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Published on: May 14, 2013
Long-Term Safety and Performance of BioMime™ Morph Sirolimus-Eluting Coronary Stent System for Very Long Coronary
1Department of Cardiology, KLES Dr. Prabhakar Kore Hospital & Medical Research Centre, Nehru Nagar, Belagavi 590010, Karnataka, India.
Insights
The BioMime™ Morph sirolimus-eluting stent (SES) demonstrated favorable 3-year outcomes for long coronary lesions. This study found no stent thrombosis, showing its safety and effectiveness in complex cases.
Area of Science:
- Interventional Cardiology
- Medical Device Technology
- Clinical Outcomes Research
Background:
- Overlapping stents for long, tapered coronary lesions have shown poor outcomes.
- The BioMime™ Morph sirolimus-eluting stent (SES) is designed for complex coronary anatomies.
Purpose of the Study:
- To evaluate the 3-year safety and performance of the BioMime™ Morph SES.
- To assess outcomes in patients with very long coronary lesions in native arteries.
Main Methods:
- Prospective, single-center, observational, real-world study.
- 88 patients with 92 long coronary lesions treated with BioMime™ Morph SES.
- Follow-up at 6, 12, 24, and 36 months.
Main Results:
- 100% device and procedural success.
- Cumulative major adverse cardiovascular events (MACEs) at 3 years was 7.95%.
- No cases of stent thrombosis (ST) or ischemia-driven revascularization observed up to 36 months.
Conclusions:
- BioMime™ Morph SES shows favorable 3-year outcomes for very long coronary lesions.
- The stent demonstrated an acceptable MACE rate and no stent thrombosis.
- This supports its use in complex, long coronary lesions.
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™ 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™ 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™ 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™ 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.
