Also in a real-world setting, novel oral anticoagulants were associated with better outcomes

Real-World Evidence of Stroke Prevention in Patients with Nonvalvular Atrial Fibrillation in the United States: the REVISIT-US Study

Literature - Coleman C, et al, Curr Med Res Opin, 2016

Coleman C, Antz M, Bowrin K, et al.
Curr Med Res Opin. 2016 Sep 20:1-7. [Epub ahead of print]


Randomised clinical trials have demonstrated favourable efficacy and safety profiles for the oral factor Xa inhibitors rivaroxaban, apixaban, edoxaban, compared to warfarin [1-3]. However, in clinical practice oral anticoagulants (OACs) may be used differently.

In the ‘Real-world evidence on stroke prevention in patients with atrial fibrillation in the United States’ (REVISIT-US) study, the efficacy and safety of rivaroxaban or apixaban was compared to warfarin in NVAF patients in a real-life setting using data from a large, US administrative claims database. Patients were OAC treatment naïve in the 180-days prior to the treatment and had never been treated to rivaroxaban or apixaban. Each eligible rivaroxaban user or apixaban user was 1:1 propensity-score matched to a warfarin user. Primary endpoints were ischemic stroke and intracranial hemorrhage (ICH).

Main results

  • 11.411 rivaroxaban users were matched to 11.411 warfarin users.
  • A lower hazard of ischemic stroke or ICH was noticed for rivaroxaban users compared to warfarin users (HR: 0.61, 95% CI: 0.45-0.82).
  • Separately, both HRs for stroke and ICH were lower for rivaroxaban compared to warfarin (HR: 0.71, 95% CI: 0.47-1.07 and HR:0.53, 95% CI: 0.35-0.79 respectively).
  • 4.083 apixaban users were matched to 4.083 warfarin users.
  • A lower hazard of ischemic stroke or ICH was noticed for apixaban users compared to warfarin users (HR: 0.63, 95% CI: 0.35-1.12), although non-significant.
  • Separately, the HR for ICH was 0.38 (95% CI: 0.17-0.88), whereas this increased for ischemic stroke (HR: 1.13, 95% CI: 0.49-2.63, non-statistically).


The real-world REVISIT-US study of NVAF patients within the United States confirmed results of the corresponding phase III trials (ROCKET-AF, ARISTOTLE); both rivaroxaban and apixaban were associated with less intracranial haemorrhage versus warfarin. Further investigations need to be done regarding the non-statistically significant higher rate of ischemic stroke with apixaban compared to warfarin, as this was observed in a relatively small number of patients. One explanation might be the more frequently use of the reduced apixaban dose (2.5mg twice daily) or poor adherence.

Find this article online at Curr Med Res Opin


1. Patel MR, Mahaffey KW, Garg J, et al.; ROCKET AF Investigators. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med. 2011;365:883-891.
2. Granger CB, Alexander JH, McMurray JJ, et al., ARISTOTLE Committees and Investigators. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2011;365:981-92.
3. Giugliano RP, Ruff CT, Braunwald E, Murphy SA et al., ENGAGE AF-TIMI 48 Investigators. Edoxaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2013;369:2093-104.

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