Key result
The BioMime Sirolimus-Eluting Coronary Stent System demonstrated a 1-year cumulative major adverse cardiac event rate of 2.35% in all-comer patients with coronary artery disease.
Observational (n=1,161)
Yes
The BioMime Sirolimus-Eluting Coronary Stent System demonstrated low rates of MACE (2.35%) at 1 year in a real-world, all-comers CAD population in India.
Supports BioMime stent safety in real-world Indian CAD patients; extends observational data but leaves open need for RCTs.
OBJECTIVES: The aim of the merit-3 study was to determine the safety and performance of the BioMime Sirolimus-Eluting Coronary Stent System (SES) in all-comer patients with coronary artery disease (CAD) in one-year clinical follow-up period. METHODS: The meriT-3 was a multi-centre, observational, post-marketing study conducted in 1161 patients with CAD who were implanted with BioMime SES at 15 sites in India. The primary endpoint was major adverse cardiac event (MACE) at one year defined as the composite of cardiac death, myocardial infarction (MI) and target lesion revascularization (TLR). Clinical follow-up was performed at 1, 6, and 12 months. Major adverse cardiac event occurred at 30 days and subsequently at 6 months and at long-term follow-up of 1 year was analyzed. RESULTS: MACE observed at 1 and 6 months follow-up was 16 (1.38%) and 21 (1.83%) respectively. Cumulative 1 year MACE was 26 (2.35%) with 16 (1.39%) all cause death, 4 (0.35%) MI and 6 (0.52%) TLR. In addition, ST was observed in 1 (0.09%) patient. CONCLUSIONS: The present study suggests that the BioMime SES is safe and effective in a "real-world", all-comers CAD patients, indicating low rates of MACE. CTRI ACKNOWLEDGEMENT NO: REF/2016/07/011808.
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Jain et al. (2016) conducted an observational in Coronary artery disease (CAD) (n=1,161). BioMime Sirolimus-Eluting Coronary Stent System (SES) was evaluated on Major adverse cardiac event (MACE) at one year defined as the composite of cardiac death, myocardial infarction (MI) and target lesion revascularization (TLR). The BioMime Sirolimus-Eluting Coronary Stent System demonstrated a 1-year cumulative major adverse cardiac event rate of 2.35% in all-comer patients with coronary artery disease.
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