Long-Term Safety and Performance of BioMimeTM Morph Sirolimus-Eluting Coronary Stent System for Very Long Coronary Lesions

Abstract

Background: The use of multiple overlapping stents for long lesions in tapered coronary arteries has been associated with poor outcomes. This study was conducted to evaluate the 3-year safety and performance of the BioMime^TM Morph sirolimus-eluting stent (SES) in very long (length 30 to 56 mm) coronary lesions in native coronary arteries with a reference vessel diameter of 2.25 to 3.50 mm.

Methods: This was a prospective, single-center, observational, real-world, post-marketing surveillance study. Eligible patients were implanted with BioMime^TM Morph SES. Patients were followed up at 6, 12, 24, and 36 months.

Results: A total of 88 patients were enrolled in the study. The mean age was 58.72 10.10 years and 82.95% were male. Most patients had angina (81.82%) and ischemic heart disease (78.41%), and there was a high prevalence of comorbidities like diabetes mellitus (59.09%), and hypertension (54.55%). A total of 92 long coronary de novo lesions were treated with BioMime^TM Morph SES with an average stent length of 45.54 10.20 mm. Device and procedural success rates were 100%. One patient died at 30 days and one case of myocardial infarction was recorded. The cumulative rates of major adverse cardiovascular events (MACEs) at 6, 12, 24, and 36 months were 3.41%, 6.82%, 7.95%, and 7.95%, respectively. There were no cases of stent thrombosis (ST), ischemia-driven target vessel revascularization, or ischemia-driven target lesion revascularization until 36 months of follow-up.

Conclusion: BioMime^TM Morph SES showed favorable outcomes up to 3 years in treating very long coronary lesions in native coronary arteries, as demonstrated by an acceptable rate of MACEs and absence of ST, based on clinical outcomes up to 3 years.

Cardiol Res. 2024;15(3):169-178
doi: https://doi.org/10.14740/cr1626