SIRONA study reports three-year data for sirolimus-coated balloon in peripheral artery disease
The MagicTouch PTA sirolimus-coated balloon demonstrated a higher rate of freedom from target lesion revascularization compared to paclitaxel-coated balloons at three years.
Three-year results from the randomized SIRONA study indicate that the MagicTouch PTA sirolimus-coated balloon (SCB) from Concept Medical resulted in more frequent freedom from clinically driven target lesion revascularization (cdTLR) compared to paclitaxel-coated balloons (PCB) in patients with femoropopliteal artery disease. The findings were presented at the TCT 2026 conference and published in JACC: Cardiovascular Interventions.
The multicenter study involved 482 patients across Germany and Austria. At the three-year mark, freedom from cdTLR was 88.2% for the SCB group compared to 80.2% for the PCB group. While the divergence in revascularization rates appeared after the first year, there were no observed differences in secondary endpoints, including quality of life, walking capacity, or clinical safety metrics such as mortality.
These findings arrive amid ongoing scrutiny regarding the use of paclitaxel-coated devices in peripheral interventions. Lead investigator Professor Ulf Teichgräber noted that because the study was originally powered for 12-month outcomes, the three-year results are exploratory and will require continued observation through the planned five-year follow-up period to confirm the clinical significance of the findings.