SIRONA Three-Year Data Shows Reduced Revascularization Rates with Sirolimus-Coated Balloon
Late-breaking results from the SIRONA trial suggest that sirolimus-coated balloons outperform paclitaxel-coated devices in preventing repeat procedures for femoropopliteal disease over three years.
Three-year findings from the SIRONA trial, presented at TCT 2026 and published in JACC: Cardiovascular Interventions, indicate that patients treated with the MagicTouch PTA sirolimus-coated balloon (SCB) required fewer repeat revascularizations than those treated with paclitaxel-coated balloons (PCB). The study, which involved 482 participants with symptomatic femoropopliteal disease, is the first randomized comparison to provide data beyond two years.
At the three-year mark, the rate of freedom from clinically driven target lesion revascularization was 88.2% in the SCB group, compared with 80.2% in the PCB cohort. While the results suggest a clinical advantage for the sirolimus-based technology, researchers noted that there were no significant differences between the groups regarding walking capacity, quality of life, or safety outcomes such as all-cause mortality.
The trial arrives as the medical community re-evaluates the long-term use of paclitaxel-coated devices. Because the SIRONA trial was originally powered for 12-month primary endpoints, the three-year data are considered exploratory. The investigators plan to continue tracking patient outcomes until the five-year follow-up to confirm the durability of these initial findings.