Sirolimus-Coated Balloon Angioplasty for Infrainguinal Artery Disease

BACKGROUND: Whether sirolimus-coated balloon angioplasty for infrainguinal artery disease reduces the incidence of major adverse limb events remains unknown. METHODS: In this prospective, open-label, noninferiority trial with a prespecified sequential testing strategy for superiority and blinded outcome adjudication, we randomly assigned patients with infrainguinal artery disease in a 1:1 ratio to undergo angioplasty with a sirolimus-coated balloon or with an uncoated balloon. The primary outcome was a composite of unplanned major amputation affecting the target limb or endovascular or surgical revascularization of the target lesion for critical limb ischemia within 1 year after randomization. The key secondary outcome was a composite of any unplanned amputation affecting the target limb or revascularization of the target lesion for critical or noncritical limb ischemia within 1 year after randomization. The noninferiority margin was 5 percentage points. The primary safety outcome was death from any cause within 1 year after randomization. RESULTS: A total of 1252 patients were enrolled in the trial: 626 patients were assigned to the sirolimus-coated-balloon group and 626 to the uncoated-balloon group. The median age of the patients was 75 years, and 35.1% were women. A primary-outcome event occurred in 55 patients (8.8%) in the sirolimus-coated-balloon group and in 94 patients (15.0%) in the uncoated-balloon group (median unbiased estimate of risk difference, -4.9 percentage points; 95% confidence interval [CI], -8.5 to -1.3; P