Long‐Term Efficacy and Safety of Sirolimus‐Coated Balloon in Femoropopliteal Steno‐Occlusive Disease: 3‐Year Outcomes

ABSTRACT Background Sirolimus‐coated balloon (SCB) is a potential treatment option for peripheral arterial disease (PAD). However, evidence is limited on the durability of the treatment effect in the longer term. Aims The aim of our study was to assess the long‐term efficacy and safety of SELUTION SCB in the treatment of the femoropopliteal steno‐occlusive disease. Methods This is a single‐center, all‐comers, observational registry in which 80 consecutive patients undergoing SELUTION SCB‐angioplasty due to femoropopliteal steno‐occlusive lesions were enrolled from February 2021 to March 2022. Assessments through 3 years included: primary patency (primary efficacy outcome), defined as freedom from restenosis determined by a duplex ultrasound peak systolic velocity ratio (PSVR) ≤ 2.4; freedom from clinically‐driven target lesion revascularization (CD‐TLR) and secondary patency, defined as freedom from new restenosis following the CD‐TLR (secondary efficacy outcomes); freedom from major adverse limb events (MALEs, primary composite safety outcome); change in median ankle‐brachial index (ABI) and Rutherford classification (functional outcomes). Results At 3 years, primary patency was 74.7% and freedom from CD‐TLR was 85.3%. The rate of CD‐TLR was 14.7% (11 patients). Among them, one patient experienced a new restenosis (failure of CD‐TLR), therefore secondary patency was 90.9%. Freedom from MALEs was 94.7%. Median ABI increased significantly from 0.4 ± 0.2 at baseline to 0.7 ± 0.3 at 36 months postprocedure, as well as Rutherford classification data improved. Conclusions These 3‐year findings suggest long‐term efficacy and safety of SELUTION SCB in the setting of femoropopliteal steno‐occlusive endovascular treatment. Larger cohorts and randomized controlled trials will be needed to confirm these results.