Aortic & peripheral vascular diseaseRandomised controlled trial
Comparison of Sirolimus- vs Paclitaxel-Coated Balloon Angioplasty for Femoropopliteal Artery Disease
- Randomised controlled trial
- multicentre
- non-inferiority
- masked participants and outcome assessors
- 25 centres in Germany and Austria
Authors' conclusion
Among patients with femoropopliteal artery disease, SCBs demonstrated noninferior clinical important outcomes and comparable improvement in vascular quality of life compared with PCBs.
Study context
- Population
- Patients ≥18 years with symptomatic femoropopliteal artery disease and a single target lesion
- Participants
- 482 patients
- Comparison
- Sirolimus-coated balloon vs paclitaxel-coated balloon angioplasty
- Sirolimus-coated balloon (SCB)n = 238
- Paclitaxel-coated balloon (PCB)n = 244reference
- Primary endpoint
- Primary patency; and composite clinical endpoint of freedom from clinically driven target vessel revascularization, major target limb amputation, and device- or procedure-related death
- Follow-up
- 12 months
Primary result
As reported in the abstract
SCB
150 of 203 (73.9%)
Primary patency · Primary clinical endpoint 199 of 220 (90.5%)
PCB
149 of 199 (74.9%)
Primary patency · Primary clinical endpoint 202 of 218 (92.7%)
SCB vs PCBRisk difference (95% CI)P value
primary patency; noninferiority not statistically robust in sensitivity analyses
−1.0%(−9.6% to 7.6%)
P = 0.019for non-inferiorityprimary clinical endpoint; confirmed by sensitivity analyses
−2.2%(−7.7% to 3.2%)
P = 0.003for non-inferiorityOriginal publication
Comparison of Sirolimus- vs Paclitaxel-Coated Balloon Angioplasty for Femoropopliteal Artery Disease. J Am Coll Cardiol. Published 18 February 2026. doi:10.1016/j.jacc.2025.12.017
Summarised from the published abstract; every number is checked against it