title: Heparin monotherapy or bivalirudin during percutaneous coronary intervention in patients with non-ST-segment-elevation acute coronary syndromes or stable ischemic heart disease: results from the Evaluation of Drug-Eluting Stents and Ischemic Events registry.
abstract: BACKGROUND
  The use of bivalirudin versus unfractionated heparin monotherapy in patients without ST-segment-elevation myocardial infarction is not well defined.
  
  
  RESULTS
  The study population consisted of patients enrolled in the Evaluation of Drug-Eluting Stents and Ischemic Events (EVENT) registry with either non-ST-segment-elevation acute coronary syndromes or stable ischemic heart disease, who underwent percutaneous coronary intervention with either unfractionated heparin or bivalirudin monotherapy. Propensity score matching was used to adjust for baseline characteristics. The primary bleeding (in-hospital composite bleeding-access site bleeding, thrombolysis in myocardial infarction major/minor bleeding, or transfusion) and primary (in-hospital death/myocardial infarction) and secondary ischemic outcomes (death/myocardial infarction/unplanned repeat revascularization at 12 months) were evaluated. Propensity score matching yielded 1036 patients with non-ST-segment-elevation acute coronary syndromes and 2062 patients with stable ischemic heart disease. For the non-ST-segment-elevation acute coronary syndrome cohort, bivalirudin use was associated with lower bleeding (difference, -3.3% [-0.8% to -5.8%]; P=0.01; number need to treat=30) without increase in either primary (difference, 1.2% [4.1% to -1.8%]; P=0.45) or secondary ischemic outcomes, including stent thrombosis (difference, 0.0% [1.3% to -1.3%]; P=1.00). Similarly, in the stable ischemic heart disease cohort, bivalirudin use was associated with lower bleeding (difference, -1.8% [-0.4% to -3.3%]; P=0.01; number need to treat=53) without increase in either primary (difference, 0.4% [2.3% to -1.5%]; P=0.70) or secondary ischemic outcomes, including stent thrombosis (difference, 0.0% [0.7% to -0.7%]; P=1.00) when compared with unfractionated heparin monotherapy.
  
  
  CONCLUSIONS
  Among patients with non-ST-segment-elevation acute coronary syndromes or stable ischemic heart disease undergoing percutaneous coronary intervention, bivalirudin use during percutaneous coronary intervention when compared with unfractionated heparin monotherapy was associated with lower bleeding without significant increase in ischemic outcomes or stent thrombosis.
authors.affiliation: From the Department of Medicine, Division of Cardiology, New York University School of Medicine (S.B.); Department of Biostatistics and Bioinformatics, Duke Clinical Research Institute, Durham, NC (M.J.P.); Department of Cardiology, The Methodist DeBakey Heart and Vascular Center, Houston, TX (N.S.K.); and Department of Cardiology, Saint-Luke's Mid America Heart Institute, University of Missouri-Kansas City School of Medicine (D.J.C.). sripalbangalore@gmail.com.
authors.forename: Sripal
authors.initials: S
authors.lastname: Bangalore
authors.affiliation: From the Department of Medicine, Division of Cardiology, New York University School of Medicine (S.B.); Department of Biostatistics and Bioinformatics, Duke Clinical Research Institute, Durham, NC (M.J.P.); Department of Cardiology, The Methodist DeBakey Heart and Vascular Center, Houston, TX (N.S.K.); and Department of Cardiology, Saint-Luke's Mid America Heart Institute, University of Missouri-Kansas City School of Medicine (D.J.C.).
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Pencina
authors.affiliation: From the Department of Medicine, Division of Cardiology, New York University School of Medicine (S.B.); Department of Biostatistics and Bioinformatics, Duke Clinical Research Institute, Durham, NC (M.J.P.); Department of Cardiology, The Methodist DeBakey Heart and Vascular Center, Houston, TX (N.S.K.); and Department of Cardiology, Saint-Luke's Mid America Heart Institute, University of Missouri-Kansas City School of Medicine (D.J.C.).
authors.forename: Neal S
authors.initials: NS
authors.lastname: Kleiman
authors.affiliation: From the Department of Medicine, Division of Cardiology, New York University School of Medicine (S.B.); Department of Biostatistics and Bioinformatics, Duke Clinical Research Institute, Durham, NC (M.J.P.); Department of Cardiology, The Methodist DeBakey Heart and Vascular Center, Houston, TX (N.S.K.); and Department of Cardiology, Saint-Luke's Mid America Heart Institute, University of Missouri-Kansas City School of Medicine (D.J.C.).
authors.forename: David J
authors.initials: DJ
authors.lastname: Cohen
mesh_terms: D054058:Acute Coronary Syndrome / Q000628:therapy*; D000368:Aged; D000925:Anticoagulants / Q000009:adverse effects / Q000627:therapeutic use; D015331:Cohort Studies; D004562:Electrocardiography; D005260:Female; D005500:Follow-Up Studies; D006470:Hemorrhage / Q000453:epidemiology; D006493:Heparin / Q000009:adverse effects / Q000627:therapeutic use*; D006629:Hirudins / Q000009:adverse effects; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D017202:Myocardial Ischemia / Q000628:therapy*; D010446:Peptide Fragments / Q000009:adverse effects / Q000627:therapeutic use*; D062645:Percutaneous Coronary Intervention / Q000379:methods*; D011446:Prospective Studies; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D012042:Registries; D012307:Risk Factors; D013927:Thrombosis / Q000453:epidemiology / Q000517:prevention & control*; D016896:Treatment Outcome
chemical_list: D000925:Anticoagulants; D006629:Hirudins; D010446:Peptide Fragments; D011994:Recombinant Proteins; D006493:Heparin; C074619:bivalirudin
keywords: bivalirudin; heparin; percutaneous coronary intervention