title: Safety and efficacy of bivalirudin in high-risk patients admitted through the emergency department.
abstract: OBJECTIVE
  The objective was to assess the safety and efficacy of bivalirudin monotherapy in patients with high-risk acute coronary syndrome (ACS) presenting to the emergency department (ED).
  
  
  METHODS
  Data from the Acute Catheterization and Urgent Intervention Triage StrategY (ACUITY) trial were used to conduct a post hoc subgroup analysis of high-risk ACS patients (cardiac biomarker elevation or ST-segment deviation) who initially presented to the ED. The ACUITY trial randomized patients to receive heparin (unfractionated [UFH] or enoxaparin) plus glycoprotein IIb/IIIa inhibition (GPI), bivalirudin plus GPI, or bivalirudin monotherapy. Endpoints included composite ischemia, major bleeding (not coronary artery bypass graft (CABG) related), and net clinical outcome (major bleeding plus composite ischemia).
  
  
  RESULTS
  Of 13,819 participants in the ACUITY trial, 6,441 presented initially to the ED, met high-risk criteria, and were included in the primary analysis. Bivalirudin alone when compared to heparin plus GPI, after adjusting for covariates, was associated with an improvement in net clinical outcome (12.3% vs. 14.3%, adjusted odds ratio [OR] = 0.81, 95% confidence interval [CI] = 0.66 to 0.99), similar composite ischemia (9.3% vs. 9.1%, adjusted OR = 0.98, 95% CI = 0.77 to 1.24), and less major bleeding (4.0% vs. 6.8%, adjusted OR = 0.57, 95% CI = 0.42 to 0.75). Bivalirudin plus GPI when compared to heparin plus GPI had similar net clinical outcome (13.8% vs. 14.3%, adjusted OR = 0.91, 95% CI = 0.75 to 1.11), composite ischemia (8.8% vs. 9.1%, adjusted OR = 0.87, 95% CI = 0.69 to 1.11), and major bleeding (6.8% vs. 6.8%, adjusted OR = 1.01, 95% CI = 0.79 to 1.30).
  
  
  CONCLUSIONS
  Bivalirudin monotherapy decreases major bleeding while providing similar protection from ischemic events compared to heparin plus GPI in patients with high-risk ACS admitted through the ED.
authors: Department of Emergency Medicine, Wake Forest University School of Medicine, Winston-Salem, NC. cmiller@wfubmc.edu
authors: Chadwick D
authors: CD
authors: Miller
authors: Andra L
authors: AL
authors: Blomkalns
authors: Bernard J
authors: BJ
authors: Gersh
authors: Charles V
authors: CV
authors: Pollack
authors: Gerard X
authors: GX
authors: Brogan
authors: Deborah B
authors: DB
authors: Diercks
authors: W Frank
authors: WF
authors: Peacock
authors: Gregg W
authors: GW
authors: Stone
authors: Judd E
authors: JE
authors: Hollander
authors: Steven V
authors: SV
authors: Manoukian
authors: James W
authors: JW
authors: Hoekstra
mesh_terms: D054058:Acute Coronary Syndrome / Q000188:drug therapy*; D000368:Aged; D000925:Anticoagulants / Q000627:therapeutic use*; D016009:Chi-Square Distribution; D015897:Comorbidity; D004636:Emergency Service, Hospital; D017984:Enoxaparin / Q000627:therapeutic use; D005260:Female; D006493:Heparin / Q000627:therapeutic use; D006629:Hirudins; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D010446:Peptide Fragments / Q000627:therapeutic use*; D011994:Recombinant Proteins / Q000627:therapeutic use; D016896:Treatment Outcome; D014218:Triage
chemical_list: D000925:Anticoagulants; D017984:Enoxaparin; D006629:Hirudins; D010446:Peptide Fragments; D011994:Recombinant Proteins; D006493:Heparin; C074619:bivalirudin