TY - JOUR
T1 - One-year outcomes of a BioMime™ Sirolimus-Eluting Coronary Stent System with a biodegradable polymer in all-comers coronary artery disease patients
T2 - The meriT-3 study
AU - Jain, Rajendra Kumar
AU - Chakravarthi, Padmanabha
AU - Shetty, Rajan
AU - Ramchandra, Padmakumar
AU - Polavarapu, Raghava Sarma
AU - Wander, Gurupreet Singh
AU - Mohan, Bishav
AU - Banker, Darshan Navinchandra
AU - Dharmadhikari, Aniruddha
AU - Bansal, Shyam Sundar
AU - Jain, Neeraj
AU - Solanki, Dharmesh
AU - Dhakaan, Jagdish
AU - Sharma, Ved Prakash
AU - Mohanan, Padhinhare P.
AU - Ashokan, Parayaru Kottayal
AU - Manjunath, Bagur Venkat
AU - Hiregoudar, Narendra
AU - Patil, Chandrashekar
AU - Balakrishnan, Narasimha
PY - 2016/9/1
Y1 - 2016/9/1
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=84994526831&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84994526831&partnerID=8YFLogxK
U2 - 10.1016/j.ihj.2016.09.007
DO - 10.1016/j.ihj.2016.09.007
M3 - Article
C2 - 27773396
AN - SCOPUS:84994526831
SN - 0019-4832
VL - 68
SP - 599
EP - 603
JO - Indian Heart Journal
JF - Indian Heart Journal
IS - 5
ER -