SIRONA Trial Compares Sirolimus Versus Paclitaxel DCBs to Treat Peripheral Artery Disease

October 29, 2024—Data from the prospective, multicenter, investigator-initiated SIRONA randomized clinical trial demonstrated that the MagicTouch sirolimus-coated balloon (Concept Medical, Inc.) was noninferior compared to a paclitaxel-coated balloons in terms of primary safety and efficacy endpoints in patients with femoropopliteal artery disease.

The findings from SIRONA were presented at TCT 2024, the 36th annual Transcatheter Cardiovascular Therapeutics annual scientific symposium of the Cardiovascular Research Foundation held October 27-30 in Washington, DC.

According to TCT, the SIRONA study investigators enrolled 482 patients at 25 clinical sites in Germany and Austria from April 2021 to September 2022. The enrolled patients—who had Rutherford category 2 to 4 femoropopliteal artery disease—were randomized 1:1 to receive angioplasty with either a sirolimus-coated balloon or a paclitaxel-coated balloon. Patient characteristics were similar between both groups.

The mean lesion length was 84 ± 61 mm; 34% of lesions were totally occluded; and 29% of lesions were calcified according to the Peripheral Arterial Calcium Scoring System grade 4. Bailout stents were implanted in 22.8% of the sirolimus group and 20.3% of the paclitaxel group lesions [difference: 2.5%; 95% CI, –4.9% to 9.8%).

As reported the TCT press release, the rate of the primary efficacy endpoint of primary patency at 12 months was 73.8% in the sirolimus drug-coated balloon (DCB) group compared with 75.0% in the paclitaxel DCB group (rate difference, –1.2%: –9.7% to 7.4%; P = .022, noninferiority).

The primary safety outcome—the rate of a composite of clinically driven target vessel revascularization, major amputation, or death at 12 months—was 9.4% in the sirolimus DCB versus 7.3% in the paclitaxel DCB (between-group difference: 2.1%; 95% CI, –3.2% to 7.5%; P = .003, noninferiority). Functional outcomes were similar between the two groups, noted the TCT press release.

“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,” commented Ulf Teichgräber, MD, in the TCT 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.”

Dr. Teichgräber is from the Department of Radiology, University Hospital Jena, Friedrich-Schiller-University Jena in Jena, Germany.