title: Comparison of Four Bleeding Risk Scores to Identify Rivaroxaban-treated Patients With Venous Thromboembolism at Low Risk for Major Bleeding.
abstract: OBJECTIVE
  Outpatient treatment of acute venous thromboembolism (VTE) requires the selection of patients with a low risk of bleeding during the first few weeks of anticoagulation. The accuracy of four systems, originally derived for predicting bleeding in VTE treated with vitamin K antagonists (VKAs), was assessed in VTE patients treated with rivaroxaban.
  
  
  METHODS
  All patients treated with rivaroxaban in the multinational EINSTEIN deep vein thrombosis (DVT) and pulmonary embolism (PE) trials were included. Major bleeding was defined as ≥2 g/dL drop in hemoglobin or ≥2-unit blood transfusion, bleeding in critical area, or bleeding contributing to death. The authors examined the incidence of major bleeding in patients with low-risk assignment by the systems of Ruiz-Gimenez et al. (score = 0 to 1), Beyth et al. (score = 0), Kuijer et al. (score = 0), and Landefeld and Goldman. (score = 0). For clinical relevance, the definition of low risk for all scores except Kuijer includes all patients < 65 years with no prior bleeding history and no comorbid conditions (current cancer, renal insufficiency, diabetes mellitus, anemia, prior stroke, or myocardial infarction).
  
  
  RESULTS
  A total of 4,130 patients (1,731 with DVT only, 2,399 with PE with or without DVT) were treated with rivaroxaban for a mean (±SD) duration of 207.6 (±95.9) days. Major bleeding occurred in 1.0% (40 of 4,130; 95% confidence interval [CI] = 0.7% to 1.3%) overall. Rates of major bleeding for low-risk patients during the entire treatment period were similar: Ruiz-Gimenez et al., 12 of 2,622 (0.5%; 95% CI = 0.2% to 0.8%); Beyth et al., nine of 2,249 (0.4%; 95% CI = 0.2% to 0.8%); Kuijer et al., four of 1,186 (0.3%; 95% CI = 0.1% to 0.9%); and Landefeld and Goldman, 11 of 2,407 (0.5%; 95% CI = 0.2% to 0.8%). At 30 days, major bleed rates for low-risk patients were as follows: Ruiz-Gimenez et al., five of 2,622 (0.2%; 95% CI = 0.1% to 0.4%); Beyth et al., five of 2,249 (0.2%; 95% CI = 0.1% to 0.5%); Kuijer et al., three of 1,186 (0.3%; 95% CI = 0.1% to 0.7%); and Landefeld and Goldman, seven of 2,407 (0.3%; 95% CI = 0.1% to 0.6%). No low-risk patient had a fatal bleed.
  
  
  CONCLUSIONS
  Four scoring systems that use criteria obtained in routine clinical practice, derived to predict low bleeding risk with VKA treatment for VTE, identified patients with less than a 1% risk of major bleeding during full-course treatment with rivaroxaban.
authors.affiliation: Department of Emergency Medicine and Department of Cellular and Integrative Physiology, Indiana University School of Medicine, Indianapolis, IN.
authors.forename: Jeffrey A
authors.initials: JA
authors.lastname: Kline
authors.affiliation: Respiratory Department and Medicine Department, Ramon y Cajal Hospital IRYCIS, Madrid, Spain.|Alcala de Henares University, Madrid, Spain.
authors.forename: David
authors.initials: D
authors.lastname: Jimenez
authors.affiliation: Department of Emergency Medicine, Northwestern University School of Medicine, Chicago, IL.
authors.forename: D Mark
authors.initials: DM
authors.lastname: Courtney
authors.affiliation: Division of Biostatistics, Medical Affairs (Cardiovascular and Metabolism), Raritan, NJ.|Janssen Research and Development, LLC, Raritan, NJ.
authors.forename: Juliana
authors.initials: J
authors.lastname: Ianus
authors.affiliation: Janssen Research and Development, LLC, Raritan, NJ.
authors.forename: Lynn
authors.initials: L
authors.lastname: Cao
authors.affiliation: Bayer HealthCare AG, Leverkusen, Germany.
authors.forename: Anthonie W A
authors.initials: AW
authors.lastname: Lensing
authors.affiliation: Maastricht University Medical Center, Maastricht, the Netherlands.
authors.forename: Martin H
authors.initials: MH
authors.lastname: Prins
authors.affiliation: Department of Medicine, University of Ottawa and the Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
authors.forename: Philip S
authors.initials: PS
authors.lastname: Wells
mesh_terms: D000368:Aged; D000925:Anticoagulants / Q000009:adverse effects* / Q000627:therapeutic use; D000066491:Clinical Decision-Making; D004636:Emergency Service, Hospital / Q000458:organization & administration*; D065427:Factor Xa Inhibitors; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011237:Predictive Value of Tests; D011655:Pulmonary Embolism / Q000188:drug therapy; D018570:Risk Assessment; D000069552:Rivaroxaban / Q000009:adverse effects* / Q000627:therapeutic use; D054556:Venous Thromboembolism / Q000188:drug therapy*; D020246:Venous Thrombosis / Q000188:drug therapy; D014812:Vitamin K / Q000037:antagonists & inhibitors
chemical_list: D000925:Anticoagulants; D065427:Factor Xa Inhibitors; D014812:Vitamin K; D000069552:Rivaroxaban