Three-year SIRONA trial data shows benefit of sirolimus-coated balloon in arterial disease
Results from the SIRONA study indicate that sirolimus-coated balloons reduce the need for repeat revascularization compared to paclitaxel-coated devices over three years.
Three-year data from the randomized SIRONA trial, presented at the TCT 2026 conference, indicate that patients with femoropopliteal artery disease treated with Concept Medical's MagicTouch PTA balloon achieved higher rates of freedom from clinically driven target lesion revascularization (cdTLR) than those treated with paclitaxel-coated balloons (PCB). The study found 88.2% of the sirolimus-treated group remained free from repeat procedures compared to 80.2% in the paclitaxel group.
Conducted across 25 centers in Germany and Austria, the trial monitored 482 patients. While the revascularization outcomes diverged after the first year, safety markers—including all-cause mortality and amputation rates—remained comparable between the two cohorts. Patient-reported quality of life and walking capacity also showed no significant differences.
The study, published in JACC: Cardiovascular Interventions, arrives as the vascular surgery community weighs the long-term safety profile of paclitaxel devices following data from other trials. Principal investigator Professor Ulf Teichgräber noted the findings support further investigation, though he cautioned that because the trial was initially powered for 12-month endpoints, the three-year analysis remains exploratory. Follow-up continues toward a five-year conclusion.