Literature DB >> 24206882

Clinical outcomes with Biolimus (A9)™ eluting stent, 'BioMatrix' in diabetic patients--interim results from multicenter post market surveillance registry in India.

Ashok Seth1, Shirish Hiremath, Sameer Dani, Sunil Kapoor, R K Jain, Rajpal Abhaichand, Shailendra Trivedi, Upendra Kaul, Aruna Patil, Bhushan Khemnar, Hrishikesh Rangnekar.   

Abstract

OBJECTIVE: The objective of this registry is to establish safety and efficacy of BioMatrix, BioMatrix™-Biolimus A9™ eluting stent in diabetic population in India.
BACKGROUND: Diabetes mellitus is a major predisposing factor for coronary artery disease. Prognosis for diabetic population patients presenting with coronary artery disease who undergo coronary revascularization is inferior to non diabetics and remains an independent risk factor of restenosis, need for revascularization, and overall mortality. Stent thrombosis is a potential complication of first generation, permanent polymer drug-eluting stents. Biodegradable polymer is a good relief in this era and its utility in diabetic patients will be a major advantage for them.
METHODS: 334 patients with diabetes mellitus and requiring angioplasty, implanted with BioMatrix stent were followed at 1, 6, 12 and 24 months who entered in a multicenter registry in India. We analyzed the incidence of major adverse cardiac events (MACE) and stent thrombosis (ST) at 1, 6, 12 and 24 months.
RESULTS: The mean age was 58.71 ± 9.2 years, 81% were males, comorbidity index was 1.6 ± 1.02, and 59.1% presented with acute coronary syndrome. The incidence of adverse event rates was: MACE 1.27%. There were no incidences of myocardial infarction (MI) and target vessel revascularization (TVR). Definite stent thrombosis occurred only in 2 patients.
CONCLUSION: In this registry of diabetic population treated with BioMatrixTM-Biolimus A9TM eluting stent (BioMatrix), the reported incidence of MACE and ST were much lower than previously published results. The 1- and 2-year follow-up result supports favorable clinical outcomes of using BioMatrix stents as a suitable alternative to contemporary DES available during PCI in diabetic patients.
Copyright © 2013 Cardiological Society of India. Published by Elsevier B.V. All rights reserved.

Entities:  

Keywords:  BES; BioMatrix; Diabetes; MACE; Stent thrombosis

Mesh:

Substances:

Year:  2013        PMID: 24206882      PMCID: PMC3861264          DOI: 10.1016/j.ihj.2013.08.030

Source DB:  PubMed          Journal:  Indian Heart J        ISSN: 0019-4832


  34 in total

1.  Biolimus-eluting stent with biodegradable polymer versus sirolimus-eluting stent with durable polymer for coronary revascularisation (LEADERS): a randomised non-inferiority trial.

Authors:  Stephan Windecker; Patrick W Serruys; Simon Wandel; Pawel Buszman; Stanislaw Trznadel; Axel Linke; Karsten Lenk; Thomas Ischinger; Volker Klauss; Franz Eberli; Roberto Corti; William Wijns; Marie-Claude Morice; Carlo di Mario; Simon Davies; Robert-Jan van Geuns; Pedro Eerdmans; Gerrit-Anne van Es; Bernhard Meier; Peter Jüni
Journal:  Lancet       Date:  2008-08-31       Impact factor: 79.321

2.  Incidence and correlates of drug-eluting stent thrombosis in routine clinical practice. 4-year results from a large 2-institutional cohort study.

Authors:  Peter Wenaweser; Joost Daemen; Marcel Zwahlen; Ron van Domburg; Peter Jüni; Sophia Vaina; Gerrit Hellige; Keiichi Tsuchida; Cyrill Morger; Eric Boersma; Neville Kukreja; Bernhard Meier; Patrick W Serruys; Stephan Windecker
Journal:  J Am Coll Cardiol       Date:  2008-09-30       Impact factor: 24.094

3.  Randomized comparison of sirolimus-eluting stent versus standard stent for percutaneous coronary revascularization in diabetic patients: the diabetes and sirolimus-eluting stent (DIABETES) trial.

Authors:  Manel Sabaté; Pilar Jiménez-Quevedo; Dominick J Angiolillo; Joan Antoni Gómez-Hospital; Fernando Alfonso; Rosana Hernández-Antolín; Javier Goicolea; Camino Bañuelos; Javier Escaned; Raúl Moreno; Cristina Fernández; Francisco Fernández-Avilés; Carlos Macaya
Journal:  Circulation       Date:  2005-10-04       Impact factor: 29.690

4.  Vessel size and outcome after coronary drug-eluting stent placement: results from a large cohort of patients treated with sirolimus- or paclitaxel-eluting stents.

Authors:  Shpend Elezi; Alban Dibra; Julinda Mehilli; Jürgen Pache; Rainer Wessely; Albert Schömig; Adnan Kastrati
Journal:  J Am Coll Cardiol       Date:  2006-09-12       Impact factor: 24.094

5.  The Coronary Artery Revascularisation in Diabetes (CARDia) trial: background, aims, and design.

Authors:  A Kapur; I S Malik; J P Bagger; J R Anderson; J S Kooner; M Thomas; P Punjabi; J Mayet; T Millane; J Goedicke; K Jamrozik; M A de Belder; R J Hall; K J Beatt
Journal:  Am Heart J       Date:  2005-01       Impact factor: 4.749

6.  Sirolimus-eluting vs uncoated stents for prevention of restenosis in small coronary arteries: a randomized trial.

Authors:  Diego Ardissino; Claudio Cavallini; Ezio Bramucci; Ciro Indolfi; Antonio Marzocchi; Antonio Manari; Giulia Angeloni; Giuseppe Carosio; Erminio Bonizzoni; Stefania Colusso; Monica Repetto; Piera Angelica Merlini
Journal:  JAMA       Date:  2004-12-08       Impact factor: 56.272

7.  Early and late coronary stent thrombosis of sirolimus-eluting and paclitaxel-eluting stents in routine clinical practice: data from a large two-institutional cohort study.

Authors:  Joost Daemen; Peter Wenaweser; Keiichi Tsuchida; Linda Abrecht; Sophia Vaina; Cyrill Morger; Neville Kukreja; Peter Jüni; Georgios Sianos; Gerrit Hellige; Ron T van Domburg; Otto M Hess; Eric Boersma; Bernhard Meier; Stephan Windecker; Patrick W Serruys
Journal:  Lancet       Date:  2007-02-24       Impact factor: 79.321

8.  Paclitaxel-eluting or sirolimus-eluting stents to prevent restenosis in diabetic patients.

Authors:  Alban Dibra; Adnan Kastrati; Julinda Mehilli; Jürgen Pache; Helmut Schühlen; Nicolas von Beckerath; Kurt Ulm; Rainer Wessely; Josef Dirschinger; Albert Schömig
Journal:  N Engl J Med       Date:  2005-08-16       Impact factor: 91.245

9.  Sirolimus eluting stent (Cypher) in patients with diabetes mellitus: results from the German Cypher Stent Registry.

Authors:  Frank D Weber; Henrik Schneider; Marcus Wiemer; Thomas Pfannebecker; Ulrich Tebbe; Christian W Hamm; Jochen Senges; Steffen Schneider; Christoph A Nienaber
Journal:  Clin Res Cardiol       Date:  2007-12-06       Impact factor: 5.460

10.  Randomized trial of three rapamycin-eluting stents with different coating strategies for the reduction of coronary restenosis.

Authors:  Julinda Mehilli; Robert A Byrne; Anna Wieczorek; Raisuke Iijima; Stefanie Schulz; Olga Bruskina; Jürgen Pache; Rainer Wessely; Albert Schömig; Adnan Kastrati
Journal:  Eur Heart J       Date:  2008-06-11       Impact factor: 29.983

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  2 in total

1.  Assessment of utility values and QALYs after primary PCI with DP-Xience and BP-Biomatrix stents.

Authors:  Salma Bibi; Amjad Khan; Asif Nadeem; Saima Mushtaq; Gul Majid Khan
Journal:  PLoS One       Date:  2021-06-17       Impact factor: 3.240

2.  Two-year safety and efficacy of Indigenous Abluminus Sirolimus Eluting Stent. Does it differ amongst diabetics? - Data from en-ABLe- REGISTRY.

Authors:  Kamal Sharma; Sameer Dani; Devang Desai; Prathap Kumar; Nirav Bhalani; Apurva Vasavada; Rutvik Trivedi
Journal:  J Cardiovasc Thorac Res       Date:  2021-05-19
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