title: Efficacy and safety of rivaroxaban in patients with heart failure and nonvalvular atrial fibrillation: insights from ROCKET AF.
abstract: BACKGROUND
  In Rivaroxaban Once daily, oral, direct factor Xa inhibition Compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF), rivaroxaban was noninferior to warfarin for the prevention of stroke and systemic embolic events and significantly reduced intracranial bleeding in patients with nonvalvular atrial fibrillation. We explore the safety and efficacy of rivaroxaban in patients with heart failure (HF).
  
  
  RESULTS
  A total of 9033 (63.7%) patients had HF. The primary efficacy analysis was rates of stroke or systemic embolism (per 100 patient-years) by intention to treat. The safety outcomes were major or nonmajor clinically relevant bleeding and hemorrhagic stroke during treatment. Patients with HF were younger (72 versus 74 years), more likely to have persistent atrial fibrillation (83.0% versus 77.6%), and had higher mean CHADS2 scores (3.7 versus 3.1). The efficacy of rivaroxaban compared with warfarin was similar in patients with HF (1.90 versus 2.09) and without HF (2.10 versus 2.54; P-interaction=0.62). The risk of major or nonmajor clinically relevant bleeding with rivaroxaban was similar to warfarin in patients with HF (14.22 versus 14.02) and without HF (16.12 versus 15.35; P-interaction=0.99). A reduction in hemorrhagic stroke was observed with rivaroxaban in patients with HF as in the overall trial (adjusted hazard ratio, 0.38; 95% confidence interval, 0.19-0.76; P-interaction=0.067). Among patients with HF, the efficacy of rivaroxaban was similar, irrespective of ejection fraction <40 or ≥ 40% (P-interaction=0.38), New York Heart Association class I-II versus III-IV (P-interaction=0.68), HF preserved or reduced ejection fraction (P-interaction=0.35), or CHADS2 score 2 versus ≥ 3 (P-interaction=0.48).
  
  
  CONCLUSIONS
  Treatment-related outcomes were similar in patients with and without HF and across HF subgroups. These findings support the use of rivaroxaban as an alternative to warfarin in patients with atrial fibrillation and HF. Clinical Trial Registration- URL: http://www.clinicaltrials.gov. Unique identifier: NCT00403767.
authors.affiliation: Divisions of Critical Care and Cardiology, University of Alberta, Edmonton, Alberta, Canada. sv9@ualberta.ca
authors.forename: Sean
authors.initials: S
authors.lastname: van Diepen
authors.forename: Anne S
authors.initials: AS
authors.lastname: Hellkamp
authors.forename: Manesh R
authors.initials: MR
authors.lastname: Patel
authors.forename: Richard C
authors.initials: RC
authors.lastname: Becker
authors.forename: Günter
authors.initials: G
authors.lastname: Breithardt
authors.forename: Werner
authors.initials: W
authors.lastname: Hacke
authors.forename: Jonathan L
authors.initials: JL
authors.lastname: Halperin
authors.forename: Graeme J
authors.initials: GJ
authors.lastname: Hankey
authors.forename: Christopher C
authors.initials: CC
authors.lastname: Nessel
authors.forename: Daniel E
authors.initials: DE
authors.lastname: Singer
authors.forename: Scott D
authors.initials: SD
authors.lastname: Berkowitz
authors.forename: Robert M
authors.initials: RM
authors.lastname: Califf
authors.forename: Keith A A
authors.initials: KA
authors.lastname: Fox
authors.forename: Kenneth W
authors.initials: KW
authors.lastname: Mahaffey
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000627:therapeutic use; D001281:Atrial Fibrillation / Q000188:drug therapy* / Q000453:epidemiology; D065427:Factor Xa Inhibitors; D005260:Female; D006333:Heart Failure / Q000188:drug therapy* / Q000453:epidemiology; D006801:Humans; D057194:Intention to Treat Analysis; D008297:Male; D008875:Middle Aged; D009025:Morpholines / Q000627:therapeutic use*; D000069552:Rivaroxaban; D013876:Thiophenes / Q000627:therapeutic use*; D016896:Treatment Outcome; D014859:Warfarin / Q000627:therapeutic use
chemical_list: D000925:Anticoagulants; D065427:Factor Xa Inhibitors; D009025:Morpholines; D013876:Thiophenes; D014859:Warfarin; D000069552:Rivaroxaban
keywords: anticoagulants; arrhythmias, cardiac; heart failure