%0 Journal Article
%T A Novel Sirolimus-Coated Balloon for the Treatment of Femoropopliteal Lesions: The SELUTION SFA Japan Trial.
%A Iida O
%A Soga Y
%A Saito S
%A Mano T
%A Hayakawa N
%A Ichihashi S
%A Kawasaki D
%A Suzuki K
%A Yamaoka T
%A Fujihara M
%A Nakama T
%A Nakamura M
%A Horie K
%A Shah T
%A Lansky A
%A Kozuki A
%J JACC Cardiovasc Interv
%V 17
%N 13
%D 2024 Jul 8
%M 38842992
%F 11.075
%R 10.1016/j.jcin.2024.03.029
%X <B>BACKGROUND: </B>Sirolimus-coated balloons (SCB) for the treatment of femoropopliteal (FP) lesions have not been systematically studied, but initial outcomes from early studies are promising.<BR><B>OBJECTIVE: </B>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.<BR><B>METHODS: </B>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.<BR><B>RESULTS: </B>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).<BR><B>CONCLUSIONS: </B>The SELUTION SFA JAPAN trial demonstrated that a novel SELUTION SCB is a safe and effective treatment option for FP disease in symptomatic patients.