title: Net clinical benefit of rivaroxaban versus warfarin in Japanese patients with nonvalvular atrial fibrillation: a subgroup analysis of J-ROCKET AF.
abstract: BACKGROUND
  The risk factors that have been identified for bleeding events with rivaroxaban are predominantly the same as those predicting thromboembolic ones in patients with atrial fibrillation (AF). Our aim was to determine the net clinical benefit (NCB) from the results of the J-ROCKET AF trial, in which rivaroxaban was compared with warfarin in Japanese patients with AF.
  
  
  METHODS
  Two strategies were adopted to quantify the NCB. First, the NCB was calculated as the number of ischemic strokes avoided with anticoagulation minus the number of excess intracranial hemorrhage (ICH) with a weight of 1.5. Second, the composite end point of major bleeding events and secondary efficacy end points (stroke, noncentral nervous system systemic embolism, myocardial infarction and death) to ascertain the NCB were established. Subgroup analysis by CHADS2 score or creatinine clearance was also performed.
  
  
  RESULTS
  The adjusted NCB, which was given a weight of 1.5 for ICH, was nominally significant in favor of rivaroxaban therapy (difference in incidence rate -2.13; 95% confidence interval [CI]: -.26 to -3.99). Furthermore, the event rate of the composite end point tended to be lower in patients treated with rivaroxaban than in those treated with warfarin (rivaroxaban: 4.97% per year, warfarin: 6.11% per year; difference in incidence rate: -1.14; 95% CI: -3.40 to 1.12). The event rate of the composite end point tended to be consistently low in patients treated with rivaroxaban in the subanalysis by CHADS2 score and renal function.
  
  
  CONCLUSIONS
  Analysis of the NCB supports that rivaroxaban therapy provides clinical benefit for Japanese patients with AF.
authors.affiliation: Department of Neurology, Tokyo Women's Medical University, Tokyo, Japan. Electronic address: suchiyam@nij.twmu.ac.jp.
authors.forename: Shinichiro
authors.initials: S
authors.lastname: Uchiyama
authors.affiliation: Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan.
authors.forename: Masatsugu
authors.initials: M
authors.lastname: Hori
authors.affiliation: Department of Clinical Neuroscience and Therapeutics, Hiroshima University, Hiroshima, Japan.
authors.forename: Masayasu
authors.initials: M
authors.lastname: Matsumoto
authors.affiliation: Department of Neurology, Saitama Medical University International Medical Center, Saitama, Japan.
authors.forename: Norio
authors.initials: N
authors.lastname: Tanahashi
authors.affiliation: Division of Cardiovascular Medicine, Saitama Medical Center, Jichi Medical University, Saitama, Japan.
authors.forename: Shin-Ichi
authors.initials: S
authors.lastname: Momomura
authors.affiliation: Department of Medicine (Cardiology), Tokai University School of Medicine, Tokyo, Japan.
authors.forename: Shinya
authors.initials: S
authors.lastname: Goto
authors.affiliation: Department of Cardio-angiology, Kitasato University School of Medicine, Sagamihara City, Kanagawa, Japan.
authors.forename: Tohru
authors.initials: T
authors.lastname: Izumi
authors.affiliation: Institute for Clinical Research, Osaka National Hospital, Osaka, Japan.
authors.forename: Yukihiro
authors.initials: Y
authors.lastname: Koretsune
authors.affiliation: Bayer Yakuhin Ltd, Osaka, Japan.
authors.forename: Mariko
authors.initials: M
authors.lastname: Kajikawa
authors.affiliation: Bayer Yakuhin Ltd, Osaka, Japan.
authors.forename: Masaharu
authors.initials: M
authors.lastname: Kato
authors.affiliation: Bayer Yakuhin Ltd, Osaka, Japan.
authors.forename: Hitoshi
authors.initials: H
authors.lastname: Ueda
authors.affiliation: Bayer Yakuhin Ltd, Osaka, Japan.
authors.forename: Kazuma
authors.initials: K
authors.lastname: Iekushi
authors.affiliation: Bayer Yakuhin Ltd, Osaka, Japan.
authors.forename: Satoshi
authors.initials: S
authors.lastname: Yamanaka
authors.affiliation: Bayer Yakuhin Ltd, Osaka, Japan.
authors.forename: Masahiro
authors.initials: M
authors.lastname: Tajiri
mesh_terms: D000925:Anticoagulants / Q000009:adverse effects / Q000627:therapeutic use*; D044466:Asian People; D001281:Atrial Fibrillation / Q000175:diagnosis / Q000188:drug therapy* / Q000208:ethnology / Q000401:mortality; D002545:Brain Ischemia / Q000175:diagnosis / Q000208:ethnology / Q000401:mortality / Q000517:prevention & control*; D004311:Double-Blind Method; D065427:Factor Xa Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D020300:Intracranial Hemorrhages / Q000139:chemically induced / Q000208:ethnology; D007564:Japan; D009025:Morpholines / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D000069552:Rivaroxaban; D020521:Stroke / Q000175:diagnosis / Q000208:ethnology / Q000401:mortality / Q000517:prevention & control*; D013876:Thiophenes / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome; D014859:Warfarin / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D000925:Anticoagulants; D065427:Factor Xa Inhibitors; D009025:Morpholines; D013876:Thiophenes; D014859:Warfarin; D000069552:Rivaroxaban
keywords: Atrial fibrillation; net clinical benefit; oral anticoagulation; stroke prevention