title: Clinical outcomes with rivaroxaban in patients transitioned from vitamin K antagonist therapy: a subgroup analysis of a randomized trial.
abstract: BACKGROUND
  In ROCKET AF (Rivaroxaban Once-Daily, Oral, Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation), a large randomized, clinical trial, rivaroxaban was noninferior to warfarin in preventing stroke or systemic embolism in patients with atrial fibrillation.
  
  
  OBJECTIVE
  To determine the efficacy and safety of rivaroxaban compared with warfarin among vitamin K antagonist (VKA)-naive and VKA-experienced patients.
  
  
  METHODS
  Prespecified subgroup analysis. (ClinicalTrials.gov: NCT00403767).
  
  
  METHODS
  Global.
  
  
  METHODS
  14,264 persons with atrial fibrillation.
  
  
  METHODS
  Interaction of the relative treatment effect of rivaroxaban and warfarin on stroke or systemic embolism among VKA-naive and VKA-experienced patients.
  
  
  RESULTS
  Overall, 7897 (55.4%) patients were VKA-experienced and 6367 (44.6%) were VKA-naive. The effect of rivaroxaban versus warfarin on stroke or systemic embolism was consistent: Rates per 100 patient-years of follow-up were 2.32 versus 2.87 for VKA-naive patients (hazard ratio [HR], 0.81 [95% CI, 0.64 to 1.03]) and 1.98 versus 2.09 for VKA-experienced patients (HR, 0.94 [CI, 0.75 to 1.18]; interaction P = 0.36). During the first 7 days, rivaroxaban was associated with more bleeding than warfarin (HR in VKA-naive patients, 5.83 [CI, 3.25 to 10.44], and in VKA-experienced patients, 6.66 [CI, 3.83 to 11.58]; interaction P = 0.53). After 30 days, rivaroxaban was associated with less bleeding than warfarin in VKA-naive patients (HR, 0.84 [CI, 0.74 to 0.95]) and similar bleeding in VKA-experienced patients (HR, 1.06 [CI, 0.96 to 1.17]; interaction P = 0.003).
  
  
  CONCLUSIONS
  The trial was not designed to detect differences in these subgroups.
  
  
  CONCLUSIONS
  The efficacy of rivaroxaban in VKA-experienced and VKA-naive patients was similar to that of the overall trial. There were more bleeding events within 7 days of study drug initiation with rivaroxaban, but after 30 days, rivaroxaban was associated with less bleeding in VKA-naive patients and similar bleeding in VKA-experienced patients. This information may be useful to clinicians considering a transition to rivaroxaban for patients receiving VKA therapy.
  
  
  BACKGROUND
  Johnson & Johnson and Bayer HealthCare.
authors.affiliation: Duke Clinical Research Institute, Duke University Medical Center, Durham, NC 27705, USA. kenneth.mahaffey@dm.duke.edu
authors.forename: Kenneth W
authors.initials: KW
authors.lastname: Mahaffey
authors.forename: Daniel
authors.initials: D
authors.lastname: Wojdyla
authors.forename: Graeme J
authors.initials: GJ
authors.lastname: Hankey
authors.forename: Harvey D
authors.initials: HD
authors.lastname: White
authors.forename: Christopher C
authors.initials: CC
authors.lastname: Nessel
authors.forename: Jonathan P
authors.initials: JP
authors.lastname: Piccini
authors.forename: Manesh R
authors.initials: MR
authors.lastname: Patel
authors.forename: Scott D
authors.initials: SD
authors.lastname: Berkowitz
authors.forename: Richard C
authors.initials: RC
authors.lastname: Becker
authors.forename: Jonathan L
authors.initials: JL
authors.lastname: Halperin
authors.forename: Daniel E
authors.initials: DE
authors.lastname: Singer
authors.forename: Robert M
authors.initials: RM
authors.lastname: Califf
authors.forename: Keith A A
authors.initials: KA
authors.lastname: Fox
authors.forename: Günter
authors.initials: G
authors.lastname: Breithardt
authors.forename: Werner
authors.initials: W
authors.lastname: Hacke
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000009:adverse effects / Q000627:therapeutic use*; D001281:Atrial Fibrillation / Q000150:complications*; D057186:Comparative Effectiveness Research; D004617:Embolism / Q000517:prevention & control*; D065427:Factor Xa Inhibitors; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009025:Morpholines / Q000009:adverse effects / Q000627:therapeutic use*; D000069552:Rivaroxaban; D020521:Stroke / Q000517:prevention & control*; D013876:Thiophenes / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D014812:Vitamin K / Q000037:antagonists & inhibitors*; D014859:Warfarin / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D000925:Anticoagulants; D065427:Factor Xa Inhibitors; D009025:Morpholines; D013876:Thiophenes; D014812:Vitamin K; D014859:Warfarin; D000069552:Rivaroxaban