Objective: Supraflex (Sahajanand Medical Technologies Pvt. Ltd, Surat, India) is the latest generation of biodegradable polymer-coated sirolimus-eluting coronary stent designed on ultra-thin (60 µm) cobalt–chromium platform with flexible “S-link.” The present study was designed to establish the safety and clinical performance of Supraflex in real-world Indian patients with coronary artery disease.
Materials and Methods: The study included 839 consecutive patients with coronary artery disease who were implanted with Supraflex from January 2014 to August 2017 at six different tertiary care centers in India. Follow-up was performed at 30 days, 6 months, and 12 months after the index procedure. The primary end-point of the study was the incidence of major adverse cardiac events (MACE), a composite of cardiac death, myocardial infarction (MI), and target lesion revascularization (TLR) at the 12-month follow-up. The occurrence of stent thrombosis was analyzed as safety end-point.
Results: A total of 1025 lesions were treated by implantation of 1098 Supraflex stents. At the 12-month follow-up, MACE was 4.92%, including 7 (0.86%) cardiac deaths, 16 (1.97%) MI, and 17 (2.09%) TLR. Only three incidences of stent thrombosis were found at the 12-month follow-up.
Conclusion: The study results showed excellent safety and clinical effectiveness of Supraflex in a high proportion of high-risk real-world Indian patients with coronary artery disease.