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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.)

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.)