Dr. Selvi Öztaş

Name of the Study: Head-to-head Comparison of Sirolimus Versus Paclitaxel-Coated Balloon Angioplasty in the Femoropopliteal Artery: The Randomized Controlled SIRONA trial

Published in Congress: TCT 2024

Link: https://www.tctmd.com/slide/head-head-comparison-sirolimus-versus-paclitaxel-coated-balloon-angioplasty-femoropopliteal

Objective:
Endovascular revascularization has been established as the first-line therapy of femoropopliteal artery disease. Paclitaxel-coated balloon angioplasty proved superior to plain old balloon angioplasty (POBA) regarding the prevention of restenosis and the need for recurrent revascularization. Over the past years, paclitaxel has been the only active drug that inhibits neointimal proliferation, and it could be processed into an appropriate balloon coating.  The purpose of this study is to assess whether the efficacy and safety of sirolimus-coated balloon angioplasty is non-inferior to paclitaxel-coated balloon angioplasty.

Methods:
This randomized, controlled, single-blinded, multicentre, investigator-initiated noninferiority trial aims to enroll a total of 482 participants with symptomatic femoropopliteal artery disease of Rutherford category 2 to 4 due to de novo stenosis or restenosis. After pre-dilation, participants were allocated in a 1:1 ratio to either sirolimus- or paclitaxel-coated balloon angioplasty. Post-dilation with the drug-coated balloon (DCB) used or standard balloon is mandatory in cases? 50%, and optional in cases of ? 30% residual diameter stenosis. Bailout stenting with bare metal nitinol stents should be conducted in case of flow-limiting dissection. Primary noninferiority endpoints are primary patency and the composite of all-cause mortality, major target limb amputation, and clinically driven target lesion revascularization (cdTLR) at 12 months. Secondary outcomes are clinical and hemodynamic improvement, change in health-related quality of life, and safety throughout 60 months.

Results:
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 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 cdTLR, 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.

Conclusion:
The head-to-head comparison of sirolimus DCB with paclitaxel DCB shows comparable results between the study groups: Primary patency of sirolimus DCB was non-inferior to that of paclitaxel DCB. No significant difference between groups in freedom from cdTLR. Clinical improvement of sirolimus DCB was similar to paclitaxel DCB. The safety of sirolimus DCB was non-inferior to that of paclitaxel DCB.

Comment:
The need for target lesion revascularization is high in this disease group and more powerful treatments are still needed. However, these results from sirolimus-coated balloons were promising in knowing that we have an equivalent alternative to the paclitaxel-coated balloon.