SirPAD
Sirolimus-Coated Balloon vs Uncoated Balloon Angioplasty for Peripheral Arterial Disease
Presented by Stefano Barco — University Hospital Zurich
Subspecialty: Interventional
Published in NEJM
Key Result
Results from the world's largest sirolimus-coated balloon trial in peripheral artery disease (N>1,250) were presented at ACC.26 and published in NEJM.
What did this trial find?
SirPAD is the world's largest randomized controlled trial (N>1,250) comparing sirolimus-coated balloon angioplasty (MagicTouch PTA) versus standard uncoated balloon angioplasty in patients with femoro-popliteal and below-the-knee peripheral arterial disease, with 12-month major adverse limb events (MALE) as the primary endpoint. Results were presented at ACC.26 and published in NEJM. The source material available is primarily from the enrollment completion announcement (January 2025), with quotes from the principal investigators and the device manufacturer; no editorials, outside commentary, or reaction to the actual results were found in the provided sources.
Why does this trial matter?
Mostly straightforward coverage. The source material contains only pre-results enrollment completion press releases and protocol publications. No editorials, independent expert reactions, or commentary on the actual trial results (which were presented at ACC.26 and published in NEJM) were found. The only quotes available are from the trial's own principal investigators and the device manufacturer, all from January 2025 — well before results were announced. There is no meaningful interpretation debate or controversy captured in these sources.
Study Design
Investigator-initiated, multicenter, open-label, phase III randomized controlled trial
Clinical Implications
Addresses the critical need for robust clinical outcome data on sirolimus-coated balloons as alternatives to paclitaxel-coated devices in PAD, given prior safety concerns with paclitaxel.
Abstract
SirPAD is the world's largest randomized controlled trial of sirolimus-coated balloons for peripheral artery disease. Led by Nils Kucher and Stefano Barco from University Hospital Zurich, the trial enrolled over 1,250 patients with femoro-popliteal and below-the-knee PAD, comparing the MagicTouch PTA sirolimus-coated balloon against standard uncoated balloon angioplasty. The primary efficacy endpoint was major adverse limb events (MALE) at 12 months, including unplanned major amputation and target lesion revascularization for critical limb ischemia.