Interim Results of the Basket of Real-World Randomised Clinical PRISM Trials for M’Sure-S, a Next-Generation Sirolimus-Eluting Stent, Versus Eliminator, an Everolimus-Eluting Stent

Abstract

Objective: This study compared sirolimus-eluting stents (SES) with everolimus-eluting stents (EES) in coronary artery disease patients. Methods: A total of 1,174 patients were enrolled in the study; 290 patients (25.28%) were treated with EES and 884 patients (74.72%) were treated with SES. The trial (PRISM) was a randomised (in a 3:1 ratio), multicentre, single-blind, all-comers, single-arm, non-inferiority trial comparing SES and EES-implanted patients with coronary artery disease. The primary endpoint was a composite of safety parameters (including major adverse cardiac events [MACE], cardiac death, and myocardial infarction) and efficacy (parameters concerned to quantitative coronary angiogram). An intention-to-treat analysis was performed at 9 and 18-month follow-ups. Results: The baseline characteristics were similar for both EES and SES groups. At the 9-month follow-up, MACE occurred in 5.86% and 2.43% of patients in the EES and SES groups, respectively. At the 18-month follow-up, this differential remained almost the same (i.e., 5.17 % of patients treated with the EES versus 2.14% treated with the SES). The rate of definite stent thrombosis at 9-month follow-up was lower in the SES group (11 patients [1.24%]) compared to the EES group (9 patients [3.10%]). At 18-month follow-up, the rate was 2.14% (19 patients) in the SES group and 4.13% (12 patients) in the EES group. When censoring the patients at the time of stent thrombosis, no significant differences between the two stent groups were found. Conclusion: In this real-world trial, at 9 and 18-month follow-ups, SES (M’Sure-S) exhibited a better safety and efficacy profile when compared to EES in terms of MACE rates and definite stent thrombosis. However, the difference was not statistically significant and SES was found to be non-inferior to EES.