SIRONA: Head-to-Head Comparison of SIROlimus Versus Paclitaxel Drug-Eluting BallooN Angioplasty in the Femoropopliteal Artery, three-year outcomes

doi:10.1016/j.jcin.2026.10.020

SIRONA

Patient / Population Intervention / Exposure Comparison Outcome

In patients with symptomatic femoropopliteal artery disease, sirolimus-coated balloon angioplasty did not improve walking capacity, quality of life or clinical safety at three years compared with a paclitaxel-coated balloon strategy.

N

482patients

Design

Investigator-initiated, multicentre (22 sites in Germany and Austria; Jena University Hospital), open-label randomised trial of sirolimus- versus paclitaxel-coated balloons for femoropopliteal disease, Rutherford 2 to 4; three-year follow-up

Endpoint

Freedom from clinically driven target lesion revascularisation (primary at 12 months); safety. TCT presents three-year outcomes

ResultThree-year freedom from clinically driven target lesion revascularisation was 88.2% (95% CI 83.1%-91.9%) with sirolimus-coated balloons vs 80.2% (95% CI 74.1%-85.0%) with the paclitaxel-coated balloon strategy (HR 0.60, 95% CI 0.36-0.97; nominal log-rank P = 0.03). A post hoc analysis suggested time-varying treatment effects (treatment-by-period interaction P = 0.006), with separation after the first year. Freedom from clinically driven target vessel revascularisation (HR 0.78, 95% CI 0.50-1.21; nominal P = 0.27) and amputation-free survival (HR 1.09, 95% CI 0.57-2.09; nominal P = 0.79) did not differ. Changes in patient-reported walking distance did not differ, and no between-group differences were seen in health-related quality of life or clinical safety outcomes. Three-year follow-up was completed by 76.5% vs 79.6%.

Teichgräber U, Ingwersen M, et al. JACC Cardiovasc Interv. 2026; published online 2 November. 10.1016/j.jcin.2026.10.020

Discussion & critique

Through three years, sirolimus-coated balloons matched the paclitaxel-coated balloon strategy on walking capacity, quality of life and clinical safety, and showed nominally higher freedom from clinically driven target lesion revascularisation. The authors call the three-year analysis exploratory and not adjusted for multiplicity, so the revascularisation difference needs confirmation, and the finding that the curves separated after the first year comes from a post hoc analysis. Three-year follow-up was incomplete at 76.5% and 79.6%, which weakens the time-to-event estimates. The abstract gives no three-year figures for patency, mortality or major amputation, and the comparator was a paclitaxel-coated balloon strategy rather than a single device.