Aortic & peripheral vascular diseaseSecondary analysis
2-Year Patient-Centered and Clinical Outcomes of Sirolimus- Versus Paclitaxel-Coated Balloon Angioplasty in Femoropopliteal Artery Disease
- Secondary analysis of the SIRONA randomised trial
- prospective
- multicentre
- noninferiority
- prespecified 2-year outcomes
- Longer-term follow-up ongoing up to 5 years
Authors' conclusion
SCB angioplasty resulted in sustained patient-reported and clinical outcomes comparable to PCB angioplasty through 2 years, with similar patency, revascularization, and safety.
Study context
- Population
- Patients with femoropopliteal artery disease (96.5% intermittent claudication)
- 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 result
As reported in the abstract
Vascular quality of life (VascuQol) · 2 years
Improvements sustained through 2 years and similar between groups; between-group difference
0.05 (95% CI −0.15 to 0.24; P = 0.63)
Further findings
Clinical improvement (≥1 Rutherford category) · 2 years
P = 0.89
Primary patency (Kaplan-Meier) · 2 years
log-rank P = 0.34
Freedom from clinically driven target lesion revascularization · 2 years
log-rank P = 0.42
All-cause mortality · 2 years
- All-cause mortality, in the order SCB and PCB respectively (P = 0.21); no device- or procedure-related deaths
- 6.3% and 3.7%
Safety
Major amputation · 2 years
Original publication
2-Year Patient-Centered and Clinical Outcomes of Sirolimus- Versus Paclitaxel-Coated Balloon Angioplasty in Femoropopliteal Artery Disease. JACC Cardiovasc Interv. Published 24 August 2026. doi:10.1016/j.jcin.2026.06.021
Summarised from the published abstract; every number is checked against it