title: 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.
abstract: OBJECTIVE
  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.
  REF/2016/07/011808.
authors: Krishna Institute of Medical Sciences, Secundrabad, India. Electronic address: kumarpre@hotmail.com.
authors: Rajendra Kumar
authors: RK
authors: Jain
authors: Krishna Institute of Medical Sciences, Secundrabad, India.
authors: Padmanabha
authors: P
authors: Chakravarthi
authors: Kasturba Medical College, Manipal, India.
authors: Rajan
authors: R
authors: Shetty
authors: Kasturba Medical College, Manipal, India.
authors: Padmakumar
authors: P
authors: Ramchandra
authors: Lalitha Super Specialty Hospital, Guntur, India.
authors: Raghava Sarma
authors: RS
authors: Polavarapu
authors: HERO DMC Heart Institute, Ludhiana, India.
authors: Gurupreet Singh
authors: GS
authors: Wander
authors: HERO DMC Heart Institute, Ludhiana, India.
authors: Bishav
authors: B
authors: Mohan
authors: Bankers Heart Institute, Baroda, India.
authors: Darshan Navinchandra
authors: DN
authors: Banker
authors: Shree Sai Baba Hospital, Nashik, India.
authors: Aniruddha
authors: A
authors: Dharmadhikari
authors: Metro Heart Institute, Faridabad, India.
authors: Shyam Sundar
authors: SS
authors: Bansal
authors: Metro Heart Institute, Faridabad, India.
authors: Neeraj
authors: N
authors: Jain
authors: Dhakkan Hospital, Rajkot, India.
authors: Dharmesh
authors: D
authors: Solanki
authors: Dhakkan Hospital, Rajkot, India.
authors: Jagdish
authors: J
authors: Dhakaan
authors: Shriram Cardiac Centre, Jalandhar, India.
authors: Ved Prakash
authors: VP
authors: Sharma
authors: Westford Hospital Group, Thrissur, India.
authors: Padhinhare P
authors: PP
authors: Mohanan
authors: Fathima Hospital, Calicut, India.
authors: Parayaru Kottayal
authors: PK
authors: Ashokan
authors: A.J. Hospital and Research Centre, Mangaluru, India.
authors: Bagur Venkat
authors: BV
authors: Manjunath
authors: G.S.S. Hospital and Trauma Centre, Hubli, India.
authors: Narendra
authors: N
authors: Hiregoudar
authors: Shri Sai Cardiac Centre, Kolhapur, India.
authors: Chandrashekar
authors: C
authors: Patil
authors: Lourdes Heart Institute, Cochin, India.
authors: Narasimha
authors: N
authors: Balakrishnan
mesh_terms: D020341:Absorbable Implants; D003324:Coronary Artery Disease / Q000601:surgery*; D054855:Drug-Eluting Stents; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000494:pharmacology; D015994:Incidence; D007194:India / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D062645:Percutaneous Coronary Intervention / Q000379:methods*; D011108:Polymers; D011183:Postoperative Complications / Q000453:epidemiology; D011474:Prosthesis Design; D020123:Sirolimus / Q000494:pharmacology*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D007166:Immunosuppressive Agents; D011108:Polymers; D020123:Sirolimus
keywords: Biodegradable polymer; Cobalt–chromium; Hybrid cell design; Sirolimus-eluting stent