title: Use of bivalirudin during percutaneous coronary intervention in patients with diabetes mellitus: an analysis from the randomized evaluation in percutaneous coronary intervention linking angiomax to reduced clinical events (REPLACE)-2 trial.
abstract: OBJECTIVE
  The objective of this study was to confirm that the efficacy and safety of percutaneous coronary intervention (PCI) in diabetic patients are not compromised by a bivalirudin-based antithrombotic strategy.
  
  
  BACKGROUND
  Previous studies have shown a survival benefit with use of platelet glycoprotein (GP) IIb/IIIa inhibitors in diabetic patients undergoing PCI. The Randomized Evaluation in Percutaneous Coronary Intervention Linking Angiomax to Reduced Clinical Events (REPLACE)-2 trial showed the non-inferiority of a strategy of bivalirudin with provisional GP IIb/IIIa inhibition compared with routine GP IIb/IIIa inhibition. The relative efficacy of these two strategies in diabetic patients has not been studied.
  
  
  METHODS
  We evaluated the diabetic patients enrolled in the REPLACE-2 trial to assess the impact of these antithrombotic strategies on the short- and long-term outcome after PCI.
  
  
  RESULTS
  The REPLACE-2 trial enrolled 1,624 diabetic patients and 4,368 non-diabetic patients. Compared with non-diabetic patients, diabetic patients had similar short-term outcome but higher mortality at 1 year (3.06% vs. 1.85%, p = 0.004). There was no difference in short-term or long-term ischemic events among the diabetic patients randomized to the two arms. Specifically, the 1-year mortality rate was non-significantly lower in the bivalirudin arm, suggesting no differential survival impact of the two strategies (2.3% vs. 3.9%). There was less minor bleeding in the bivalirudin arm in diabetic patients (12.6% vs. 24.4%, p < 0.001), whereas no difference was seen in the incidence of major bleeding (3.0% vs. 3.3%, p = 0.69).
  
  
  CONCLUSIONS
  Compared with routine GP IIb/IIIa inhibition, the use of bivalirudin with provisional GP IIb/IIIa inhibitors in diabetic patients is associated with no differences in clinical outcomes at 30 days, a trend toward lesser mortality at 1 year, and a reduction in minor bleeding.
authors.affiliation: Department of Cardiovascular Medicine, Cleveland Clinic Foundation, 9500 Euclid Avenue, Cleveland, OH 44195, USA.
authors.forename: Hitinder S
authors.initials: HS
authors.lastname: Gurm
authors.forename: Ian J
authors.initials: IJ
authors.lastname: Sarembock
authors.forename: Dean J
authors.initials: DJ
authors.lastname: Kereiakes
authors.forename: John J
authors.initials: JJ
authors.lastname: Young
authors.forename: Robert A
authors.initials: RA
authors.lastname: Harrington
authors.forename: Neal
authors.initials: N
authors.lastname: Kleiman
authors.forename: Frederick
authors.initials: F
authors.lastname: Feit
authors.forename: Kathy
authors.initials: K
authors.lastname: Wolski
authors.forename: John A
authors.initials: JA
authors.lastname: Bittl
authors.forename: Robert
authors.initials: R
authors.lastname: Wilcox
authors.forename: Eric J
authors.initials: EJ
authors.lastname: Topol
authors.forename: A Michael
authors.initials: AM
authors.lastname: Lincoff
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D000925:Anticoagulants / Q000627:therapeutic use*; D003324:Coronary Artery Disease / Q000209:etiology / Q000628:therapy*; D003924:Diabetes Mellitus, Type 2 / Q000150:complications*; D004311:Double-Blind Method; D005260:Female; D006493:Heparin / Q000627:therapeutic use; D006629:Hirudins; D006801:Humans; D008297:Male; D008875:Middle Aged; D010446:Peptide Fragments / Q000627:therapeutic use*; D019039:Platelet Glycoprotein GPIIb-IIIa Complex / Q000037:antagonists & inhibitors*; D011994:Recombinant Proteins / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000925:Anticoagulants; D006629:Hirudins; D010446:Peptide Fragments; D019039:Platelet Glycoprotein GPIIb-IIIa Complex; D011994:Recombinant Proteins; D006493:Heparin; C074619:bivalirudin