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.
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.
Authors: Patrick W Serruys; Sigmund Silber; Scot Garg; Robert Jan van Geuns; Gert Richardt; Pawel E Buszman; Henning Kelbaek; Adrianus Johannes van Boven; Sjoerd H Hofma; Axel Linke; Volker Klauss; William Wijns; Carlos Macaya; Philippe Garot; Carlo DiMario; Ganesh Manoharan; Ran Kornowski; Thomas Ischinger; Antonio Bartorelli; Jacintha Ronden; Marco Bressers; Pierre Gobbens; Manuela Negoita; Frank van Leeuwen; Stephan Windecker Journal: N Engl J Med Date: 2010-06-16 Impact factor: 91.245
Authors: Pramod K Kuchulakanti; William W Chu; Rebecca Torguson; Patrick Ohlmann; Seung-Woon Rha; Leonardo C Clavijo; Sang-Wook Kim; Ahn Bui; Natalie Gevorkian; Zhenyi Xue; Kimberly Smith; Jana Fournadjieva; William O Suddath; Lowell F Satler; Augusto D Pichard; Kenneth M Kent; Ron Waksman Journal: Circulation Date: 2006-02-20 Impact factor: 29.690
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
Authors: Gregg W Stone; Stephen G Ellis; David A Cox; James Hermiller; Charles O'Shaughnessy; James Tift Mann; Mark Turco; Ronald Caputo; Patrick Bergin; Joel Greenberg; Jeffrey J Popma; Mary E Russell Journal: N Engl J Med Date: 2004-01-15 Impact factor: 91.245
Authors: W J van der Giessen; A M Lincoff; R S Schwartz; H M van Beusekom; P W Serruys; D R Holmes; S G Ellis; E J Topol Journal: Circulation Date: 1996-10-01 Impact factor: 29.690
Authors: J Stephen Mikita; Jules Mitchel; Nicolle M Gatto; John Laschinger; James E Tcheng; Emily P Zeitler; Arlene S Swern; E Dawn Flick; Christopher Dowd; Theodore Lystig; Sara B Calvert Journal: Ther Innov Regul Sci Date: 2020-06-22 Impact factor: 1.778