Sirolimus-Coated Balloons Yield Similar Efficacy to Paclitaxel-Coated Balloons in Treating PAD

The SIRONA study demonstrated that MagicTouch™️ sirolimus-coated balloons are non-inferior compared to paclitaxel-coated balloons with respect to efficacy in patients with femoropopliteal artery disease. The findings were reported at TCT 2024.

It is currently unknown whether or not sirolimus drug-coated balloons (DCB) hold key advantages over paclitaxel DCB in the treatment of peripheral arterial disease. To determine if sirolimus-coated balloon angioplasty is non-inferior to paclitaxel-coated balloon angioplasty, researchers analyzed 482 participants across 25 clinical European sites with Rutherford category 2 to 4 femoropopliteal artery disease. The population of interest were randomized 1:1 to receive angioplasty with either a sirolimus-coated balloon or a paclitaxel–coated balloon.

The key efficacy end point of primary patency at 12 months was achieved in 73.8% of patients in the sirolimus DCB group compared with 75.0% in the paclitaxel DCB group. Moreover, the researchers noted that the rate of the composite primary safety outcome at 12 months of clinically driven target vessel revascularization (cdTVR), major amputation, or death was 9.4% in the sirolimus DCB compared with 7.3% in the paclitaxel DCB.

“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, Department of Radiology, University Hospital Jena, Friedrich-Schiller-University Jena via a press release. “Understanding the safety and efficacy of these two types of balloons, especially compared to one another, can help provide the best patient care possible.”