Author + information
- Ashok seth1,
- Gurpreet Wander2,
- Mullasari Ajit Sankardas3,
- Manjunath Cholenahally Nanjappa4,
- Prabhakara Shetty Heggunje5,
- Thomas Alexander6,
- Suhas Prahlad Hardas7,
- Mathew Samuel Kalaricka8,
- Sunitha Abraham9,
- Suresh G. Vijan10,
- Rohit Manoj Manoj11 and
- Alexandre Abizaid12
- 1Fortis Escorts Heart Institute, New Delhi, India, New Delhi, India
- 2Hero DMC Heart Institute Dayanand Medical College and Hospital, Ludhiana, India
- 3The Madras Medical Mission, Chennai, India
- 4Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore, India
- 5Columbia Asia Hospital, Bangalore, Bangalore, India
- 6Kovai Medical Centre and Hospital, Coimbatore, India
- 7Poona Hospital & Research Centre, Pune, India
- 8Apollo Group of Hospitals, Chennai, India
- 9Narayana Hrudayalaya Institute of Medical Sciences, Bengaluru, India
- 10Fortis Hospital, Mumbai, India
- 11Advance Cardiac Centre, PGIMER, Chandigarh, India
- 12Director, Interventional Cardiology Instituto Dante Pazzanese de Cardiologia São Paulo, Brazil, São Paulo, Brazil
The development of biodegradable polymer-coated Sirolimus-Eluting Coronary Stent (SES) System for the treatment of coronary artery diseases has resulted inconsiderable improvements in clinical outcomes. The aim of the meriT-2 study was to determine the long-term safety and performance of the BioMime Sirolimus-Eluting Coronary Stent System (Meril Life Sciences Pvt. Ltd., Gujarat, India) for the treatment of coronary artery disease patients.
The meriT-2 was a prospective, multicenter study conducted in 250 patients at 11 Indian sites. The primary endpoint was major adverse cardiac events (MACE) defined as a composite of cardiac death, myocardial infarction (MI) and target lesion revascularization (TLR) at 30 days after the procedure. The primary efficacy endpoint was in-stent late lumen loss (LLL) at eight months. The secondary endpoints were MACE and stent thrombosis (ST)at one-year follow-up. The clinical follow-up was performed at the following time points: 30 days, six months, one year, and three-year after index procedure. Recently, follow-up was performed at three-year and the resultant cumulative MACE was analyzed.
Follow-up at three-year was available for 242 patients (96.8%). Among those 123 (49.2%) patients had hypertension and 91 (36.4%) patients with diabetes mellitus. Out of 355 lesions, 63.4% lesions were type B2/C as defined by the ACC/AHA guidelines. The cumulative MACE was 18 (7.4%), including 2(0.8%) cardiac deaths, 4 (1.6%) MI, and 12 (4.8%) any-TLR. Stent thrombosis was observed in 3 (1.2%) patients.
Long-term clinical outcomes of BioMime SES at 3 year follow-up demonstrated excellent safety and performance in a coronary artery disease patient population with a high prevalence of hypertension, diabetes and complex lesions.