title: Economic evaluation of bivalirudin with or without glycoprotein IIb/IIIa inhibition versus heparin with routine glycoprotein IIb/IIIa inhibition for early invasive management of acute coronary syndromes.
abstract: OBJECTIVE
  The aim of this study was to determine the economic impact of several anticoagulation strategies for moderate- and high-risk non-ST-segment elevation acute coronary syndrome (NSTE-ACS) patients managed invasively.
  
  
  BACKGROUND
  The ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) trial demonstrated that bivalirudin monotherapy yields similar rates of ischemic complications and less bleeding than regimens incorporating glycoprotein IIb/IIIa receptor inhibitors (GPI) for moderate- and high-risk NSTE-ACS.
  
  
  METHODS
  In ACUITY, 7,851 U.S. patients were randomized to: 1) heparin (unfractionated or enoxaparin) + GPI; 2) bivalirudin + GPI; or 3) bivalirudin monotherapy. Patients assigned to GPI were also randomized to upstream GPI before catheterization or selective GPI only with percutaneous coronary intervention. Resource use data were collected prospectively through 30-day follow-up. Costs were estimated with standard methods including resource-based accounting, hospital billing data, and the Medicare fee schedule.
  
  
  RESULTS
  At 30 days, ischemic events were similar for all groups. Major bleeding was reduced with bivalirudin monotherapy compared with heparin + GPI or bivalirudin + GPI (p < 0.001). Length of stay was lowest with bivalirudin monotherapy or bivalirudin + catheterization laboratory GPI (p = 0.02). Despite higher drug costs, aggregate hospital stay costs were lowest with bivalirudin monotherapy (mean difference range: $184 to $1,081, p < 0.001 for overall comparison) and at 30 days (mean difference range: $123 to $938, p = 0.005). Regression modeling demonstrated that hospital savings were primarily due to less major and minor bleeding with bivalirudin ($8,658/event and $2,282/event, respectively).
  
  
  CONCLUSIONS
  Among U.S. patients in the ACUITY trial, bivalirudin monotherapy compared with heparin + GPI resulted in similar protection from ischemic events, reduced bleeding, and shorter length of stay. Despite higher drug costs, aggregate hospital and 30-day costs were lowest with bivalirudin monotherapy. Thus bivalirudin monotherapy seems to be an economically attractive alternative to heparin + GPI for patients with moderate- and high-risk NSTE-ACS. (Comparison of Angiomax Versus Heparin in Acute Coronary Syndromes [ACS]; NCT00093158).
authors.affiliation: Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts 02115, USA. dpinto@bidmc.harvard.edu
authors.forename: Duane S
authors.initials: DS
authors.lastname: Pinto
authors.forename: Gregg W
authors.initials: GW
authors.lastname: Stone
authors.forename: Chunxue
authors.initials: C
authors.lastname: Shi
authors.forename: Elizabeth S
authors.initials: ES
authors.lastname: Dunn
authors.forename: Matthew R
authors.initials: MR
authors.lastname: Reynolds
authors.forename: Meghan
authors.initials: M
authors.lastname: York
authors.forename: Joshua
authors.initials: J
authors.lastname: Walczak
authors.forename: Ronna H
authors.initials: RH
authors.lastname: Berezin
authors.forename: Roxana
authors.initials: R
authors.lastname: Mehran
authors.forename: Brent T
authors.initials: BT
authors.lastname: McLaurin
authors.forename: David A
authors.initials: DA
authors.lastname: Cox
authors.forename: E Magnus
authors.initials: EM
authors.lastname: Ohman
authors.forename: A Michael
authors.initials: AM
authors.lastname: Lincoff
authors.forename: David J
authors.initials: DJ
authors.lastname: Cohen
mesh_terms: D054058:Acute Coronary Syndrome / Q000188:drug therapy* / Q000191:economics*; D015906:Angioplasty, Balloon, Coronary; D000925:Anticoagulants / Q000191:economics* / Q000627:therapeutic use*; D001026:Coronary Artery Bypass; D004359:Drug Therapy, Combination; D005260:Female; D017048:Health Care Costs; D006493:Heparin / Q000191:economics* / Q000627:therapeutic use*; D006495:Heparin, Low-Molecular-Weight / Q000191:economics / Q000627:therapeutic use; D006629:Hirudins / 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*; D011446:Prospective Studies; D011994:Recombinant Proteins / Q000191:economics / Q000627:therapeutic use; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States
chemical_list: D000925:Anticoagulants; D006495:Heparin, Low-Molecular-Weight; D006629:Hirudins; D010446:Peptide Fragments; D019039:Platelet Glycoprotein GPIIb-IIIa Complex; D011994:Recombinant Proteins; D006493:Heparin; C074619:bivalirudin