One-year clinical outcomes of BioMatrix™-Biolimus A9™ eluting stent: The e-BioMatrix multicenter post marketing surveillance registry in India
Objective: The e-BioMatrix is a post marketing multicenter registry with an objective to evaluate the 2 year clinical safety and efficacy outcomes in patients treated with BioMatrix™ - Biolimus A9™ (BA9™) drug eluting stents (DES). Background: Drug-eluting stents still have late-stage disadvantages...
| Main Authors: | , , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Elsevier
2013-09-01
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| Series: | Indian Heart Journal |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S0019483213002848 |
| _version_ | 1819000183560601600 |
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| author | Ashwin B. Mehta Praveen Chandra Jamshed Dalal Prabhakar Shetty Devang Desai K. Chocklingam Jayesh Prajapati Pramod Kumar Vilas Magarkar Apurva Vasawada B.K. Goyal Viveka Kumar V. Suryaprakash Rao Ramesh Babu Pritesh Parikh Upendra Kaul Aruna Patil Tushar Mhetre Hrishikesh Rangnekar |
| author_facet | Ashwin B. Mehta Praveen Chandra Jamshed Dalal Prabhakar Shetty Devang Desai K. Chocklingam Jayesh Prajapati Pramod Kumar Vilas Magarkar Apurva Vasawada B.K. Goyal Viveka Kumar V. Suryaprakash Rao Ramesh Babu Pritesh Parikh Upendra Kaul Aruna Patil Tushar Mhetre Hrishikesh Rangnekar |
| author_sort | Ashwin B. Mehta |
| collection | DOAJ |
| description | Objective: The e-BioMatrix is a post marketing multicenter registry with an objective to evaluate the 2 year clinical safety and efficacy outcomes in patients treated with BioMatrix™ - Biolimus A9™ (BA9™) drug eluting stents (DES).
Background: Drug-eluting stents still have late-stage disadvantages that might be attributable to the permanent polymer. BioMatrix a new generation DES containing anti-proliferative drug Biolimus A9™ incorporating a biodegradable abluminal coating that leaves a polymer-free stent after drug release enhancing strut coverage while preventing neointimal hyperplasia.
Methods: This interim analysis consists of a total of 1189 patients with 1418 lesions treated with BioMatrix stent who entered this multicenter registry in India. We analyzed the incidence of major adverse cardiac events (MACE) and stent thrombosis (ST) at 1, 6, and 12 months with an extended follow-up of 2 years. Recommended antiplatelet regimen included clopidogrel and aspirin for 12 months.
Results: The mean age was 57.6 ± 10.9 years, 81.8% were males, comorbidity index was 1.20 ± 1.33, 68% presented with acute coronary syndrome, 49% had hypertension and 40.8% had diabetes mellitus. One-year clinical follow-up was completed in 987 patients at the time of interim analysis. The incidence of MACE is 0.45 for 1544 person-year follow-up. There were only 03 cases of ST (01 late ST) reported during this time.
Conclusion: This registry demonstrates excellent one-year clinical safety and efficacy of BioMatrix stents. The 1-year result shows that BioMatrix stent may be a suitable alternative as compared to contemporary DESs which are currently available in the market for simple as well complex disease. |
| first_indexed | 2024-12-20T22:29:16Z |
| format | Article |
| id | doaj.art-95e1048147dd4616a6fa8c6135c67376 |
| institution | Directory Open Access Journal |
| issn | 0019-4832 |
| language | English |
| last_indexed | 2024-12-20T22:29:16Z |
| publishDate | 2013-09-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Indian Heart Journal |
| spelling | doaj.art-95e1048147dd4616a6fa8c6135c673762022-12-21T19:24:45ZengElsevierIndian Heart Journal0019-48322013-09-0165559359910.1016/j.ihj.2013.08.031One-year clinical outcomes of BioMatrix™-Biolimus A9™ eluting stent: The e-BioMatrix multicenter post marketing surveillance registry in IndiaAshwin B. Mehta0Praveen Chandra1Jamshed Dalal2Prabhakar Shetty3Devang Desai4K. Chocklingam5Jayesh Prajapati6Pramod Kumar7Vilas Magarkar8Apurva Vasawada9B.K. Goyal10Viveka Kumar11V. Suryaprakash Rao12Ramesh Babu13Pritesh Parikh14Upendra Kaul15Aruna Patil16Tushar Mhetre17Hrishikesh Rangnekar18Jaslok Hospital, Mumbai, IndiaMedanta – The Medicity Hospital, Gurgaon, IndiaKokilaben Dhirubhai Ambani Hospital, Mumbai, IndiaColumbia Asia Referral Hospital, Bangalore, IndiaMahavir Heart Institute, Surat, IndiaKovai Medical Centre, Coimbatore, IndiaApollo Hospital, Ahmedabad, IndiaKamineni Hospital, Hyderabad, IndiaDhoot Hospital, Aurangabad, IndiaCare Hospital, Surat, IndiaBombay Hospital, Mumbai, IndiaMax Devki Devi Heart Institute, New Delhi, IndiaGlobal Hospital, Hyderabad, IndiaDr Ramesh Cardiac Hospital, Vijayawada, IndiaCare Hospital, Surat, IndiaEscorts Heart Institute, New Delhi, IndiaConsultant Biostatistician, IndiaBiosensors International, IndiaBiosensors International, IndiaObjective: The e-BioMatrix is a post marketing multicenter registry with an objective to evaluate the 2 year clinical safety and efficacy outcomes in patients treated with BioMatrix™ - Biolimus A9™ (BA9™) drug eluting stents (DES). Background: Drug-eluting stents still have late-stage disadvantages that might be attributable to the permanent polymer. BioMatrix a new generation DES containing anti-proliferative drug Biolimus A9™ incorporating a biodegradable abluminal coating that leaves a polymer-free stent after drug release enhancing strut coverage while preventing neointimal hyperplasia. Methods: This interim analysis consists of a total of 1189 patients with 1418 lesions treated with BioMatrix stent who entered this multicenter registry in India. We analyzed the incidence of major adverse cardiac events (MACE) and stent thrombosis (ST) at 1, 6, and 12 months with an extended follow-up of 2 years. Recommended antiplatelet regimen included clopidogrel and aspirin for 12 months. Results: The mean age was 57.6 ± 10.9 years, 81.8% were males, comorbidity index was 1.20 ± 1.33, 68% presented with acute coronary syndrome, 49% had hypertension and 40.8% had diabetes mellitus. One-year clinical follow-up was completed in 987 patients at the time of interim analysis. The incidence of MACE is 0.45 for 1544 person-year follow-up. There were only 03 cases of ST (01 late ST) reported during this time. Conclusion: This registry demonstrates excellent one-year clinical safety and efficacy of BioMatrix stents. The 1-year result shows that BioMatrix stent may be a suitable alternative as compared to contemporary DESs which are currently available in the market for simple as well complex disease.http://www.sciencedirect.com/science/article/pii/S0019483213002848BioMatrixBESBiodegradableMACEStent thrombosis |
| spellingShingle | Ashwin B. Mehta Praveen Chandra Jamshed Dalal Prabhakar Shetty Devang Desai K. Chocklingam Jayesh Prajapati Pramod Kumar Vilas Magarkar Apurva Vasawada B.K. Goyal Viveka Kumar V. Suryaprakash Rao Ramesh Babu Pritesh Parikh Upendra Kaul Aruna Patil Tushar Mhetre Hrishikesh Rangnekar One-year clinical outcomes of BioMatrix™-Biolimus A9™ eluting stent: The e-BioMatrix multicenter post marketing surveillance registry in India Indian Heart Journal BioMatrix BES Biodegradable MACE Stent thrombosis |
| title | One-year clinical outcomes of BioMatrix™-Biolimus A9™ eluting stent: The e-BioMatrix multicenter post marketing surveillance registry in India |
| title_full | One-year clinical outcomes of BioMatrix™-Biolimus A9™ eluting stent: The e-BioMatrix multicenter post marketing surveillance registry in India |
| title_fullStr | One-year clinical outcomes of BioMatrix™-Biolimus A9™ eluting stent: The e-BioMatrix multicenter post marketing surveillance registry in India |
| title_full_unstemmed | One-year clinical outcomes of BioMatrix™-Biolimus A9™ eluting stent: The e-BioMatrix multicenter post marketing surveillance registry in India |
| title_short | One-year clinical outcomes of BioMatrix™-Biolimus A9™ eluting stent: The e-BioMatrix multicenter post marketing surveillance registry in India |
| title_sort | one year clinical outcomes of biomatrix™ biolimus a9™ eluting stent the e biomatrix multicenter post marketing surveillance registry in india |
| topic | BioMatrix BES Biodegradable MACE Stent thrombosis |
| url | http://www.sciencedirect.com/science/article/pii/S0019483213002848 |
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