Sirolimus-Coated Balloon Angioplasty for Infrainguinal Artery Disease

Sirolimus-Coated Balloon Angioplasty for Infrainguinal Artery Disease Published March 30, 2026 N Engl J Med 2026;395:561-570 DOI: 10.1056/NEJMoa2600360 Abstract 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<0.001 for noninferiority; P=0.009 for superiority); a key secondary-outcome event occurred in 144 patients (23.0%) and 193 patients (30.8%), respectively (risk difference, −7.8 percentage points; 95% CI, −12.7 to −2.9; P=0.002). Death occurred in 74 patients (11.8%) in the sirolimus-coated–balloon group and in 80 patients (12.8%) in the uncoated-balloon group (risk difference, −1.0 percentage points; 95% CI, −4.6 to 2.7; P=0.67). The incidence of adverse events appeared to be similar in the two groups. Conclusions Among patients with infrainguinal artery disease undergoing endovascular treatment, angioplasty with sirolimus-coated balloons led to a lower incidence of major adverse limb events at 1 year than angioplasty with uncoated balloons. (Funded by Concept Medical and others; SirPAD ClinicalTrials.gov number, NCT04238546.) Are you a member of an institution such as a university or hospital?Learn more about Institutional Access Notes This article was published on March 30, 2026, at NEJM.org. A data sharing statement provided by the authors is available with the full text of this article at NEJM.org. Supported by an unrestricted grant from Concept Medical (the manufacturer of the MagicTouch PTA sirolimus-coated balloon) and by the University Hospital Zurich and the University of Zurich. Disclosure forms provided by the authors are available with the full text of this article at NEJM.org. We thank all the patients for participating in the SirPAD trial; the staff of all referring centers for their support; Ms. Eliane Probst, Dr. Rebecca Spescha, Ms. Michelle Sonderer, Ms. Désirée Ackermann, Ms. Sandrine Foucras, Ms. Franziska Peier, and Ms. Martine Rime for trial coordination; and the members of the independent data and safety monitoring board for their advice. Supplementary Material Information & Authors Information Published In Copyright Copyright © 2026 Massachusetts Medical Society. All rights reserved. For personal use only. Any commercial reuse of NEJM Group content requires permission. History Published online: March 30, 2026 Published in issue: August 6, 2026 Topics Authors Metrics & Citations Metrics Altmetrics Citations Export citation Select the format you want to export the citation of this publication. Cited by - Sirolimus-Eluting Technology for the Treatment of Peripheral Artery Disease, New England Journal of Medicine, 395, 6, (603-605), (2026)./doi/full/10.1056/NEJMe2602625 Loading...