Sirolimus-Coated Balloon Angioplasty for Infrainguinal Artery Disease
Sirolimus-coated balloon angioplasty reduced major limb events at 1 year versus uncoated balloon angioplasty.
*Randomized noninferiority trial; Level 2 (OCEBM).
Citation
Barco S, Engelberger RP, Held U, et al. Sirolimus-Coated Balloon Angioplasty for Infrainguinal Artery Disease. N Engl J Med. 2026;395:561-570. doi:10.1056/NEJMoa2600360
Background
Peripheral artery disease below the groin can cause pain, poor wound healing, repeat procedures, amputation, and death. Drug-coated balloons aim to keep treated arteries open, but whether sirolimus-coated balloons improve major limb outcomes was uncertain.
Patients
1252 adults with symptomatic infrainguinal artery disease needing endovascular treatment. Exclusions included pregnancy, planned pregnancy, breast-feeding, sirolimus allergy, or recent investigational-trial participation.
Intervention
Angioplasty with a sirolimus-coated balloon after standard predilation.
Control
Angioplasty with an approved uncoated balloon after standard predilation.
Outcome
Primary: unplanned major amputation of the treated limb or repeat treatment of the target lesion for critical limb ischemia. Secondary outcomes included broader amputation or repeat-treatment composites and death.
Follow-up Period
1 year.
Results
| Outcome | Sirolimus-coated balloon | Uncoated balloon | Effect | Number needed to treat |
|---|---|---|---|---|
| Major amputation or repeat treatment for critical ischemia (primary) | 55/626 (8.8%) | 94/626 (15.0%) | Risk difference −4.9 percentage points (95% CI −8.5 to −1.3) | 17 |
| Any amputation or repeat treatment for critical or noncritical ischemia | 144/626 (23.0%) | 193/626 (30.8%) | Risk difference −7.8 percentage points (95% CI −12.7 to −2.9) | 13 |
| Repeat treatment of target lesion for critical or noncritical ischemia | 124/626 (19.8%) | 162/626 (25.9%) | Risk difference −6.1 percentage points (95% CI −10.7 to −1.4) | 17 |
CI = confidence interval.
Results were intention-to-treat. This noninferiority trial used a 5-percentage-point margin and then met superiority criteria. The control was current standard uncoated balloon angioplasty. The primary composite was mainly repeat treatment; major amputation alone was not significantly reduced. Death and serious adverse events were not significantly different.
Limitations
Open-label treatment may have influenced decisions to repeat procedures. Follow-up was limited to 1 year. The trial was not powered for amputation alone. Participants came from one Swiss health system and were predominantly White.
Funding
Concept Medical and Swiss universities; manufacturer cofunding raises potential bias concern.
Clinical Application
Consider sirolimus-coated balloons for symptomatic infrainguinal disease needing angioplasty, while awaiting longer-term safety and broader-population confirmation.
Discussion
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In this open-label randomized noninferiority trial, sirolimus-coated balloon angioplasty vs uncoated balloon reduced 1-year major adverse limb events (8.8% vs 15.0%; risk difference −4.9 percentage points). Given blinded adjudication but unblinded operators, is the result valid and applicable enough to change your endovascular practice? In the trial, the primary outcome occurred in 8.8% of patients treated with sirolimus-coated balloons and 15.0% treated with uncoated balloons. Which statement best describes the absolute treatment effect?