One-year outcomes of polymer-free Sirolimus-eluting stents in complex femoropopliteal stenosis: a single center real-world registry.

Abstract

Background: Lower extremity arterial disease is a prevalent vascular condition leading to ischemic symptoms and increased risk of cardiovascular events. Drug-eluting stents have improved outcomes by reducing restenosis, with sirolimus emerging as a promising alternative to paclitaxel due to its safer profile. This study evaluates the efficacy and safety of novel polymer-free Amphilimus^™ formulation (Sirolimus + fatty acid) eluting self-expanding stent in the treatment of femoropopliteal disease in a real-world population.

Methods: A prospective, single-center study was conducted from November 2022 to January 2024, including 78 patients with femoropopliteal artery disease. Patients underwent percutaneous transluminal angioplasty with stent implantation and follow-up at discharge, 30 days, 6 and 12 months. The primary endpoints were overall and device related major adverse events and primary patency at 12 months. Secondary endpoints included freedom from clinically driven target lesion revascularization and the presence of the HALO effect on ultrasound.

Results: The mean age of patients was 68.5±9.4 years and mean target lesion length was 151±75 mm. The occlusions were 39% while 48.1% of patients had chronic limb threatening ischemia. Device and clinical success were obtained in all cases. At 12 months, primary patency was 87%, freedom from clinically driven target lesion revascularization was 92.2% and overall freedom from major adverse events was 89%. No HALO effect was observed.

Conclusions: These findings suggest that using a novel polymer-free sirolimus self-expanding stent is a safe and effective treatment option for femoropopliteal lesions, supporting its use in routine clinical practice.