher in the TASC A/B cohort, The TASC C/D cohort contains more CLI patients. The primary patency rate for the total patient population was 93.1%. The primary patency rates at 12 months for the TASC A, B, C and D lesions were 94.0%, 96.5%, 91.3% and 90.2% respectively. No statistical significant difference was shown when comparing these groups. Our findings confirm that endovascular therapy, and more specifically primary stenting, is the preferred treatment for patients with TASC A, B, C and D aortoiliac lesions. We notice similar endovascular results compared to surgery, however without the invasive character of surgery.

Objective: Several prosthetic materials have been used for femoropopliteal bypass grafting in patients with peripheral vascular disease in whom a venous bypass is not possible. Expanded polytetrafluoroethylene (ePTFE) is the most commonly used, but patency results have not always equaled those achieved with vein, especially in below-knee reconstructions. This study assessed the performance of a new heparin-bonded ePTFE vascular graft that was designed to provide resistance to thrombosis and thereby decrease early graft failures and possibly prolong patency., Method: From June 2002 to June 2003, 86 patients (62 men and 24 women; mean age, 70 years; 99 diseased limbs) were enrolled prospectively in a nonrandomized, multicenter study of the heparin-bonded ePTFE graft. Fifty-five above-knee and 44 below-knee (including 21 femorocrural) procedures were performed. Follow-up evaluations consisted of clinical examinations, ultrasonographic studies, and distal pulse assessments. Patency and limb salvage rates were assessed by using life-table analyses., Results: All grafts were patent immediately after implantation. There were no graft infections or episodes of prolonged anastomotic bleeding. During the 1-year follow-up, 10 patients died, 15 grafts occluded, and 5 major amputations were performed. The overall primary and secondary 1-year patency rates were 82% and 97%, respectively. The limb salvage rate in patients with critical limb ischemia (n = 41) was 87%. Primary patency rates according to bypass type were 84%, 81%, and 74% for above-knee femoropopliteal, below-knee femoropopliteal, and femorocrural bypasses, respectively; the corresponding secondary patency rates were 96%, 100%, and 100%., Conclusions: In this study, the heparin-bonded ePTFE graft provided promising early patency and limb salvage results, with no device-related complications, in patients with occlusive vascular disease. Longer-term and randomized studies are warranted to determine whether this graft provides results superior to those achieved with other prostheses, especially in patients at increased risk of early graft failure, such as those undergoing below-knee bypass and those with poor run-off or advanced vascular disease.