title: Bivalirudin for patients with acute coronary syndromes.
abstract: BACKGROUND
  Current guidelines for patients with moderate- or high-risk acute coronary syndromes recommend an early invasive approach with concomitant antithrombotic therapy, including aspirin, clopidogrel, unfractionated or low-molecular-weight heparin, and glycoprotein IIb/IIIa inhibitors. We evaluated the role of thrombin-specific anticoagulation with bivalirudin in such patients.
  
  
  METHODS
  We assigned 13,819 patients with acute coronary syndromes to one of three antithrombotic regimens: unfractionated heparin or enoxaparin plus a glycoprotein IIb/IIIa inhibitor, bivalirudin plus a glycoprotein IIb/IIIa inhibitor, or bivalirudin alone. The primary end points were a composite ischemia end point (death, myocardial infarction, or unplanned revascularization for ischemia), major bleeding, and the net clinical outcome, defined as the combination of composite ischemia or major bleeding.
  
  
  RESULTS
  Bivalirudin plus a glycoprotein IIb/IIIa inhibitor, as compared with heparin plus a glycoprotein IIb/IIIa inhibitor, was associated with noninferior 30-day rates of the composite ischemia end point (7.7% and 7.3%, respectively), major bleeding (5.3% and 5.7%), and the net clinical outcome end point (11.8% and 11.7%). Bivalirudin alone, as compared with heparin plus a glycoprotein IIb/IIIa inhibitor, was associated with a noninferior rate of the composite ischemia end point (7.8% and 7.3%, respectively; P=0.32; relative risk, 1.08; 95% confidence interval [CI], 0.93 to 1.24) and significantly reduced rates of major bleeding (3.0% vs. 5.7%; P<0.001; relative risk, 0.53; 95% CI, 0.43 to 0.65) and the net clinical outcome end point (10.1% vs. 11.7%; P=0.02; relative risk, 0.86; 95% CI, 0.77 to 0.97).
  
  
  CONCLUSIONS
  In patients with moderate- or high-risk acute coronary syndromes who were undergoing invasive treatment with glycoprotein IIb/IIIa inhibitors, bivalirudin was associated with rates of ischemia and bleeding that were similar to those with heparin. Bivalirudin alone was associated with similar rates of ischemia and significantly lower rates of bleeding. (ClinicalTrials.gov number, NCT00093158 [ClinicalTrials.gov].).
authors.affiliation: Columbia University Medical Center and the Cardiovascular Research Foundation, New York, NY 10022, USA. gs2184@columbia.edu
authors.forename: Gregg W
authors.initials: GW
authors.lastname: Stone
authors.forename: Brent T
authors.initials: BT
authors.lastname: McLaurin
authors.forename: David A
authors.initials: DA
authors.lastname: Cox
authors.forename: Michel E
authors.initials: ME
authors.lastname: Bertrand
authors.forename: A Michael
authors.initials: AM
authors.lastname: Lincoff
authors.forename: Jeffrey W
authors.initials: JW
authors.lastname: Moses
authors.forename: Harvey D
authors.initials: HD
authors.lastname: White
authors.forename: Stuart J
authors.initials: SJ
authors.lastname: Pocock
authors.forename: James H
authors.initials: JH
authors.lastname: Ware
authors.forename: Frederick
authors.initials: F
authors.lastname: Feit
authors.forename: Antonio
authors.initials: A
authors.lastname: Colombo
authors.forename: Philip E
authors.initials: PE
authors.lastname: Aylward
authors.forename: Angel R
authors.initials: AR
authors.lastname: Cequier
authors.forename: Harald
authors.initials: H
authors.lastname: Darius
authors.forename: Walter
authors.initials: W
authors.lastname: Desmet
authors.forename: Ramin
authors.initials: R
authors.lastname: Ebrahimi
authors.forename: Martial
authors.initials: M
authors.lastname: Hamon
authors.forename: Lars H
authors.initials: LH
authors.lastname: Rasmussen
authors.forename: Hans-Jürgen
authors.initials: HJ
authors.lastname: Rupprecht
authors.forename: James
authors.initials: J
authors.lastname: Hoekstra
authors.forename: Roxana
authors.initials: R
authors.lastname: Mehran
authors.forename: E Magnus
authors.initials: EM
authors.lastname: Ohman
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000789:Angina, Unstable / Q000188:drug therapy* / Q000628:therapy; D015906:Angioplasty, Balloon, Coronary; D000925:Anticoagulants / Q000009:adverse effects / Q000627:therapeutic use*; D001026:Coronary Artery Bypass; D004359:Drug Therapy, Combination; D017984:Enoxaparin / Q000627:therapeutic use; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced; D006493:Heparin / Q000627:therapeutic use; D006629:Hirudins / Q000009:adverse effects; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D017202:Myocardial Ischemia / Q000453:epidemiology; D010446:Peptide Fragments / Q000009:adverse effects / Q000627:therapeutic use*; D019039:Platelet Glycoprotein GPIIb-IIIa Complex / Q000037:antagonists & inhibitors; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use
chemical_list: D000925:Anticoagulants; D017984:Enoxaparin; D006629:Hirudins; D010446:Peptide Fragments; D019039:Platelet Glycoprotein GPIIb-IIIa Complex; D011994:Recombinant Proteins; D006493:Heparin; C074619:bivalirudin