Kenneth W. Mahaffey, md


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Kenneth W. Mahaffey, MD

  • Kenneth W. Mahaffey, MD

    • Research Grants: AstraZeneca, Bayer, BI, BMS, Eli Lilly, J&J, Merck, Novartis, Portola, Regado, Sanofi-Aventis, The Medicines Company
    • Consulting Fees: AstraZeneca, Bayer, BI, BMS, Eli Lilly, J&J, Merck, Novartis, Sanofi-Aventis
    • No stock ownership
    • http://www.dcri.duke.edu/research/coi.jsp
  • Keith AA Fox, MB ChB

    • Research Grants: Bayer, Eli Lilly, J&J, Sanofi-Aventis
    • Consulting Fees: Bayer, Eli Lilly, J&J, Sanofi-Aventis
    • No stock ownership


Direct, specific, competitive factor Xa inhibitor

  • Direct, specific, competitive factor Xa inhibitor

  • Half-life 5-13 hours

  • Clearance :

    • 1/3 direct renal excretion
    • 2/3 metabolism via CYP 450 enzymes
  • Oral, once daily dosing without need for coagulation monitoring

  • Studied in >25,000 patients in post-op, DVT, PE and ACS patients





Sample Size

  • Sample Size

    • Warfarin event rate ~2.3
    • Type 1 error 0.05 (2-sided)
    • 405 events; >95% power
    • ~14,000 patients
    • Primary Efficacy Evaluation: Stroke or non-CNS Embolism
      • Non-Inferiority: Protocol Compliant on treatment
      • Superiority: On Treatment and then by Intention-to-Treat
  • Primary Safety Evaluation: Major or non-Major Clinically Relevant Bleeding































Efficacy:

  • Efficacy:

    • Rivaroxaban was non-inferior to warfarin for prevention of stroke and non-CNS embolism.
    • Rivaroxaban was superior to warfarin while patients were taking study drug.
    • By intention-to-treat, rivaroxaban was non-inferior to warfarin but did not achieve superiority.
  • Safety:

    • Similar rates of bleeding and adverse events.
    • Less ICH and fatal bleeding with rivaroxaban.
  • Conclusion:

    • Rivaroxaban is a proven alternative to warfarin for moderate or high risk patients with AF.





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