Efficacy and safety of rivaroxaban versus warfarin in patients from mainland China with nonvalvular atrial fibrillation: A subgroup analysis from the ROCKET AF trial

Yihong Sun, Dayi Hu, Susanna Stevens, Yuliya Lokhnygina, Richard C. Becker, Scott D. Berkowitz, Günter Breithardt, Werner Hacke, Jonathan L. Halperin, Graeme J. Hankey, Kenneth W. Mahaffey, Christopher C. Nessel, Jonathan P. Piccini, Daniel E. Singer, Keith A. A. Fox, Manesh R. Patel

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    Abstract

    Background: The ROCKET AF study evaluated once-daily rivaroxaban versus dose-adjusted warfarin for the prevention of stroke and systemic embolism in patients with atrial fibrillation (AF). In this analysis, we compared rivaroxaban with warfarin in patients with AF from China, East Asia, and the rest of the world (ROW). Methods and results: We assessed baseline demographics and interaction of treatment effects of rivaroxaban versus warfarin among patients from mainland China, other East Asian countries, and ROW. Of the 14,236 patients enrolled in the per-protocol population, 495 were from mainland China, 433 from other East-Asian regions, and 13,308 from the rest of the world (ROW). At baseline, patients from China had significantly higher rates of previous stroke/transient ischemic attack (TIA) compared with patients from other East Asian regions and ROW (79.6%, 44.6%, 51.6% respectively; p. <. 0.0001) and lower rates of VKA use (33.7%, 66.7%, 63.4%, respectively; p. <. 0.0001). The rates of stroke or systemic embolism among those on warfarin while on treatment was 5.23% in patients from China, 1.82% in those from other East Asian regions, and 2.07% from ROW; on rivaroxaban, the rates were 2.29% in patients from China, 1.86% in those from other east Asian regions, and 1.67% from ROW. There were no significant treatment-by-region interactions for any efficacy or safety outcome (all p. >. 0.12). Numerically higher rates of intracranial bleeding were seen in patients from China receiving warfarin versus rivaroxaban. Conclusions: In patients from China, rates of intracranial hemorrhage were numerically lower among those receiving rivaroxaban and consistent with the overall trial. Clinical trial registration: URL: https://www.clinicaltrials.gov/. Unique identifier: NCT00403767.

    Original languageEnglish
    Pages (from-to)184–190
    JournalThrombosis Research
    Volume156
    DOIs
    Publication statusPublished - Aug 2017

    Fingerprint

    Warfarin
    Atrial Fibrillation
    China
    Safety
    Stroke
    Far East
    Rivaroxaban
    Intracranial Hemorrhages
    Transient Ischemic Attack
    Embolism
    Demography
    Clinical Trials
    Hemorrhage
    Population

    Cite this

    Sun, Yihong ; Hu, Dayi ; Stevens, Susanna ; Lokhnygina, Yuliya ; Becker, Richard C. ; Berkowitz, Scott D. ; Breithardt, Günter ; Hacke, Werner ; Halperin, Jonathan L. ; Hankey, Graeme J. ; Mahaffey, Kenneth W. ; Nessel, Christopher C. ; Piccini, Jonathan P. ; Singer, Daniel E. ; Fox, Keith A. A. ; Patel, Manesh R. / Efficacy and safety of rivaroxaban versus warfarin in patients from mainland China with nonvalvular atrial fibrillation : A subgroup analysis from the ROCKET AF trial. In: Thrombosis Research. 2017 ; Vol. 156. pp. 184–190.
    @article{0a37c5d84b67490a8f2c5f061962e53d,
    title = "Efficacy and safety of rivaroxaban versus warfarin in patients from mainland China with nonvalvular atrial fibrillation: A subgroup analysis from the ROCKET AF trial",
    abstract = "Background: The ROCKET AF study evaluated once-daily rivaroxaban versus dose-adjusted warfarin for the prevention of stroke and systemic embolism in patients with atrial fibrillation (AF). In this analysis, we compared rivaroxaban with warfarin in patients with AF from China, East Asia, and the rest of the world (ROW). Methods and results: We assessed baseline demographics and interaction of treatment effects of rivaroxaban versus warfarin among patients from mainland China, other East Asian countries, and ROW. Of the 14,236 patients enrolled in the per-protocol population, 495 were from mainland China, 433 from other East-Asian regions, and 13,308 from the rest of the world (ROW). At baseline, patients from China had significantly higher rates of previous stroke/transient ischemic attack (TIA) compared with patients from other East Asian regions and ROW (79.6{\%}, 44.6{\%}, 51.6{\%} respectively; p. <. 0.0001) and lower rates of VKA use (33.7{\%}, 66.7{\%}, 63.4{\%}, respectively; p. <. 0.0001). The rates of stroke or systemic embolism among those on warfarin while on treatment was 5.23{\%} in patients from China, 1.82{\%} in those from other East Asian regions, and 2.07{\%} from ROW; on rivaroxaban, the rates were 2.29{\%} in patients from China, 1.86{\%} in those from other east Asian regions, and 1.67{\%} from ROW. There were no significant treatment-by-region interactions for any efficacy or safety outcome (all p. >. 0.12). Numerically higher rates of intracranial bleeding were seen in patients from China receiving warfarin versus rivaroxaban. Conclusions: In patients from China, rates of intracranial hemorrhage were numerically lower among those receiving rivaroxaban and consistent with the overall trial. Clinical trial registration: URL: https://www.clinicaltrials.gov/. Unique identifier: NCT00403767.",
    keywords = "China, Hemorrhage, Nonvalvular atrial fibrillation, Rivaroxaban, Stroke",
    author = "Yihong Sun and Dayi Hu and Susanna Stevens and Yuliya Lokhnygina and Becker, {Richard C.} and Berkowitz, {Scott D.} and G{\"u}nter Breithardt and Werner Hacke and Halperin, {Jonathan L.} and Hankey, {Graeme J.} and Mahaffey, {Kenneth W.} and Nessel, {Christopher C.} and Piccini, {Jonathan P.} and Singer, {Daniel E.} and Fox, {Keith A. A.} and Patel, {Manesh R.}",
    year = "2017",
    month = "8",
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    pages = "184–190",
    journal = "Thrombosis Research",
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    Sun, Y, Hu, D, Stevens, S, Lokhnygina, Y, Becker, RC, Berkowitz, SD, Breithardt, G, Hacke, W, Halperin, JL, Hankey, GJ, Mahaffey, KW, Nessel, CC, Piccini, JP, Singer, DE, Fox, KAA & Patel, MR 2017, 'Efficacy and safety of rivaroxaban versus warfarin in patients from mainland China with nonvalvular atrial fibrillation: A subgroup analysis from the ROCKET AF trial' Thrombosis Research, vol. 156, pp. 184–190. https://doi.org/10.1016/j.thromres.2017.04.010

    Efficacy and safety of rivaroxaban versus warfarin in patients from mainland China with nonvalvular atrial fibrillation : A subgroup analysis from the ROCKET AF trial. / Sun, Yihong; Hu, Dayi; Stevens, Susanna; Lokhnygina, Yuliya; Becker, Richard C.; Berkowitz, Scott D.; Breithardt, Günter; Hacke, Werner; Halperin, Jonathan L.; Hankey, Graeme J.; Mahaffey, Kenneth W.; Nessel, Christopher C.; Piccini, Jonathan P.; Singer, Daniel E.; Fox, Keith A. A.; Patel, Manesh R.

    In: Thrombosis Research, Vol. 156, 08.2017, p. 184–190.

    Research output: Contribution to journalArticle

    TY - JOUR

    T1 - Efficacy and safety of rivaroxaban versus warfarin in patients from mainland China with nonvalvular atrial fibrillation

    T2 - A subgroup analysis from the ROCKET AF trial

    AU - Sun, Yihong

    AU - Hu, Dayi

    AU - Stevens, Susanna

    AU - Lokhnygina, Yuliya

    AU - Becker, Richard C.

    AU - Berkowitz, Scott D.

    AU - Breithardt, Günter

    AU - Hacke, Werner

    AU - Halperin, Jonathan L.

    AU - Hankey, Graeme J.

    AU - Mahaffey, Kenneth W.

    AU - Nessel, Christopher C.

    AU - Piccini, Jonathan P.

    AU - Singer, Daniel E.

    AU - Fox, Keith A. A.

    AU - Patel, Manesh R.

    PY - 2017/8

    Y1 - 2017/8

    N2 - Background: The ROCKET AF study evaluated once-daily rivaroxaban versus dose-adjusted warfarin for the prevention of stroke and systemic embolism in patients with atrial fibrillation (AF). In this analysis, we compared rivaroxaban with warfarin in patients with AF from China, East Asia, and the rest of the world (ROW). Methods and results: We assessed baseline demographics and interaction of treatment effects of rivaroxaban versus warfarin among patients from mainland China, other East Asian countries, and ROW. Of the 14,236 patients enrolled in the per-protocol population, 495 were from mainland China, 433 from other East-Asian regions, and 13,308 from the rest of the world (ROW). At baseline, patients from China had significantly higher rates of previous stroke/transient ischemic attack (TIA) compared with patients from other East Asian regions and ROW (79.6%, 44.6%, 51.6% respectively; p. <. 0.0001) and lower rates of VKA use (33.7%, 66.7%, 63.4%, respectively; p. <. 0.0001). The rates of stroke or systemic embolism among those on warfarin while on treatment was 5.23% in patients from China, 1.82% in those from other East Asian regions, and 2.07% from ROW; on rivaroxaban, the rates were 2.29% in patients from China, 1.86% in those from other east Asian regions, and 1.67% from ROW. There were no significant treatment-by-region interactions for any efficacy or safety outcome (all p. >. 0.12). Numerically higher rates of intracranial bleeding were seen in patients from China receiving warfarin versus rivaroxaban. Conclusions: In patients from China, rates of intracranial hemorrhage were numerically lower among those receiving rivaroxaban and consistent with the overall trial. Clinical trial registration: URL: https://www.clinicaltrials.gov/. Unique identifier: NCT00403767.

    AB - Background: The ROCKET AF study evaluated once-daily rivaroxaban versus dose-adjusted warfarin for the prevention of stroke and systemic embolism in patients with atrial fibrillation (AF). In this analysis, we compared rivaroxaban with warfarin in patients with AF from China, East Asia, and the rest of the world (ROW). Methods and results: We assessed baseline demographics and interaction of treatment effects of rivaroxaban versus warfarin among patients from mainland China, other East Asian countries, and ROW. Of the 14,236 patients enrolled in the per-protocol population, 495 were from mainland China, 433 from other East-Asian regions, and 13,308 from the rest of the world (ROW). At baseline, patients from China had significantly higher rates of previous stroke/transient ischemic attack (TIA) compared with patients from other East Asian regions and ROW (79.6%, 44.6%, 51.6% respectively; p. <. 0.0001) and lower rates of VKA use (33.7%, 66.7%, 63.4%, respectively; p. <. 0.0001). The rates of stroke or systemic embolism among those on warfarin while on treatment was 5.23% in patients from China, 1.82% in those from other East Asian regions, and 2.07% from ROW; on rivaroxaban, the rates were 2.29% in patients from China, 1.86% in those from other east Asian regions, and 1.67% from ROW. There were no significant treatment-by-region interactions for any efficacy or safety outcome (all p. >. 0.12). Numerically higher rates of intracranial bleeding were seen in patients from China receiving warfarin versus rivaroxaban. Conclusions: In patients from China, rates of intracranial hemorrhage were numerically lower among those receiving rivaroxaban and consistent with the overall trial. Clinical trial registration: URL: https://www.clinicaltrials.gov/. Unique identifier: NCT00403767.

    KW - China

    KW - Hemorrhage

    KW - Nonvalvular atrial fibrillation

    KW - Rivaroxaban

    KW - Stroke

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    U2 - 10.1016/j.thromres.2017.04.010

    DO - 10.1016/j.thromres.2017.04.010

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    EP - 190

    JO - Thrombosis Research

    JF - Thrombosis Research

    SN - 0049-3848

    ER -