title: Safety and efficacy of bivalirudin with and without glycoprotein IIb/IIIa inhibitors in patients with acute coronary syndromes undergoing percutaneous coronary intervention 1-year results from the ACUITY (Acute Catheterization and Urgent Intervention Triage strategY) trial.
abstract: OBJECTIVE
  This study was designed to determine the impact of bivalirudin on 1-year outcomes in acute coronary syndrome (ACS) patients undergoing percutaneous coronary intervention (PCI).
  
  
  BACKGROUND
  The ACUITY (Acute Catheterization and Urgent Intervention Triage strategY) trial demonstrated that in moderate- and high-risk ACS patients undergoing PCI, bivalirudin alone compared to unfractionated heparin (UFH) or enoxaparin plus a glycoprotein (GP) IIb/IIIa inhibitor resulted in less major bleeding and similar ischemic outcomes at 30 days. The impact of bivalirudin on 1-year outcomes in ACS patients undergoing PCI is unknown.
  
  
  METHODS
  In the ACUITY trial, 13,819 patients were enrolled, and 7,789 (56.4%) patients had PCI. Composite ischemia (death, myocardial infarction, or unplanned revascularization) and mortality at 1 year were assessed.
  
  
  RESULTS
  Among patients undergoing PCI, 2,561, 2,609, and 2,619 were randomized to UFH or enoxaparin plus a GP IIb/IIIa inhibitor, bivalirudin plus a GP IIb/IIIa inhibitor, and bivalirudin monotherapy, respectively. At 1 year, there were no differences in composite ischemia (17.8% vs. 19.4% vs. 19.2%, p = NS) or mortality (3.2% vs. 3.3% vs. 3.1%, p = NS) among the 3 groups, respectively.
  
  
  CONCLUSIONS
  Bivalirudin compared with UFH or enoxaparin plus a GP IIb/IIIa inhibitor results in similar rates of composite ischemia and mortality at 1 year in moderate- and high-risk ACS patients undergoing PCI.
authors.affiliation: Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand. HarveyW@adhb.govt.nz
authors.forename: Harvey D
authors.initials: HD
authors.lastname: White
authors.forename: E Magnus
authors.initials: EM
authors.lastname: Ohman
authors.forename: A Michael
authors.initials: AM
authors.lastname: Lincoff
authors.forename: Michel E
authors.initials: ME
authors.lastname: Bertrand
authors.forename: Antonio
authors.initials: A
authors.lastname: Colombo
authors.forename: Brent T
authors.initials: BT
authors.lastname: McLaurin
authors.forename: David A
authors.initials: DA
authors.lastname: Cox
authors.forename: Stuart J
authors.initials: SJ
authors.lastname: Pocock
authors.forename: James A
authors.initials: JA
authors.lastname: Ware
authors.forename: Steven V
authors.initials: SV
authors.lastname: Manoukian
authors.forename: Alexandra J
authors.initials: AJ
authors.lastname: Lansky
authors.forename: Roxana
authors.initials: R
authors.lastname: Mehran
authors.forename: Jeffrey W
authors.initials: JW
authors.lastname: Moses
authors.forename: Gregg W
authors.initials: GW
authors.lastname: Stone