Outcomes of SUPERA™ Stent Used for the Treatment of De novo or Restenotic Superficial Femoral Artery or Complex Femoropopliteal Artery Lesions in Indian Patients

Objective: The study was conducted to evaluate the treatment outcomes of SUPERA™ stents in patients with de novo or restenotic lesions in the superficial femoral artery (SFA) or femoropopliteal artery (FPA). Materials and Methods: A real-world data collection registry across 20 centers in India enrolled patients (≥18 years) with SFA or FPA lesions treated with SUPERA™ stents. The registry was approved by the ethics committees of the respective sites and 284 subjects were enrolled prospectively after informed consent was obtained; data were collected specifically for this particular analysis. It evaluated baseline characteristics, procedural details, and quality of life, with primary outcome as 12-month freedom from target lesion revascularisation (TLR). Secondary outcomes included patency rate, stent fractures, all-cause death, clinical improvement on Rutherford–Becker classification, and health-related quality of life (HRQoL) using a 36-item Short Form Survey questionnaire. Comparisons were made between baseline and 12 months using Kaplan–Meier analysis, t -tests, and proportional comparisons. Results: At 12 months, 90.3% of patients were free from TLR, and 89.2% maintained primary patency with SUPERA™ stents; the all-cause death rate was 90.58%. Patients’ HRQoL showed significant improvement and 92% of the patients showed clinical improvement as per the Rutherford–Becker classification. No stent fractures were reported. A total of 12.7%, 75%, and 12.3% of patients were prescribed mono antiplatelet therapy, dual antiplatelet therapy, or triple antiplatelet therapy. Conclusion: SUPERA™ stents show promise in the management of peripheral artery disease with appreciable freedom from TLR, good primary patency, and notable improvements in HRQoL at 12 months.