A RECENT study has revealed that MagicTouch™ (Concept Medical, Tampa, Florida, USA) sirolimus-coated balloons are comparable to paclitaxel-coated balloons for treating femoropopliteal artery disease. The findings were drawn from the SIRONA trial, a multicenter, randomised clinical trial that enrolled 482 patients across 25 clinical sites in Germany and Austria.
The SIRONA trial aimed to determine whether sirolimus-coated balloons could provide comparable safety and efficacy outcomes to paclitaxel-coated balloons, which are already widely used in peripheral artery disease treatments. Patients with Rutherford Category 2 to 4 femoropopliteal artery disease, a condition affecting the arteries of the thigh and knee, were randomly assigned to receive one of the two treatments. The study tracked both primary safety and efficacy endpoints over a 12-month period.
Results showed that the rate of primary patency was 73.8% in the sirolimus group compared to 75.0% in the paclitaxel group. With a rate difference of -1.2%, this met the noninferiority criteria. The primary safety outcome, which included clinically driven target vessel revascularisation, major amputation, or death, occurred in 9.4% of the sirolimus group, compared to 7.3% in the paclitaxel group. This difference of 2.1% also fell within noninferiority margins.
The findings also highlighted similar functional outcomes between the two groups, reinforcing that both treatments offer comparable benefits. The use of bailout stents, which were required in 22.8% of the sirolimus group and 20.3% of the paclitaxel group, also showed minimal difference.
Ulf Teichgräber, lead investigator from Jena University Hospital, Germany emphasised the importance of these results, stating: “This head-to-head comparison of sirolimus-coated and paclitaxel-coated balloons shows comparable results, helping guide clinical decisions for optimal patient care in treating femoropopliteal artery disease.”
Reference
Teichgräber U. Head-to-head comparison of sirolimus- versus paclitaxel-coated balloon angioplasty in the femoropopliteal artery. TCT 2024, 29 October, 2024
