Twelve-month clinical outcomes of sirolimus-eluting stent in coronary artery disease: An experience in real-world Indian patients.

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.

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.