AIMS:

The purpose of the study was to evaluate long-term safety and clinical performance of Supralimus-Core (Sahajanand Medical Technologies Pvt. Ltd., Surat, India) in unselected real-world complex cohort of saudi patients with coronary artery disease.

METHODS AND RESULTS:

SCORES was a multi-centre, observational, non-randomised, post-marketing surveillance registry enrolling patients who had undergone implantation with study stent. The primary end-point of the study was occurrence of major adverse cardiac events (MACE) at 7-years, which is a conglomeration of cardiac death, myocardial infarction, target lesion revascularization (TLR), target vessel revascularization (TVR) and stent thrombosis (ST). A total of 517 patients were intervened successfully with 1044 sirolimus eluting stents. Out of total patients, diabetes and hypertension were observed in 54.0% and 50.5% patients, respectively. The registry involved highly complex lesions, which is demonstrated by 10.5% bifurcation lesion, 13.6% total occlusion, 5.9% restenotic lesions, 8.5% long (>30 mm) lesions, and 14.5% calcified lesions. At least one-year follow-up was completed in 98.3% patients. Median and interquartile follow-up of surviving patients was 5.6 (range, 3.8 - 7.2) years. Long-term follow-up upto 7-year was obtained in 95.5% patients. At 7-year, MACE was found to be 15.2%, which is a composite of 6.9% cardiac death, 6.1% TLR, 1.2% TVR and 0.4% ST. The event free survival by Kaplan Meier method was found to be 84.8%.

CONCLUSION:

The low incidence of late and very late ST and consequent MACE at long-term follow-up clearly depict excellent safety and clinical performance of Supralimus-Core in unselected real-world complex cohort of saudi patients with coronary artery disease.