title: Economic evaluation of bivalirudin with provisional glycoprotein IIB/IIIA inhibition versus heparin with routine glycoprotein IIB/IIIA inhibition for percutaneous coronary intervention: results from the REPLACE-2 trial.
abstract: OBJECTIVE
  The purpose of this study was to compare the cost of percutaneous coronary intervention (PCI) using bivalirudin with provisional platelet glycoprotein (GP) IIb/IIIa inhibition with that of heparin + routine GP IIb/IIIa inhibition.
  
  
  BACKGROUND
  Although GP IIb/IIIa inhibition has been shown to reduce ischemic complications in a broad range of patients undergoing PCI, many patients currently do not receive such therapy because of concerns about bleeding complications or cost. Recently, bivalirudin with provisional GP IIb/IIIa inhibition has been validated as an alternative to heparin + routine GP IIb/IIIa inhibition for patients undergoing PCI. However, the cost-effectiveness of this novel strategy is unknown.
  
  
  METHODS
  In the Randomized Evaluation in PCI Linking Angiomax to Reduced Clinical Events (REPLACE)-2 trial, 4,651 U.S. patients undergoing non-emergent PCI were randomized to receive bivalirudin with provisional GP IIb/IIIa (n = 2,319) versus heparin + routine GP IIb/IIIa (n = 2,332). Resource utilization data were collected prospectively through 30-day follow-up on all U.S. patients. Medical care costs were estimated using standard methods including bottom-up accounting (for procedural costs), the Medicare fee schedule (for physician services), hospital billing data (for 2,821 of 4,862 admissions), and regression-based approaches for the remaining hospitalizations.
  
  
  RESULTS
  Among the bivalirudin group, 7.7% required provisional GP IIb/IIIa. Thirty-day ischemic outcomes including death or myocardial infarction were similar for the bivalirudin and GP IIb/IIIa groups, but bivalirudin resulted in lower rates of major bleeding (2.8% vs. 4.5%, p = 0.002) and minor bleeding (15.1% vs. 28.1%, p < 0.001). Compared with routine GP IIb/IIIa, in-hospital and 30-day costs were reduced by $405 (95% confidence interval [CI] $37 to $773) and $374 (95% CI $61 to $688) per patient with bivalirudin (p < 0.001 for both). Regression modeling demonstrated that, in addition to the costs of the anticoagulants themselves, hospital savings were due primarily to reductions in major bleeding (cost savings = $107/patient), minor bleeding ($52/patient), and thrombocytopenia ($47/patient).
  
  
  CONCLUSIONS
  Compared with heparin + routine GP IIb/IIIa inhibition, bivalirudin + provisional GP IIb/IIIa inhibition resulted in similar acute ischemic events and cost savings of $375 to $400/patient depending on the analytic perspective.
authors.affiliation: Cardiovascular Division, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA. dcohen@caregroup.harvard.edu
authors.forename: David J
authors.initials: DJ
authors.lastname: Cohen
authors.forename: A Michael
authors.initials: AM
authors.lastname: Lincoff
authors.forename: Tara A
authors.initials: TA
authors.lastname: Lavelle
authors.forename: Huei-Ling
authors.initials: HL
authors.lastname: Chen
authors.forename: Ameet
authors.initials: A
authors.lastname: Bakhai
authors.forename: Ronna H
authors.initials: RH
authors.lastname: Berezin
authors.forename: Daniel
authors.initials: D
authors.lastname: Jackman
authors.forename: Ian J
authors.initials: IJ
authors.lastname: Sarembock
authors.forename: Eric J
authors.initials: EJ
authors.lastname: Topol
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000191:economics*; D000925:Anticoagulants / Q000191:economics* / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D003327:Coronary Disease / Q000191:economics* / Q000628:therapy*; D003365:Costs and Cost Analysis; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006493:Heparin / Q000191:economics* / Q000627:therapeutic use*; D006629:Hirudins / Q000031:analogs & derivatives* / Q000191:economics*; D006760:Hospitalization / Q000191:economics; D006801:Humans; D008297:Male; D008875:Middle Aged; D010446:Peptide Fragments / Q000191:economics* / Q000627:therapeutic use*; D019039:Platelet Glycoprotein GPIIb-IIIa Complex / Q000037:antagonists & inhibitors* / Q000191:economics / Q000627:therapeutic use*; D011994:Recombinant Proteins / Q000191:economics* / Q000627:therapeutic use*; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology
chemical_list: D000925:Anticoagulants; D006629:Hirudins; D010446:Peptide Fragments; D019039:Platelet Glycoprotein GPIIb-IIIa Complex; D011994:Recombinant Proteins; D006493:Heparin; C074619:bivalirudin