Skip to main content
construction release_alert
Scholars@Duke will be undergoing maintenance April 11-15. Some features may be unavailable during this time.
cancel
Journal cover image

Rivaroxaban compared with warfarin in patients with atrial fibrillation and previous stroke or transient ischaemic attack: a subgroup analysis of ROCKET AF.

Publication ,  Journal Article
Hankey, GJ; Patel, MR; Stevens, SR; Becker, RC; Breithardt, G; Carolei, A; Diener, H-C; Donnan, GA; Halperin, JL; Mahaffey, KW; Mas, J-L ...
Published in: Lancet Neurol
April 2012

BACKGROUND: In ROCKET AF, rivaroxaban was non-inferior to adjusted-dose warfarin in preventing stroke or systemic embolism among patients with atrial fibrillation (AF). We aimed to investigate whether the efficacy and safety of rivaroxaban compared with warfarin is consistent among the subgroups of patients with and without previous stroke or transient ischaemic attack (TIA). METHODS: In ROCKET AF, patients with AF who were at increased risk of stroke were randomly assigned (1:1) in a double-blind manner to rivaroxaban 20 mg daily or adjusted dose warfarin (international normalised ratio 2·0-3·0). Patients and investigators were masked to treatment allocation. Between Dec 18, 2006, and June 17, 2009, 14 264 patients from 1178 centres in 45 countries were randomly assigned. The primary endpoint was the composite of stroke or non-CNS systemic embolism. In this substudy we assessed the interaction of the treatment effects of rivaroxaban and warfarin among patients with and without previous stroke or TIA. Efficacy analyses were by intention to treat and safety analyses were done in the on-treatment population. ROCKET AF is registered with ClinicalTrials.gov, number NCT00403767. FINDINGS: 7468 (52%) patients had a previous stroke (n=4907) or TIA (n=2561) and 6796 (48%) had no previous stroke or TIA. The number of events per 100 person-years for the primary endpoint in patients treated with rivaroxaban compared with warfarin was consistent among patients with previous stroke or TIA (2·79% rivaroxaban vs 2·96% warfarin; hazard ratio [HR] 0·94, 95% CI 0·77-1·16) and those without (1·44%vs 1·88%; 0·77, 0·58-1·01; interaction p=0·23). The number of major and non-major clinically relevant bleeding events per 100 person-years in patients treated with rivaroxaban compared with warfarin was consistent among patients with previous stroke or TIA (13·31% rivaroxaban vs 13·87% warfarin; HR 0·96, 95% CI 0·87-1·07) and those without (16·69%vs 15·19%; 1·10, 0·99-1·21; interaction p=0·08). INTERPRETATION: There was no evidence that the relative efficacy and safety of rivaroxaban compared with warfarin was different between patients who had a previous stroke or TIA and those who had no previous stroke or TIA. These results support the use of rivaroxaban as an alternative to warfarin for prevention of recurrent as well as initial stroke in patients with AF. FUNDING: Johnson and Johnson Pharmaceutical Research and Development and Bayer HealthCare.

Duke Scholars

Altmetric Attention Stats
Dimensions Citation Stats

Published In

Lancet Neurol

DOI

EISSN

1474-4465

Publication Date

April 2012

Volume

11

Issue

4

Start / End Page

315 / 322

Location

England

Related Subject Headings

  • Warfarin
  • Treatment Outcome
  • Thiophenes
  • Stroke
  • Secondary Prevention
  • Rivaroxaban
  • Neurology & Neurosurgery
  • Multicenter Studies as Topic
  • Morpholines
  • Ischemic Attack, Transient
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Hankey, G. J., Patel, M. R., Stevens, S. R., Becker, R. C., Breithardt, G., Carolei, A., … ROCKET AF Steering Committee Investigators, . (2012). Rivaroxaban compared with warfarin in patients with atrial fibrillation and previous stroke or transient ischaemic attack: a subgroup analysis of ROCKET AF. Lancet Neurol, 11(4), 315–322. https://doi.org/10.1016/S1474-4422(12)70042-X
Hankey, Graeme J., Manesh R. Patel, Susanna R. Stevens, Richard C. Becker, Günter Breithardt, Antonio Carolei, Hans-Christoph Diener, et al. “Rivaroxaban compared with warfarin in patients with atrial fibrillation and previous stroke or transient ischaemic attack: a subgroup analysis of ROCKET AF.Lancet Neurol 11, no. 4 (April 2012): 315–22. https://doi.org/10.1016/S1474-4422(12)70042-X.
Hankey GJ, Patel MR, Stevens SR, Becker RC, Breithardt G, Carolei A, et al. Rivaroxaban compared with warfarin in patients with atrial fibrillation and previous stroke or transient ischaemic attack: a subgroup analysis of ROCKET AF. Lancet Neurol. 2012 Apr;11(4):315–22.
Hankey, Graeme J., et al. “Rivaroxaban compared with warfarin in patients with atrial fibrillation and previous stroke or transient ischaemic attack: a subgroup analysis of ROCKET AF.Lancet Neurol, vol. 11, no. 4, Apr. 2012, pp. 315–22. Pubmed, doi:10.1016/S1474-4422(12)70042-X.
Hankey GJ, Patel MR, Stevens SR, Becker RC, Breithardt G, Carolei A, Diener H-C, Donnan GA, Halperin JL, Mahaffey KW, Mas J-L, Massaro A, Norrving B, Nessel CC, Paolini JF, Roine RO, Singer DE, Wong L, Califf RM, Fox KAA, Hacke W, ROCKET AF Steering Committee Investigators. Rivaroxaban compared with warfarin in patients with atrial fibrillation and previous stroke or transient ischaemic attack: a subgroup analysis of ROCKET AF. Lancet Neurol. 2012 Apr;11(4):315–322.
Journal cover image

Published In

Lancet Neurol

DOI

EISSN

1474-4465

Publication Date

April 2012

Volume

11

Issue

4

Start / End Page

315 / 322

Location

England

Related Subject Headings

  • Warfarin
  • Treatment Outcome
  • Thiophenes
  • Stroke
  • Secondary Prevention
  • Rivaroxaban
  • Neurology & Neurosurgery
  • Multicenter Studies as Topic
  • Morpholines
  • Ischemic Attack, Transient