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

Research output: Contribution to journalArticle

8 Citations (Scopus)

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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Sirolimus
Stents
Coronary Artery Disease
Polymers
Myocardial Infarction
Marketing
India
Cause of Death
Safety

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

Cite this

Jain, Rajendra Kumar ; Chakravarthi, Padmanabha ; Shetty, Rajan ; Ramchandra, Padmakumar ; Polavarapu, Raghava Sarma ; Wander, Gurupreet Singh ; Mohan, Bishav ; Banker, Darshan Navinchandra ; Dharmadhikari, Aniruddha ; Bansal, Shyam Sundar ; Jain, Neeraj ; Solanki, Dharmesh ; Dhakaan, Jagdish ; Sharma, Ved Prakash ; Mohanan, Padhinhare P. ; Ashokan, Parayaru Kottayal ; Manjunath, Bagur Venkat ; Hiregoudar, Narendra ; Patil, Chandrashekar ; Balakrishnan, Narasimha. / 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. In: Indian Heart Journal. 2016 ; Vol. 68, No. 5. pp. 599-603.
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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 = "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.",
author = "Jain, {Rajendra Kumar} and Padmanabha Chakravarthi and Rajan Shetty and Padmakumar Ramchandra and Polavarapu, {Raghava Sarma} and Wander, {Gurupreet Singh} and Bishav Mohan and Banker, {Darshan Navinchandra} and Aniruddha Dharmadhikari and Bansal, {Shyam Sundar} and Neeraj Jain and Dharmesh Solanki and Jagdish Dhakaan and Sharma, {Ved Prakash} and Mohanan, {Padhinhare P.} and Ashokan, {Parayaru Kottayal} and Manjunath, {Bagur Venkat} and Narendra Hiregoudar and Chandrashekar Patil and Narasimha Balakrishnan",
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Jain, RK, Chakravarthi, P, Shetty, R, Ramchandra, P, Polavarapu, RS, Wander, GS, Mohan, B, Banker, DN, Dharmadhikari, A, Bansal, SS, Jain, N, Solanki, D, Dhakaan, J, Sharma, VP, Mohanan, PP, Ashokan, PK, Manjunath, BV, Hiregoudar, N, Patil, C & Balakrishnan, N 2016, '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', Indian Heart Journal, vol. 68, no. 5, pp. 599-603. https://doi.org/10.1016/j.ihj.2016.09.007

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

In: Indian Heart Journal, Vol. 68, No. 5, 01.09.2016, p. 599-603.

Research output: Contribution to journalArticle

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.

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