title: One-year clinical outcomes of BioMatrix™-Biolimus A9™ eluting stent: the e-BioMatrix multicenter post marketing surveillance registry in India.
abstract: 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.
  
  
  CONCLUSIONS
  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.affiliation: Jaslok Hospital, Mumbai, India.
authors.forename: Ashwin B
authors.initials: AB
authors.lastname: Mehta
authors.forename: Praveen
authors.initials: P
authors.lastname: Chandra
authors.forename: Jamshed
authors.initials: J
authors.lastname: Dalal
authors.forename: Prabhakar
authors.initials: P
authors.lastname: Shetty
authors.forename: Devang
authors.initials: D
authors.lastname: Desai
authors.forename: K
authors.initials: K
authors.lastname: Chocklingam
authors.forename: Jayesh
authors.initials: J
authors.lastname: Prajapati
authors.forename: Pramod
authors.initials: P
authors.lastname: Kumar
authors.forename: Vilas
authors.initials: V
authors.lastname: Magarkar
authors.forename: Apurva
authors.initials: A
authors.lastname: Vasawada
authors.forename: B K
authors.initials: BK
authors.lastname: Goyal
authors.forename: Viveka
authors.initials: V
authors.lastname: Kumar
authors.forename: V Suryaprakash
authors.initials: VS
authors.lastname: Rao
authors.forename: Ramesh
authors.initials: R
authors.lastname: Babu
authors.forename: Pritesh
authors.initials: P
authors.lastname: Parikh
authors.forename: Upendra
authors.initials: U
authors.lastname: Kaul
authors.forename: Aruna
authors.initials: A
authors.lastname: Patil
authors.forename: Tushar
authors.initials: T
authors.lastname: Mhetre
authors.forename: Hrishikesh
authors.initials: H
authors.lastname: Rangnekar
mesh_terms: D020341:Absorbable Implants; D054058:Acute Coronary Syndrome / Q000453:epidemiology; D000367:Age Factors; D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D023921:Coronary Stenosis / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D054855:Drug-Eluting Stents; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007194:India; D008297:Male; D008875:Middle Aged; D011358:Product Surveillance, Postmarketing; D011475:Prosthesis Failure; D011859:Radiography; D012042:Registries; D018570:Risk Assessment; D012737:Sex Factors; D020123:Sirolimus / Q000031:analogs & derivatives* / Q000494:pharmacology; D015996:Survival Rate; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: C518022:umirolimus; D020123:Sirolimus
keywords: BES; BioMatrix; Biodegradable; MACE; Stent thrombosis