Endovascular Treatment of Femoro-Popliteal Disease with the Supera Stent: A Single Center Experience

Background/Objectives: Peripheral artery disease (PAD) is a significant global health challenge, affecting millions worldwide. Among its various manifestations, femoropopliteal atherosclerotic disease presents a unique challenge due to the biomechanical stresses on the superficial femoral artery (SFA) and popliteal artery (PA). Despite advancements in endovascular interventions, restenosis and stent fractures remain critical issues, particularly in complex and long lesions. Biomimetic stents, such as the SUPERA interwoven nitinol stent, have been developed to address these challenges by closely replicating the natural mechanical properties of the femoropopliteal arteries. This study evaluates the clinical and procedural outcomes of biomimetic stent implantation in patients with femoropopliteal atherosclerotic disease, focusing on patency rates, procedural success, and major adverse limb events (MALE). Methods: A cohort study was conducted at the University Clinical Center of Serbia, including 294 patients with femoropopliteal stenosis or occlusion treated with the SUPERA stent from January 2017 to December 2024. Patients were stratified by lesion complexity using the GLASS classification and procedural success, patency rates, and MALE incidence were assessed. Kaplan-Meier survival analysis was used to evaluate long-term outcomes, and Cox regression analysis identified predictors of MALE. Results: Primary patency rates at 1, 6, 12, and 24 months were 95.6%, 90.1%, 84.2%, and 77.7%, respectively. Primary-assisted patency and secondary patency rates remained high over time. Patients with GLASS IV lesions exhibited significantly lower patency rates and higher MALE incidence compared to GLASS I-III patients (p = 0.002). Occlusion length (≥16 cm) and lesion complexity (GLASS IV) were independent predictors of MALE (p = 0.015). The stent demonstrated high procedural success and durability, with minimal complications. Conclusions: Biomimetic SUPERA stents provide high patency rates and favorable clinical outcomes in complex femoropopliteal lesions. However, lesion complexity and occlusion length significantly impact long-term success. The findings highlight the importance of careful patient selection and lesion assessment for optimizing endovascular treatment strategies in PAD management.