One-year outcomes of a BioMime™ Sirolimus-Eluting Coronary Stent System with a biodegradable polymer in all-comers coronary artery disease patients: The meriT-3 study

Rajendra Kumar Jain, Padmanabha Chakravarthi, Rajan Shetty, Padmakumar Ramchandra, Raghava Sarma Polavarapu, Gurupreet Singh Wander, Bishav Mohan, Darshan Navinchandra Banker, Aniruddha Dharmadhikari, Shyam Sundar Bansal, Neeraj Jain, Dharmesh Solanki, Jagdish Dhakaan, Ved Prakash Sharma, Padhinhare P. Mohanan, Parayaru Kottayal Ashokan, Bagur Venkat Manjunath, Narendra Hiregoudar, Chandrashekar Patil, Narasimha Balakrishnan

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Abstract

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.

Original languageEnglish
Pages (from-to)599-603
Number of pages5
JournalIndian Heart Journal
Volume68
Issue number5
DOIs
Publication statusPublished - 01-09-2016
Externally publishedYes

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All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

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