Data from the SIRONA trial, presented at TCT 2024, indicate that sirolimus-coated balloons are non-inferior to paclitaxel-coated balloons in treating patients with femoropopliteal artery disease. The multicenter, investigator-initiated, randomized clinical trial assessed the safety and efficacy of MagicTouch sirolimus-coated balloons (Concept Medical) compared to paclitaxel-coated balloons.
The SIRONA trial enrolled 482 participants with Rutherford category 2-4 femoropopliteal artery disease across 25 clinical sites in Germany and Austria between April 2021 and September 2022. Participants were randomized 1:1 to receive angioplasty with either a sirolimus-coated balloon or a paclitaxel-coated balloon. Baseline patient characteristics were similar between the two groups. The mean lesion length was 84 ± 61 mm, with 34% of lesions totally occluded and 29% calcified (Peripheral Arterial Calcium Scoring System grade 4). Bailout stents were required in 22.8% of the sirolimus group and 20.3% of the paclitaxel group.
The primary efficacy endpoint, primary patency at 12 months, was 73.8% in the sirolimus drug-coated balloon (DCB) group and 75.0% in the paclitaxel DCB group (difference -1.2%, 95% CI: -9.7% to 7.4%, p=0.022 for non-inferiority). The composite primary safety outcome, defined as clinically driven target vessel revascularization (cdTVR), major amputation, or death at 12 months, occurred in 9.4% of the sirolimus DCB group versus 7.3% of the paclitaxel DCB group (difference 2.1%, 95% CI: -3.2% to 7.5%, p=0.003 for non-inferiority). Functional outcomes were similar between the two groups.
Clinical Implications
"This head-to-head comparison of sirolimus-coated balloons with paclitaxel-coated balloons during angioplasty of the femoropopliteal artery shows comparable results between the two study groups," said Ulf Teichgräber (University Hospital Jena, Jena, Germany). "Understanding the safety and efficacy of these two types of balloons, especially compared to one another, can help provide the best patient care possible."
The SIRONA trial provides evidence supporting the use of sirolimus-coated balloons as a viable alternative to paclitaxel-coated balloons for angioplasty in patients with femoropopliteal artery disease. The similar efficacy and safety profiles observed in the trial suggest that sirolimus-coated balloons could be considered a standard treatment option for this condition.
