title: Twelve-month outcomes after coronary stenting with the Genous™ bio-engineered R Stent™ in diabetic patients from the e-HEALING registry.
abstract: OBJECTIVE
  We compared 12-month outcomes, regarding ischemic events, repeat intervention, and ST, between diabetic and nondiabetic patients treated with the Genous™ EPC capturing R stent™ during routine nonurgent percutaneous coronary intervention (PCI) using data from the multicenter, prospective worldwide e-HEALING registry.
  
  
  BACKGROUND
  Diabetic patients have an increased risk for restenosis and stent thrombosis (ST).
  
  
  METHODS
  In the 4,996 patient e-HEALING registry, 273 were insulin requiring diabetics (IRD), 963 were non-IRD (NIRD), and 3,703 were nondiabetics. The 12-month primary outcome was target vessel failure (TVF), defined as target vessel-related cardiac death or myocardial infarction (MI) and target vessel revascularization. Secondary outcomes were the composite of cardiac death, MI or target lesion revascularization (TLR), and individual outcomes including ST. Cumulative event rates were estimated with the Kaplan-Meier method and compared with a log-rank test.
  
  
  RESULTS
  TVF rates were respectively 13.4% in IRD, 9.0% in NIRD, and 7.9% in nondiabetics (P < 0.01). This was mainly driven by a higher mortality hazard in IRD (P < 0.001) and NIRD (P = 0.07), compared with nondiabetics. TLR rates were comparable in NIRD and nondiabetics, but significantly higher in IRD (P = 0.04). No difference was observed in ST.
  
  
  CONCLUSIONS
  The 1-year results of the Genous stent in a real-world population of diabetics show higher TVF rates in diabetics compared with nondiabetics, mainly driven by a higher mortality hazard. IRD is associated with a significant higher TLR hazard. Definite or probable ST in all diabetic patients was comparable with nondiabetics. (J Interven Cardiol 2011;24:285-294).
authors.affiliation: Department of Cardiology, Academic Medical Center, University of Amsterdam, The Netherlands.
authors.forename: Peter
authors.initials: P
authors.lastname: Damman
authors.forename: Margo
authors.initials: M
authors.lastname: Klomp
authors.forename: Marcel A
authors.initials: MA
authors.lastname: Beijk
authors.forename: Sigmund
authors.initials: S
authors.lastname: Silber
authors.forename: Manfred
authors.initials: M
authors.lastname: Grisold
authors.forename: Expedito E
authors.initials: EE
authors.lastname: Ribeiro
authors.forename: Harry
authors.initials: H
authors.lastname: Suryapranata
authors.forename: Jaroslaw
authors.initials: J
authors.lastname: Wójcik
authors.forename: Kui Hian
authors.initials: KH
authors.lastname: Sim
authors.forename: Jan Gp
authors.initials: JG
authors.lastname: Tijssen
authors.forename: Robbert J
authors.initials: RJ
authors.lastname: DE Winter
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D016022:Case-Control Studies; D003324:Coronary Artery Disease / Q000401:mortality / Q000628:therapy*; D023903:Coronary Restenosis / Q000517:prevention & control; D003328:Coronary Thrombosis / Q000209:etiology; D003922:Diabetes Mellitus, Type 1 / Q000150:complications*; D003924:Diabetes Mellitus, Type 2 / Q000150:complications*; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009204:Myocardial Revascularization; D011446:Prospective Studies; D012042:Registries; D013997:Time Factors; D017211:Treatment Failure; D016896:Treatment Outcome