Aortic & peripheral vascular diseaseRandomised controlled trial
Sirolimus-Coated Balloon Angioplasty for Infrainguinal Artery Disease
- Randomised controlled trial
- open-label
- noninferiority
- prespecified sequential testing for superiority
- blinded outcome adjudication
Authors' conclusion
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.
Study context
- Population
- Patients with infrainguinal artery disease undergoing endovascular treatment
- Participants
- 1,252 patients
- Comparison
- Sirolimus-coated balloon vs uncoated balloon angioplasty
- Sirolimus-coated balloonn = 626
- Uncoated balloonn = 626reference
- Primary endpoint
- Unplanned major amputation of the target limb or endovascular/surgical revascularization of the target lesion for critical limb ischemia
- Follow-up
- 1 year after randomization
Primary result
As reported in the abstract
Median unbiased estimate of risk difference
−4.9 percentage points
95% CI −8.5 to −1.3
P < 0.001 for noninferiority; P = 0.009 for superiority
Events by treatment group
Sirolimus-coated balloon vs Uncoated balloon
median unbiased estimate of risk difference −4.9 percentage points (95% CI −8.5 to −1.3); P < 0.001 for noninferiority; P = 0.009 for superiority
Secondary outcomes
| Outcome | Sirolimus-coated balloon | Uncoated balloon | risk difference (percentage points) (95% CI) | P value | |
|---|---|---|---|---|---|
| Key secondary: any unplanned amputation of target limb or target-lesion revascularization for critical or noncritical limb ischemia · 1 year | 23.0% | 30.8% | −7.8 (−12.7 to −2.9) | P = 0.002 | |
| All-cause death (primary safety outcome) · 1 year | 11.8% | 12.8% | −1.0 (−4.6 to 2.7) | P = 0.67 | |
| −20−10010Difference, percentage points (linear scale) |
Safety
Adverse events
- Incidence appeared similar in the two groups
Original publication
Sirolimus-Coated Balloon Angioplasty for Infrainguinal Artery Disease. N Engl J Med. Published 30 March 2026. doi:10.1056/nejmoa2600360
Summarised from the published abstract; every number is checked against it