Three-year results from SIRONA found higher freedom from clinically driven target-lesion revascularization with sirolimus-coated balloons than with paclitaxel balloons in patients treated for femoropopliteal disease.
Freedom from clinically driven target-lesion revascularization (cdTLR) was 88.2% in the sirolimus group and 80.2% in the paclitaxel group, an 8-percentage-point difference. The reported hazard ratio was 0.60 (95% confidence interval, 0.36–0.97), with a log-rank P value of 0.03. The findings were presented at TCT 2026 and published in JACC: Cardiovascular Interventions.
SIRONA randomized 482 patients at 25 centers in Germany and Austria after successful predilation of a symptomatic femoropopliteal lesion. Participants received either a sirolimus-coated balloon or a paclitaxel-coated balloon. The original 12-month SIRONA paper reported that 96.3% of participants had intermittent claudication.
The three-year paper reported that pain-free and maximum walking distance, along with quality-of-life scores, improved in both groups, with no difference between them. Concept Medical Inc.’s announcement reported all-cause mortality at 7.4% in each group, with one major amputation in the sirolimus group and two in the paclitaxel group. It also reported no significant difference in freedom from clinically driven target-vessel revascularization, at 83.8% versus 79.1%.
Investigators described the three-year results as exploratory because the trial’s primary endpoints were set at 12 months. The initial report found that sirolimus met the noninferiority test for primary patency, but sensitivity analyses did not establish that result as statistically robust. SIRONA compared two coated balloons and had no uncoated-device group.
Concept Medical Inc. said it funded the trial but did not participate in analyzing or interpreting the data or preparing the manuscript. The company said follow-up will continue through five years. Prof. Ulf Teichgräber, SIRONA’s principal investigator, said in the company’s announcement, “Five-year follow-up will tell us whether this benefit holds.”
