title: Impact of diabetes mellitus on the safety and effectiveness of bivalirudin in patients with acute myocardial infarction undergoing primary angioplasty: analysis from the HORIZONS-AMI (Harmonizing Outcomes with RevasculariZatiON and Stents in Acute Myocardial Infarction) trial.
abstract: OBJECTIVE
  We sought to evaluate the safety and efficacy of bivalirudin compared with glycoprotein IIb/IIIa inhibitors (GPI) in diabetic patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI).
  
  
  BACKGROUND
  Prior studies have demonstrated that GPI are especially beneficial in patients with diabetes with acute coronary syndromes and/or those undergoing PCI.
  
  
  METHODS
  In the multicenter, prospective HORIZONS-AMI (Harmonizing Outcomes with RevasculariZatiON and Stents in Acute Myocardial Infarction) trial, 3,602 patients with STEMI were randomized to bivalirudin or unfractionated heparin plus a GPI. Clinical outcomes were analyzed at 30 days and 1 year in patients with diabetes.
  
  
  RESULTS
  Diabetes mellitus was present in 593 patients (16.5%). The rates of cardiac death were significantly lower in diabetic patients treated with bivalirudin compared with heparin plus GPI (30 days: 2.1% vs. 5.5%, p = 0.04; 1 year: 2.5% vs. 7.1%, p = 0.01), and bivalirudin resulted in lower 30-day rates of stroke (0% vs. 2%, p = 0.02). There were no significant differences among diabetic patients randomized to bivalirudin versus heparin plus GPI in the 1-year rates of major adverse cardiac events (14.2% vs. 16.2%, p = 0.44), major bleeding (8.7% vs. 10.7%, p = 0.42), or stent thrombosis (4.2% vs. 3.8%, p = 0.85). By interaction testing, the relative effects of bivalirudin compared with heparin plus GPI were not significantly different in patients with and without diabetes.
  
  
  CONCLUSIONS
  In patients with diabetes mellitus presenting with STEMI undergoing primary PCI, anticoagulant therapy with bivalirudin compared with heparin plus GPI is safe and effective and might reduce cardiac mortality at 30 days and 1 year. (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction; NCT00433966).
authors.affiliation: Department of Cardiology and Pneumology, Charité Campus Benjamin Franklin, Berlin, Germany.
authors.forename: Bernhard
authors.initials: B
authors.lastname: Witzenbichler
authors.forename: Roxana
authors.initials: R
authors.lastname: Mehran
authors.forename: Giulio
authors.initials: G
authors.lastname: Guagliumi
authors.forename: Dariusz
authors.initials: D
authors.lastname: Dudek
authors.forename: Kurt
authors.initials: K
authors.lastname: Huber
authors.forename: Ran
authors.initials: R
authors.lastname: Kornowski
authors.forename: Thomas D
authors.initials: TD
authors.lastname: Stuckey
authors.forename: Martin
authors.initials: M
authors.lastname: Fahy
authors.forename: Helen
authors.initials: H
authors.lastname: Parise
authors.forename: Gregg W
authors.initials: GW
authors.lastname: Stone
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000379:methods*; D000991:Antithrombins / Q000008:administration & dosage / Q000627:therapeutic use; D017023:Coronary Angiography; D003920:Diabetes Mellitus / Q000188:drug therapy* / Q000401:mortality; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004562:Electrocardiography; D005260:Female; D005500:Follow-Up Studies; D006629:Hirudins / Q000008:administration & dosage; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000150:complications / Q000175:diagnosis / Q000628:therapy*; D010446:Peptide Fragments / Q000008:administration & dosage / Q000627:therapeutic use*; D011446:Prospective Studies; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000627:therapeutic use; D015607:Stents; D015996:Survival Rate / Q000639:trends; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000991:Antithrombins; D006629:Hirudins; D007004:Hypoglycemic Agents; D010446:Peptide Fragments; D011994:Recombinant Proteins; C074619:bivalirudin