title: Outcomes of patients with acute coronary syndromes who are treated with bivalirudin during percutaneous coronary intervention: an analysis from the Randomized Evaluation in PCI Linking Angiomax to Reduced Clinical Events (REPLACE-2) trial.
abstract: BACKGROUND
  The REPLACE-2 trial demonstrated that bivalirudin with provisional glycoprotein IIb/IIIa (GPIIb/IIIa) inhibition is not inferior to heparin plus GPIIb/IIIa inhibition in patients undergoing percutaneous coronary intervention. The extent to which this applies to patients with acute coronary syndromes (ACS) is unclear. Therefore, we sought to determine if bivalirudin has similar efficacy in ACS patients as compared with "stable" patients in the REPLACE-2 trial.
  
  
  METHODS
  We analyzed the outcomes of ACS patients compared with stable patients and the outcomes of ACS patients according to whether or not they had received bivalirudin, including the economic costs. The trial enrolled 1351 ACS patients (myocardial infarction within 7 days or unstable angina within 48 hours, but not on ongoing GPIIb/IIIa or heparin therapy) and 4554 stable patients.
  
  
  RESULTS
  Patients with ACS had a similar rate of death or myocardial infarction at 30 days compared to stable patients (7.2% vs 6.7%, P = .51) and death at 1 year (1.6% vs 2.2%, P = .169), but a higher rate of urgent coronary artery bypass graft at 30 days (1.0% vs 0.3%, P = .002). Patients with ACS treated with bivalirudin had a similar rate of 30-day death, myocardial infarction, or urgent revascularization compared with ACS patients treated with heparin and GPIIb/IIIa inhibitors (8.7% vs 8.0%, P = .616) and death at 1 year (1.5% vs 1.8%, P = .701), but a higher rate of revascularization at 6 months (12% vs 8.4%, P = .04). Patients with ACS treated with bivalirudin had less major bleeding than ACS patients treated with heparin and GPIIb/IIIa inhibitors, although this was not statistically significant (2.7% vs 4.5%, P = .07). Mean 30-day costs for patients with ACS were dollar 12415 for those treated with bivalirudin and dollar 12806 for those treated with heparin plus GPIIb/IIIa inhibitors (P = .022).
  
  
  CONCLUSIONS
  Bivalirudin with provisional GPIIb/IIIa inhibitor use in low-risk ACS patients (not receiving preprocedural GPIIb/IIIa blockade) appears to provide similar protection against death and myocardial infarction as the combination of heparin and GPIIb/IIIa inhibitors, although we observed a higher rate of revascularization at 6 months.
authors.affiliation: Department of Cardiovascular Medicine, Cleveland Clinic Foundation, Cleveland, OH 44195, USA.
authors.forename: Vivek
authors.initials: V
authors.lastname: Rajagopal
authors.forename: A Michael
authors.initials: AM
authors.lastname: Lincoff
authors.forename: David J
authors.initials: DJ
authors.lastname: Cohen
authors.forename: Hitinder S
authors.initials: HS
authors.lastname: Gurm
authors.forename: Tingfei
authors.initials: T
authors.lastname: Hu
authors.forename: Walter J
authors.initials: WJ
authors.lastname: Desmet
authors.forename: Neal S
authors.initials: NS
authors.lastname: Kleiman
authors.forename: John A
authors.initials: JA
authors.lastname: Bittl
authors.forename: Frederick
authors.initials: F
authors.lastname: Feit
authors.forename: Eric J
authors.initials: EJ
authors.lastname: Topol
mesh_terms: D000368:Aged; D000789:Angina, Unstable / Q000188:drug therapy / Q000191:economics / Q000628:therapy*; D015906:Angioplasty, Balloon, Coronary; D000925:Anticoagulants / Q000191:economics / Q000627:therapeutic use; D000991:Antithrombins / Q000191:economics / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D004359:Drug Therapy, Combination; D005260:Female; D006493:Heparin / Q000191:economics / Q000627:therapeutic use; D006629:Hirudins / Q000191:economics; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000188:drug therapy / Q000191:economics / Q000628:therapy*; D010446:Peptide Fragments / Q000191:economics / Q000627:therapeutic use*; D019039:Platelet Glycoprotein GPIIb-IIIa Complex / Q000037:antagonists & inhibitors / Q000191:economics; D016032:Randomized Controlled Trials as Topic; D011994:Recombinant Proteins / Q000191:economics / Q000627:therapeutic use; D013577:Syndrome; D016896:Treatment Outcome; D014481:United States
chemical_list: D000925:Anticoagulants; D000991:Antithrombins; D006629:Hirudins; D010446:Peptide Fragments; D019039:Platelet Glycoprotein GPIIb-IIIa Complex; D011994:Recombinant Proteins; D006493:Heparin; C074619:bivalirudin