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

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.