title: CHA2DS2-VASc Scores and Major Bleeding in Patients With Nonvalvular Atrial Fibrillation Who Are Receiving Rivaroxaban.
abstract: OBJECTIVE
  Assessing stroke risk associated with nonvalvular atrial fibrillation depends on the evaluation of patient characteristics and clinical features. Clinicians must determine that the net clinical benefit from anticoagulation therapy outweighs its risk, namely, bleeding. Risk assessment for stroke is commonly performed by calculating a CHA2DS2-VASc (congestive heart failure/left ventricular dysfunction, hypertension, ≥75 years, diabetes mellitus, previous stroke or transient ischemic attack or thromboembolism, vascular disease, aged 65 to 74 years, sex female) score. It is possible that CHA2DS2-VASc scores also have a relationship with the incidence of major bleeding. We examined the relationship between CHA2DS2-VASc scores and major bleeding in rivaroxaban users with nonvalvular atrial fibrillation.
  
  
  METHODS
  Electronic medical records of more than 10 million patients from the Department of Defense Military Health System were queried to identify patients with nonvalvular atrial fibrillation who received rivaroxaban from January 1, 2013, to June 30, 2015. Baseline characteristics of the study population were described by CHA2DS2-VASc scores and major bleeding status; major bleeding incidence was evaluated by CHA2DS2-VASc score category and for each CHA2DS2-VASc component.
  
  
  RESULTS
  Overall, 44,793 patients met the inclusion criteria for this analysis. The major bleeding incidence rate was 2.84 (95% confidence interval 2.69 to 3.00) per 100 person-years. The incidence of major bleeding increased from 0.30 to 5.40 per 100 person-years among patients with a CHA2DS2-VASc score of 0 to 5 or higher, respectively. Fatal outcomes among patients with major bleeding were positively correlated with CHA2DS2-VASc scores; patients with higher scores had higher mortality rates. The CHA2DS2-VASc component with the highest major bleeding incidence was for vascular disease, 5.69 (95% confidence interval 5.18 to 6.24) per 100 person-years.
  
  
  CONCLUSIONS
  Higher CHA2DS2-VASc scores are associated with increased incidence of major bleeding in nonvalvular atrial fibrillation patients receiving rivaroxaban.
authors.affiliation: Department of Emergency Medicine, Baylor College of Medicine, Houston, TX. Electronic address: frankpeacock@gmail.com.
authors.forename: W Frank
authors.initials: WF
authors.lastname: Peacock
authors.affiliation: Department of Cardiology, Marine Corps, United States Navy, Naval Medical Center, Portsmouth, VA.
authors.forename: Sally
authors.initials: S
authors.lastname: Tamayo
authors.affiliation: Duke University Health System and Duke Clinical Research Institute, Durham, NC.
authors.forename: Manesh
authors.initials: M
authors.lastname: Patel
authors.affiliation: Clinical Epidemiology, Health ResearchTx, LLC, Trevose, PA.
authors.forename: Nicholas
authors.initials: N
authors.lastname: Sicignano
authors.affiliation: Clinical Epidemiology, Health ResearchTx, LLC, Trevose, PA.
authors.forename: Kathleen P
authors.initials: KP
authors.lastname: Hopf
authors.affiliation: Janssen Research and Development, LLC, Titusville, NJ.
authors.forename: Zhong
authors.initials: Z
authors.lastname: Yuan
mesh_terms: D000368:Aged; D001281:Atrial Fibrillation / Q000188:drug therapy*; D065427:Factor Xa Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced*; D006801:Humans; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D000069552:Rivaroxaban / Q000009:adverse effects / Q000627:therapeutic use*; D020521:Stroke / Q000517:prevention & control*
chemical_list: D065427:Factor Xa Inhibitors; D000069552:Rivaroxaban