Clinical and angiographic outcomes of ultrathin biomime versus thicker ultimaster stents during primary percutaneous coronary interventions

Abstract Objectives The aim of this study was to examine the safety and effectiveness of the Biomime sirolimus-eluting stent (SES) versus a thicker-strut Ultimaster SES in cases presenting with ST-elevation myocardial infarction (STEMI) who were subjected to primary PCI. Methods For this prospective, single-center, randomized, open-label, active-controlled, noninferiority trial, a sample of 370 STEMI patients were enrolled and randomly assigned (1:1) to be delivered Biomime SES and Ultimaster SES. Results Biomime was non-inferior to Ultimaster for target vessel failure (TVF) at one year at 20 (10.9%) vs. 14 (8.4%) relative risk (RR) (95% confidence interval [CI]: 1.296 [0.677–2.482], p = 0.432; P for non-inferiority [PNI] = 0.059). Additionally, there are no significant differences regarding major adverse cardiovascular events (MACE), which occurred at a rate of 30 (16.4%) in the Biomime group vs. 18 (10.5%) in the Ultimaster group; RR (95% CI): 1.512 (0.877–2.61), p = 0.133; (PNI) < 0.001). Angiographic follow-up revealed no significant difference in in-stent late lumen loss (LLL), at 0.34 ± 0.4 mm vs. 0.36 ± 0.4 mm; Diff (95% CI): -0.02 (-0.14 to 0.10), p = 0.756; PNI < 0.001). Conclusion In STEMI cases subjected to primary PCI, the Biomime SES was non-inferior to Ultimaster SES at one-year follow-up. Longer-term studies are warranted to confirm these findings.