3-Year Results Following Femoropopliteal Lesion Treatment With a Novel Sirolimus-Eluting Balloon

BACKGROUND: Sirolimus drug-eluting balloons (DEB) are an emerging technology for the treatment of femoropopliteal (FP) lesions, but data beyond 1 year are limited. OBJECTIVES: The authors sought to evaluate the longer-term safety and efficacy of the SELUTION SLR DEB for treatment of FP disease in a Japanese population. The trial was registered with the Japan Registry of Clinical Trials (Clinical Study of MDK-1901 for Patients with Superficial Femoral and Popliteal Artery Lesions [SELUTION SFA JAPAN]; jRCT1080225338). METHODS: The SELUTION SFA JAPAN study is a multicenter, prospective, single-arm study. It was independently adjudicated by an imaging core laboratory and clinical events committee. Endpoints through 36 months included primary patency, target lesion revascularization, and major adverse events. RESULTS: A total of 134 patients were enrolled; the median follow-up was 1,089 days (Q1-Q3: 1,071-1,102 days). The mean age was 73.8 ± 6.9 years, and 60.3% of patients had diabetes mellitus. The median lesion length was 129.6 (Q1-Q3: 77.9-184.9) mm; 17.2% (23/134) were chronic total occlusions and 26.9%(36/134) were moderately to severely calcified; 1.5% (2/134) were stented during the index procedure. The 36-month primary patency rate was 81.5% (95% CI: 73.7%-87.2%) and the freedom from clinically driven target lesion revascularization (TLR) was 93.8% (95% CI: 88.0%-96.9%). The major adverse event rate was 14.2%, composed of 8 clinically driven TLRs and 11 all-cause deaths; none were related to the device or procedure. Improvements in ankle-brachial index and Rutherford class were marked and sustained through 36 months. CONCLUSIONS: Three-year results from the SELUTION SFA JAPAN study demonstrated durability of the SELUTION DEB and confirmed it is a safe and effective treatment option for FP disease in symptomatic patients.