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Observational Study
. 2016 Sep-Oct;68(5):599-603.
doi: 10.1016/j.ihj.2016.09.007. Epub 2016 Sep 28.

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  1 , Padmanabha Chakravarthi  2 , Rajan Shetty  3 , Padmakumar Ramchandra  3 , Raghava Sarma Polavarapu  4 , Gurupreet Singh Wander  5 , Bishav Mohan  5 , Darshan Navinchandra Banker  6 , Aniruddha Dharmadhikari  7 , Shyam Sundar Bansal  8 , Neeraj Jain  8 , Dharmesh Solanki  9 , Jagdish Dhakaan  9 , Ved Prakash Sharma  10 , Padhinhare P Mohanan  11 , Parayaru Kottayal Ashokan  12 , Bagur Venkat Manjunath  13 , Narendra Hiregoudar  14 , Chandrashekar Patil  15 , Narasimha Balakrishnan  16
Affiliations
Observational Study

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 et al. Indian Heart J. 2016 Sep-Oct.

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.

Keywords: Biodegradable polymer; Cobalt–chromium; Hybrid cell design; Sirolimus-eluting stent.

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Figures

Fig. 1
Fig. 1
Time-to-event curve at up to 1-year follow-up by Kaplan–Meier method.
See this image and copyright information in PMC

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