A Novel Sirolimus-Coated Balloon for the Treatment of Femoropopliteal Lesions: The SELUTION SFA Japan Trial.

Background: Sirolimus-coated balloons (SCB) for the treatment of femoropopliteal (FP) lesions have not been systematically studied, but initial outcomes from early studies are promising.
Objectives: The authors sought to evaluate the safety and efficacy of the SELUTION SLR SCB, composed of proprietary microreservoir technology combining sirolimus and biodegradable polymer, when used to treat mild-to-moderate FP disease in a Japanese population.
Methods: This multicenter, prospective, single-arm study (SELUTION SFA JAPAN) enrolled 134 patients with FP disease. It was independently adjudicated by an imaging core laboratory and clinical events committee. The primary endpoint was 12-month primary patency, defined as peak systolic velocity ratio ≥2.5 by duplex ultrasound and compared against a prespecified performance goal of 60% based on established angioplasty data.
Results: The mean age was 73.8 ± 6.9 years, and 60.3% of patients had diabetes mellitus. The mean lesion length was 127.4 ± 59.7 mm, 17.2% were chronic total occlusions, and 47.8% involved the popliteal artery. Data on 12-month restenosis were available in 127 patients (94.8%). The 12-month primary patency rate was 87.9%, and the freedom from clinically driven target lesion revascularization (CD-TLR) was 97.0% per Kaplan-Meier estimate. The major adverse event rate was 6.7%, driven by 4 CD-TLRs and 5 deaths, none of which were related to the device or procedure. Ankle-brachial index data improved significantly from 0.73 ± 0.16 at baseline to 0.96 ± 0.14 at 30 days postprocedure and was sustained through 12 months (0.94 ± 0.13).
Conclusions: The SELUTION SFA JAPAN trial demonstrated that a novel SELUTION SCB is a safe and effective treatment option for FP disease in symptomatic patients.
Competing Interests: Funding Support and Author Disclosures This study was sponsored by MedAlliance Japan K.K. Dr Iida has served on advisory boards for Boston Scientific and Cordis; is a consultant for Boston Scientific, Otsuka Medical Devices, and Nipro; and has received honoraria from Boston Scientific, Becton Dickinson, Cordis, W.L. Gore, Medtronic, Terumo, and Kaneka Medix. Dr Soga has received honoraria from Boston Scientific, Cordis, Kaneka Medix, Medtronic, and Terumo. Dr Mano has received research support from Abbott Vascular. Dr Hayakawa has received honoraria from Terumo, Kaneka Medix, Medicos Hirata, Boston Scientific, Medtronic, and Becton Dickinson. Dr Ichihashi has received honoraria from Boston Scientific, Becton Dickinson, Cordis, W.L. Gore, Medtronic, and Terumo. Dr Kawasaki is a consultant for Cordis and Nipro. Dr Yamaoaka is a consultant for Japan Lifeline; and has received honoraria from W.L. Gore, Boston Scientific, and Kaneka Medix. Dr Nakama is on Asahi Intecc’s advisory board; is a consultant for Becton Dickinson, Boston Scientific, Cook Medical, Century Medical. Cordis, Nipro, and Orbus Neich; and has received honoraria from Abbott Vascular, Kaneka Medix, Medtronic, and Terumo. Dr Fujihara is a consultant for Century Medical, Nipro, Terumo, and Cordis; and has received honoraria from Boston Scientific, Medtronic, W.L. Gore, and Terumo. Dr Nakamura has received endowed department from Boston Scientific Japan, Kaneka, Terumo, Nipro, Otsuka Medical, Japan Lifeline, Asahi Intecc, and Biotronik Japan. Dr Lansky is on the advisory boards and has received honoraria from Cordis, Abiomed, Sinomed, Microport, and Boston Scientific; and has received institutional research support from Bard, Silkroad Medical, Abbott Vascular, Emboline, and Filterlex. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
(Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)