title: Clinical outcomes with Biolimus (A9)™ eluting stent, 'BioMatrix' in diabetic patients--interim results from multicenter post market surveillance registry in India.
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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Escort Heart Institute, New Delhi, India.
authors.forename: Ashok
authors.initials: A
authors.lastname: Seth
authors.forename: Shirish
authors.initials: S
authors.lastname: Hiremath
authors.forename: Sameer
authors.initials: S
authors.lastname: Dani
authors.forename: Sunil
authors.initials: S
authors.lastname: Kapoor
authors.forename: R K
authors.initials: RK
authors.lastname: Jain
authors.forename: Rajpal
authors.initials: R
authors.lastname: Abhaichand
authors.forename: Shailendra
authors.initials: S
authors.lastname: Trivedi
authors.forename: Upendra
authors.initials: U
authors.lastname: Kaul
authors.forename: Aruna
authors.initials: A
authors.lastname: Patil
authors.forename: Bhushan
authors.initials: B
authors.lastname: Khemnar
authors.forename: Hrishikesh
authors.initials: H
authors.lastname: Rangnekar
mesh_terms: D020341:Absorbable Implants; D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000295:instrumentation* / Q000379:methods / Q000401:mortality; D017023:Coronary Angiography / Q000379:methods; D023921:Coronary Stenosis / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D003922:Diabetes Mellitus, Type 1 / Q000175:diagnosis / Q000401:mortality / Q000628:therapy; D003924:Diabetes Mellitus, Type 2 / Q000175:diagnosis / Q000401:mortality / Q000628:therapy; D003925:Diabetic Angiopathies / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D054855:Drug-Eluting Stents; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007194:India; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D011358:Product Surveillance, Postmarketing; D011446:Prospective Studies; D011474:Prosthesis Design; D011475:Prosthesis Failure; D012042:Registries; D018570:Risk Assessment; D012720:Severity of Illness Index; 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; Diabetes; MACE; Stent thrombosis