title: Safety and efficacy of bivalirudin monotherapy in patients with diabetes mellitus and acute coronary syndromes: a report from the ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) trial.
abstract: OBJECTIVE
  We sought to evaluate clinical outcomes of patients with diabetes mellitus in the ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) trial, overall and by treatment arm.
  
  
  BACKGROUND
  In the ACUITY trial, 13,819 patients with moderate- or high-risk acute coronary syndromes (ACS) were randomized to heparin (unfractionated or enoxaparin) plus glycoprotein IIb/IIIa inhibition (GPI), bivalirudin plus GPI, or bivalirudin monotherapy. Compared with heparin plus GPI, bivalirudin monotherapy resulted in similar protection from ischemic events with less major bleeding. Whether these results apply to patients with diabetes is unknown.
  
  
  METHODS
  We evaluated the impact of diabetes on 30-day net adverse clinical outcomes (composite ischemia [death, myocardial infarction, or unplanned ischemic revascularization] or major bleeding), overall and by antithrombotic strategy.
  
  
  RESULTS
  Diabetes was present in 3,852 randomized patients (27.9%). Compared with nondiabetic patients, diabetic patients had higher 30-day rates of net adverse clinical outcomes (12.9% vs. 10.6%; p < 0.001), composite ischemia (8.7% vs. 7.2%; p = 0.003), and major bleeding (5.7% vs. 4.2%; p < 0.001). Among diabetic patients, compared with heparin plus GPI, bivalirudin plus GPI resulted in similar rates of net adverse clinical outcomes (14.0% vs. 13.8%; p = 0.89), while bivalirudin monotherapy resulted in a similar rate of composite ischemia (7.9% vs. 8.9%; p = 0.39) and less major bleeding (3.7% vs. 7.1%; p < 0.001), yielding fewer net adverse clinical outcomes (10.9% vs. 13.8%; p = 0.02).
  
  
  CONCLUSIONS
  Diabetic patients with ACS managed invasively have higher rates of composite ischemia and major bleeding. Compared with treatment with heparin plus GPI, bivalirudin monotherapy provides similar protection from ischemic events with less major bleeding, resulting in a significant reduction in net adverse clinical outcomes.
authors.affiliation: Division of Cardiology, Department of Medicine, New York University School of Medicine, New York, New York, USA. frederick.feit@med.nyu.edu
authors.forename: Frederick
authors.initials: F
authors.lastname: Feit
authors.forename: Steven V
authors.initials: SV
authors.lastname: Manoukian
authors.forename: Ramin
authors.initials: R
authors.lastname: Ebrahimi
authors.forename: Charles V
authors.initials: CV
authors.lastname: Pollack
authors.forename: E Magnus
authors.initials: EM
authors.lastname: Ohman
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Attubato
authors.forename: Roxana
authors.initials: R
authors.lastname: Mehran
authors.forename: Gregg W
authors.initials: GW
authors.lastname: Stone
mesh_terms: D054058:Acute Coronary Syndrome / Q000150:complications* / Q000188:drug therapy* / Q000378:metabolism / Q000503:physiopathology; D000208:Acute Disease; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000009:adverse effects / Q000627:therapeutic use*; D006328:Cardiac Catheterization; D048909:Diabetes Complications / Q000378:metabolism* / Q000503:physiopathology; D017984:Enoxaparin / Q000627:therapeutic use; D006493:Heparin / Q000627:therapeutic use; D006629:Hirudins / Q000009:adverse effects; D006801:Humans; D008297:Male; D008875:Middle Aged; 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; D012307:Risk Factors; D016896:Treatment Outcome
chemical_list: D000925:Anticoagulants; D017984:Enoxaparin; D006629:Hirudins; D010446:Peptide Fragments; D019039:Platelet Glycoprotein GPIIb-IIIa Complex; D011994:Recombinant Proteins; D006493:Heparin; C074619:bivalirudin