Advertisement

Rivaroxaban versus Warfarin in Japanese Patients with Nonvalvular Atrial Fibrillation in Relation to the CHADS2 Score: A Subgroup Analysis of the J-ROCKET AF Trial

      Background

      Results from a trial of rivaroxaban versus warfarin in 1280 Japanese patients with atrial fibrillation (J-ROCKET AF) revealed that rivaroxaban was noninferior to warfarin with respect to the principal safety outcome. In this subanalysis, we investigated the safety and efficacy of rivaroxaban and warfarin in relation to patients' CHADS2 scores.

      Results

      The mean CHADS2 score was 3.25, and the most frequent scores were 3 and 4. No statistically significant interactions were observed between principal safety outcome event rates and CHADS2 scores with respect to treatment groups (P value for interaction = .700). Irrespective of stratification into moderate- and high-risk groups based on CHADS2 scores of 2 and 3 or more, respectively, no differences in principal safety outcome event rates were observed between rivaroxaban- and warfarin-treated patients (moderate-risk group: hazard ratio [HR], 1.06; 95% confidence interval [CI], .58-1.95; high-risk group: HR, 1.11; 95% CI, .86-1.45; P value for interaction = .488). The primary efficacy end point rate in the rivaroxaban-treated group was numerically lower than in the warfarin-treated group, regardless of risk group stratification (moderate-risk group: HR, .46; 95% CI, .09-2.37; high-risk group: HR, .49; 95% CI, .22-1.11; P value for interaction = .935).

      Conclusion

      This subanalysis indicated that the safety and efficacy of rivaroxaban compared with warfarin were similar, regardless of CHADS2 score.

      Key Words

      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      Subscribe:

      Subscribe to Journal of Stroke and Cerebrovascular Diseases
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

        • Wolf P.A.
        • Abbott R.D.
        • Kannel W.B.
        Atrial fibrillation as an independent risk factor for stroke: the Framingham Study.
        Stroke. 1991; 22: 983-988
        • Stroke Risk in Atrial Fibrillation Working Group
        Comparison of 12 risk stratification schemes to predict stroke in patients with nonvalvular atrial fibrillation.
        Stroke. 2008; 39: 1901-1910
        • Inoue H.
        • Nozawa T.
        • Hirai T.
        • et al.
        Accumulation of risk factors increases risk of thromboembolic events in patients with nonvalvular atrial fibrillation.
        Circ J. 2006; 70: 651-656
        • Gage B.F.
        • Waterman A.D.
        • Shannon W.
        • et al.
        Validation of clinical classification schemes for predicting stroke: results from the National Registry of Atrial Fibrillation.
        JAMA. 2001; 285: 2864-2870
        • Hori M.
        • Matsumoto M.
        • Tanahashi N.
        • et al.
        Rivaroxaban vs. warfarin in Japanese patients with atrial fibrillation—the J-ROCKET AF study.
        Circ J. 2012; 76: 2104-2111
        • Patel M.R.
        • Mahaffey K.W.
        • Garg J.
        • et al.
        Rivaroxaban versus warfarin in nonvalvular atrial fibrillation.
        N Engl J Med. 2011; 365: 883-891
        • Tanahashi N.
        • Hori M.
        • Matsumoto M.
        • et al.
        Rivaroxaban versus warfarin in Japanese patients with nonvalvular atrial fibrillation for the secondary prevention of stroke: a subgroup analysis of J-ROCKET AF.
        J Stroke Cerebrovasc Dis. 2013; (in press)
        • Singer D.E.
        • Chang Y.
        • Fang M.C.
        • et al.
        The net clinical benefit of warfarin anticoagulation in atrial fibrillation.
        Ann Int Med. 2009; 151: 297-305
        • Banerjee A.
        • Lane D.A.
        • Torp-Pedersen C.
        • et al.
        Net clinical benefit of new oral anticoagulants (dabigatran, rivaroxaban, apixaban) versus no treatment in a 'real world' atrial fibrillation population: a modelling analysis based on a nationwide cohort study.
        Thromb Haemost. 2012; 107: 584-589
        • Shen A.Y.
        • Yao J.F.
        • Brar S.S.
        • et al.
        Racial/ethnic differences in the risk of intracranial hemorrhage among patients with atrial fibrillation.
        J Am Coll Cardiol. 2007; 50: 309-315
        • Dentali F.
        • Riva N.
        • Crowther M.
        • et al.
        Efficacy and safety of the novel oral anticoagulants in atrial fibrillation: a systematic review and meta-analysis of the literature.
        Circulation. 2012; 126: 2381-2391
        • Camm A.J.
        • Lip G.Y.
        • De Caterina R.
        • et al.
        2012 focused update of the ESC Guidelines for the management of atrial fibrillation: an update of the 2010 ESC Guidelines for the management of atrial fibrillation. Developed with the special contribution of the European Heart Rhythm Association.
        Eur Heart J. 2012; 33: 2719-2747
        • Fuster V.
        • Ryden L.E.
        • Cannom D.S.
        • et al.
        2011 ACCF/AHA/HRS focused updates incorporated into the ACC/AHA/ESC 2006 guidelines for the management of patients with atrial fibrillation: a report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines.
        Circulation. 2011; 123: e269-e367
        • Skanes A.C.
        • Healey J.S.
        • Cairns J.A.
        • et al.
        Focused 2012 update of the Canadian Cardiovascular Society atrial fibrillation guidelines: recommendations for stroke prevention and rate/rhythm control.
        Can J Cardiol. 2012; 28: 125-136
        • European Heart Rhythm Association
        • European Association for Cardio-Thoracic Surgery
        • Camm A.J.
        • et al.
        Guidelines for the management of atrial fibrillation: the Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC).
        Eur Heart J. 2010; 31: 2369-2429
        • Pisters R.
        • Lane D.A.
        • Nieuwlaat R.
        • et al.
        A novel user-friendly score (HAS-BLED) to assess 1-year risk of major bleeding in patients with atrial fibrillation: the Euro Heart Survey.
        Chest. 2010; 138: 1093-1100