OBJECTIVE The aim of this work was to compare the safety and effectiveness of the BioMime and the thicker strut Ultimaster sirolimus-eluting stents (SESs) in patients presenting with ST-elevation myocardial infarction (STEMI) and single-vessel disease undergoing primary percutaneous coronary intervention (PCI).
METHOD This prospective, single-center, non-inferiority study was carried out on 221 STEMI individuals aged 19 to 65 years, both sexes, diagnosed with STEMI. All patients were subjected to electrocardiograms, echocardiography, and clinical follow-up. Quantitative coronary angiography was done at baseline and follow-up.
RESULTS Post-procedure quantitative coronary angiography (QCA) demonstrated no significant differences regarding acute luminal gain and residual stenosis between the BioMime and Ultimaster groups. Binary restenosis was slightly greater in the BioMime group (7 [15.2%]) compared to the Ultimaster group (6 [13.3%], relative risk [95% confidence interval, CI]: 0.947 [0.329–2.725], P = 0.797). The variation in in-stent late lumen loss (LLL) between the groups was minimal (0.33 ± 0.3 mm in the BioMime group vs. 0.32 ± 0.4 mm in the Ultimaster group, Diff [95% CI]: 0.007 [−0.16–0.17], P = 0.935; prespecified non-inferiority = 0.024). Clinical endpoints at 30 days and 14 months, as well as patient- and device-oriented endpoints at 14 months, were not significantly different between the BioMime and Ultimaster groups. Subgroup analysis revealed a potential benefit of the Ultimaster stent in older patients (>70 years) regarding target vessel failure (TVF).
CONCLUSION In primary PCI for STEMI patients, BioMime stents were non-inferior to Ultimaster stents at one-year follow-up. Further studies with longer follow-up durations are warranted to validate these results.
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