title: Bivalirudin for primary percutaneous coronary interventions: outcome assessment in the Ottawa STEMI registry.
abstract: BACKGROUND
  Data from randomized trials has demonstrated the superiority of bivalirudin to glycoprotein IIb/IIIa inhibitors plus heparin in patients undergoing primary percutaneous coronary intervention. Real-world performance of bivalirudin in primary percutaneous coronary intervention and the benefit of bivalirudin over heparin remain unknown in an era of routine dual antiplatelet therapy.
  
  
  RESULTS
  From July 2004 to December 2010, 2317 consecutive patients were indexed in the University of Ottawa Heart Institute ST-segment-elevation myocardial infarction registry. During this period 748 patients received bivalirudin, 699 patients received glycoprotein IIb/IIIa inhibitors, and 676 patients received unfractionated heparin alone. The primary outcome was the rate of noncoronary artery bypass graft related thrombolysis in myocardial infarction major bleeding. Bivalirudin significantly reduced the primary outcome compared with heparin plus glycoprotein IIb/IIIa inhibitors (2.7% versus 7.3%, adjusted OR 2.96, 95% CI: 1.61-5.45, P<0.001) and the composite end point of death, stroke, reinfarction and major bleed (OR 1.66, 95% CI: 1.12-2.45, P=0.01). Compared with heparin alone, a reduction in major bleeds (OR 1.21, 95% CI: 0.60-2.44, P=0.59) or the composite end point (1.05, 95% CI: 0.68-1.63, P=0.83) with bivalirudin could not be demonstrated. Notably, major bleeding was associated with a 5-fold increase in the risk of mortality both in-hospital (3.5% versus 20.6%) and out to 180 days (5.6% versus 25.8%).
  
  
  CONCLUSIONS
  Bivalirudin use compared with glycoprotein IIb/IIIa inhibitors plus heparin as an antithrombotic strategy in primary percutaneous coronary intervention results in less major bleeding in contemporary practice. A benefit of bivalirudin over heparin could not be established with this registry and requires additional investigations to either confirm or refute.
authors.affiliation: Division of Cardiology, University of Ottawa Heart Institute, ON, Canada.
authors.forename: Benjamin
authors.initials: B
authors.lastname: Hibbert
authors.forename: Andrea
authors.initials: A
authors.lastname: MacDougall
authors.forename: Marino
authors.initials: M
authors.lastname: Labinaz
authors.forename: Edward R
authors.initials: ER
authors.lastname: O'Brien
authors.forename: Derek Y F
authors.initials: DY
authors.lastname: So
authors.forename: Alexander
authors.initials: A
authors.lastname: Dick
authors.forename: Christopher
authors.initials: C
authors.lastname: Glover
authors.forename: Michael
authors.initials: M
authors.lastname: Froeschl
authors.forename: Jean-Francois
authors.initials: JF
authors.lastname: Marquis
authors.forename: George A
authors.initials: GA
authors.lastname: Wells
authors.forename: Melissa
authors.initials: M
authors.lastname: Blondeau
authors.forename: Michel R
authors.initials: MR
authors.lastname: Le May
mesh_terms: D000368:Aged; D000925:Anticoagulants / Q000627:therapeutic use; D000991:Antithrombins / Q000009:adverse effects / Q000627:therapeutic use*; D016009:Chi-Square Distribution; D004359:Drug Therapy, Combination; D005260:Female; D005343:Fibrinolytic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D006470:Hemorrhage / Q000139:chemically induced / Q000517:prevention & control; D006493:Heparin / Q000627:therapeutic use; D006629:Hirudins / Q000009:adverse effects; D017052:Hospital Mortality; D006785:Hospitals, University; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000401:mortality / Q000628:therapy*; D016017:Odds Ratio; D009864:Ontario; D010446:Peptide Fragments / Q000009:adverse effects / Q000627:therapeutic use*; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000401:mortality; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D019039:Platelet Glycoprotein GPIIb-IIIa Complex / Q000037:antagonists & inhibitors; D057216:Propensity Score; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D012008:Recurrence; D012042:Registries; D012307:Risk Factors; D020521:Stroke / Q000209:etiology / Q000517:prevention & control; D013927:Thrombosis / Q000209:etiology / Q000517:prevention & control; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000925:Anticoagulants; D000991:Antithrombins; D005343:Fibrinolytic Agents; D006629:Hirudins; D010446:Peptide Fragments; D010975:Platelet Aggregation Inhibitors; D019039:Platelet Glycoprotein GPIIb-IIIa Complex; D011994:Recombinant Proteins; D006493:Heparin; C074619:bivalirudin