Clinical and angiographic outcomes of ultrathin biomime versus thicker ultimaster stents during primary percutaneous coronary interventions
Year: 2025
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
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.
Source: Romanian Journal of Cardiology
Institution: Assiut University
Language: English
Subfield: Surgery
Field: Medicine
Domain: Health Sciences
Open Access status: diamond
OpenAlex ID: W4416722595