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
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, po...
Main Authors: | , , , , , , , , , , , , , , , , , , , |
---|---|
Format: | Article |
Language: | English |
Published: |
Elsevier
2016-09-01
|
Series: | Indian Heart Journal |
Subjects: | |
Online Access: | http://www.sciencedirect.com/science/article/pii/S0019483216304059 |
_version_ | 1819093743513370624 |
---|---|
author | 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 |
author_facet | 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 |
author_sort | Rajendra Kumar Jain |
collection | DOAJ |
description | 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. |
first_indexed | 2024-12-21T23:16:22Z |
format | Article |
id | doaj.art-7ba8765f027a46028ab99262e5bd0c2a |
institution | Directory Open Access Journal |
issn | 0019-4832 |
language | English |
last_indexed | 2024-12-21T23:16:22Z |
publishDate | 2016-09-01 |
publisher | Elsevier |
record_format | Article |
series | Indian Heart Journal |
spelling | doaj.art-7ba8765f027a46028ab99262e5bd0c2a2022-12-21T18:46:55ZengElsevierIndian Heart Journal0019-48322016-09-0168559960310.1016/j.ihj.2016.09.007One-year outcomes of a BioMime™ Sirolimus-Eluting Coronary Stent System with a biodegradable polymer in all-comers coronary artery disease patients: The meriT-3 studyRajendra Kumar Jain0Padmanabha Chakravarthi1Rajan Shetty2Padmakumar Ramchandra3Raghava Sarma Polavarapu4Gurupreet Singh Wander5Bishav Mohan6Darshan Navinchandra Banker7Aniruddha Dharmadhikari8Shyam Sundar Bansal9Neeraj Jain10Dharmesh Solanki11Jagdish Dhakaan12Ved Prakash Sharma13Padhinhare P. Mohanan14Parayaru Kottayal Ashokan15Bagur Venkat Manjunath16Narendra Hiregoudar17Chandrashekar Patil18Narasimha Balakrishnan19Krishna Institute of Medical Sciences, Secundrabad, IndiaKrishna Institute of Medical Sciences, Secundrabad, IndiaKasturba Medical College, Manipal, IndiaKasturba Medical College, Manipal, IndiaLalitha Super Specialty Hospital, Guntur, IndiaHERO DMC Heart Institute, Ludhiana, IndiaHERO DMC Heart Institute, Ludhiana, IndiaBankers Heart Institute, Baroda, IndiaShree Sai Baba Hospital, Nashik, IndiaMetro Heart Institute, Faridabad, IndiaMetro Heart Institute, Faridabad, IndiaDhakkan Hospital, Rajkot, IndiaDhakkan Hospital, Rajkot, IndiaShriram Cardiac Centre, Jalandhar, IndiaWestford Hospital Group, Thrissur, IndiaFathima Hospital, Calicut, IndiaA.J. Hospital and Research Centre, Mangaluru, IndiaG.S.S. Hospital and Trauma Centre, Hubli, IndiaShri Sai Cardiac Centre, Kolhapur, IndiaLourdes Heart Institute, Cochin, IndiaObjectives: 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.http://www.sciencedirect.com/science/article/pii/S0019483216304059Biodegradable polymerCobalt–chromiumHybrid cell designSirolimus-eluting stent |
spellingShingle | 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 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 Biodegradable polymer Cobalt–chromium Hybrid cell design Sirolimus-eluting stent |
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 |
title_full | 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 |
title_fullStr | 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 |
title_full_unstemmed | 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 |
title_short | 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 |
title_sort | 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 |
topic | Biodegradable polymer Cobalt–chromium Hybrid cell design Sirolimus-eluting stent |
url | http://www.sciencedirect.com/science/article/pii/S0019483216304059 |
work_keys_str_mv | AT rajendrakumarjain oneyearoutcomesofabiomimesirolimuselutingcoronarystentsystemwithabiodegradablepolymerinallcomerscoronaryarterydiseasepatientsthemerit3study AT padmanabhachakravarthi oneyearoutcomesofabiomimesirolimuselutingcoronarystentsystemwithabiodegradablepolymerinallcomerscoronaryarterydiseasepatientsthemerit3study AT rajanshetty oneyearoutcomesofabiomimesirolimuselutingcoronarystentsystemwithabiodegradablepolymerinallcomerscoronaryarterydiseasepatientsthemerit3study AT padmakumarramchandra oneyearoutcomesofabiomimesirolimuselutingcoronarystentsystemwithabiodegradablepolymerinallcomerscoronaryarterydiseasepatientsthemerit3study AT raghavasarmapolavarapu oneyearoutcomesofabiomimesirolimuselutingcoronarystentsystemwithabiodegradablepolymerinallcomerscoronaryarterydiseasepatientsthemerit3study AT gurupreetsinghwander oneyearoutcomesofabiomimesirolimuselutingcoronarystentsystemwithabiodegradablepolymerinallcomerscoronaryarterydiseasepatientsthemerit3study AT bishavmohan oneyearoutcomesofabiomimesirolimuselutingcoronarystentsystemwithabiodegradablepolymerinallcomerscoronaryarterydiseasepatientsthemerit3study AT darshannavinchandrabanker oneyearoutcomesofabiomimesirolimuselutingcoronarystentsystemwithabiodegradablepolymerinallcomerscoronaryarterydiseasepatientsthemerit3study AT aniruddhadharmadhikari oneyearoutcomesofabiomimesirolimuselutingcoronarystentsystemwithabiodegradablepolymerinallcomerscoronaryarterydiseasepatientsthemerit3study AT shyamsundarbansal oneyearoutcomesofabiomimesirolimuselutingcoronarystentsystemwithabiodegradablepolymerinallcomerscoronaryarterydiseasepatientsthemerit3study AT neerajjain oneyearoutcomesofabiomimesirolimuselutingcoronarystentsystemwithabiodegradablepolymerinallcomerscoronaryarterydiseasepatientsthemerit3study AT dharmeshsolanki oneyearoutcomesofabiomimesirolimuselutingcoronarystentsystemwithabiodegradablepolymerinallcomerscoronaryarterydiseasepatientsthemerit3study AT jagdishdhakaan oneyearoutcomesofabiomimesirolimuselutingcoronarystentsystemwithabiodegradablepolymerinallcomerscoronaryarterydiseasepatientsthemerit3study AT vedprakashsharma oneyearoutcomesofabiomimesirolimuselutingcoronarystentsystemwithabiodegradablepolymerinallcomerscoronaryarterydiseasepatientsthemerit3study AT padhinharepmohanan oneyearoutcomesofabiomimesirolimuselutingcoronarystentsystemwithabiodegradablepolymerinallcomerscoronaryarterydiseasepatientsthemerit3study AT parayarukottayalashokan oneyearoutcomesofabiomimesirolimuselutingcoronarystentsystemwithabiodegradablepolymerinallcomerscoronaryarterydiseasepatientsthemerit3study AT bagurvenkatmanjunath oneyearoutcomesofabiomimesirolimuselutingcoronarystentsystemwithabiodegradablepolymerinallcomerscoronaryarterydiseasepatientsthemerit3study AT narendrahiregoudar oneyearoutcomesofabiomimesirolimuselutingcoronarystentsystemwithabiodegradablepolymerinallcomerscoronaryarterydiseasepatientsthemerit3study AT chandrashekarpatil oneyearoutcomesofabiomimesirolimuselutingcoronarystentsystemwithabiodegradablepolymerinallcomerscoronaryarterydiseasepatientsthemerit3study AT narasimhabalakrishnan oneyearoutcomesofabiomimesirolimuselutingcoronarystentsystemwithabiodegradablepolymerinallcomerscoronaryarterydiseasepatientsthemerit3study |