SIRONA study reports lower repeat intervention rates with sirolimus-coated balloon
A three-year follow-up of the SIRONA study compares sirolimus-coated balloons against paclitaxel-based alternatives for peripheral artery disease.
Three-year data 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, involving 482 patients across 25 centers in Germany and Austria, found that freedom from clinically driven target lesion revascularization (cdTLR) was 88.2% for the SCB group and 80.2% for the PCB group after three years. While the difference became statistically significant after the first year, there were no notable discrepancies between the groups regarding patient-reported quality of life, mobility, or mortality rates.
Led by Professor Ulf Teichgräber, the study provides a comparison between two different drug-coated technologies in the treatment of femoropopliteal disease. These findings are particularly relevant following ongoing industry scrutiny regarding the long-term safety profile of paclitaxel-coated implants.
Because the SIRONA trial was originally powered for 12-month endpoints, researchers characterized the three-year results as exploratory. Long-term follow-up is scheduled to continue for five years.