Sirolimus-coated balloons were noninferior to paclitaxel-coated balloons in terms of safety and efficacy in treating patients with femoropopliteal artery disease, based on findings from the head-to-head SIRONA trial presented at TCT 2024.

Researchers enrolled 482 participants with Rutherford category 2 to 4 femoropopliteal artery disease from 25 clinical sites in Germany and Austria from April 2021 to September 2022. Patients were randomly assigned 1:1 to receive angioplasty with a sirolimus-coated balloon or a paclitaxel-coated balloon. Baseline characteristics were similar across both groups. The mean lesion length was 84 ± 61 mm. A total of 34% of the lesions were totally occluded and 29% were calcified according to PACSS grade 4.

Overarching results found the rate of the primary efficacy endpoint of primary patency at 12 months was 73.8% in the sirolimus group compared with 75.0% in the paclitaxel group [Rate difference: -1.2% (-9.7% to 7.4%, p=0.022, noninferiority)]. The rate of the composite primary safety outcome at 12 months of clinically driven target vessel revascularization, major amputation, or death was 9.4% in the sirolimus DCB vs. 7.3% in the paclitaxel DCB. Functional outcomes were similar between the two groups. Researchers noted that bailout stents were implanted in 22.8% of the sirolimus group and 20.3% of the paclitaxel group lesions.

"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, MD, MBA, MME. "Understanding the safety and efficacy of these two types of balloons, especially compared to one another, can help provide the best patient care possible."