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Systematic review and meta-analysis

This trial is included in the following systematic reviews and meta-analyses:

venous thrombosis - new oral anticoagulants - all types of patients


Related trials

AMPLIFY, 2013 - apixaban (without LMWH) vs LMWH/VKA

Edoxaban Hokusai VTE, 2013 - heparin/edoxaban vs heparin/VKA

AMPLIFY-EXT 5mg, 2012 - apixaban 5mg vs discontinuation

AMPLIFY-EXT 2.5mg, 2012 - apixaban 2.5mg vs discontinuation

Einstein-PE Evaluation, 2012 - rivaroxaban (without LMWH) vs LMWH/VKA

RE-MEDY, 2011 - dabigatran vs warfarin

RE-COVER II, 2011 - heparin/dabigatran vs heparin/VKA

RE-SONATE, 2011 - dabigatran vs discontinuation

Einstein-DVT Evaluation, 2010 - rivaroxaban (without LMWH) vs LMWH/VKA

EINSTEIN-extension, 2009 - rivaroxaban vs discontinuation

RE-COVER, 2009 - heparin/dabigatran vs heparin/VKA

Einstein-DVT Dose-Ranging Study, 2008 - rivaroxaban (without LMWH) vs LMWH/VKA

Botticelli DVT, 2008 - apixaban (without LMWH) vs LMWH/VKA

VanGogh extension, 2007 - idraparinux vs discontinuation

THRIVE I, 2003 - ximelagatran (without LMWH) vs LMWH/VKA

THRIVE III, 2003 - ximelagatran vs discontinuation



See also:

  • All venous thrombosis clinical trials
  • All clinical trials of new oral anticoagulants
  • All clinical trials of heparin/edoxaban
    		•  

    Edoxaban Hokusai VTE study, 2013

    [NCT00986154] download pdf: heparin/edoxaban | new oral anticoagulants for venous thrombosis

    Treatments

    Studied treatment heparin then edoxaban 60mg daily (30mg if creatine clearnce of 30 to 50 ml/min or <60kg) for 3 to 12 months
    edoxaban at a dose of 60 mg once daily, or 30 mg once daily (e.g., in the case of patients with creatinine clearance of 30 to 50 ml per minute or a body weight below 60 kg) after initial treatment with heparin of at least 5 days
    Control treatment heparin then warfarin
    Concomittant treatment initial treatment with heparin of at least 5 days

    Patients

    Patients patients with acute venous thromboembolism, who had initially received heparin,

    Method and design

    Randomized effectives 4143 / 4149 (studied vs. control)
    Design Parallel groups
    Blinding double-blind
    Hypothesis Non inferiority
    Primary endpoint recurrent symptomatic venous thromboembolism


    Results



    Endpoints and data reported in the trial's publication(s)

    Endpoint Events (%) Relative Risk 95% CI
    Studied treat. Control treat.
    Event during overall study period 130 / 4143 (3,1%) 146 / 4149 (3,5%) 0,89 [0,71;1,12]
    Fatal PE during study period 4 / 4143 (0,1%) 3 / 4149 (0,1%) 1,34 [0,30;5,96]
    Death, with PE not ruled out during study period 20 / 4143 (0,5%) 21 / 4149 (0,5%) 0,95 [0,52;1,76]
    Nonfatal PE with or without DVT during study period 49 / 4143 (1,2%) 59 / 4149 (1,4%) 0,83 [0,57;1,21]
    DVT alone during study period 57 / 4143 (1,4%) 63 / 4149 (1,5%) 0,91 [0,63;1,29]
    Event during on-treatment period 66 / 4143 (1,6%) 80 / 4149 (1,9%) 0,83 [0,60;1,14]
    major or clinically relevant nonmajor bleeding 349 / 4143 (8,4%) 423 / 4149 (10,2%) 0,83 [0,72;0,95]
    Major bleeding 56 / 4143 (1,4%) 66 / 4149 (1,6%) 0,85 [0,60;1,21]
    Fatal bleeding 2 / 4143 (0,0%) 10 / 4149 (0,2%) 0,20 [0,04;0,91]
    Intracranial Fatal bleeding 0 / 4143 (0,0%) 6 / 4149 (0,1%) 0,08 [0,00;1,49]
    Gastrointestinal Fatal bleeding 1 / 4143 (0,0%) 2 / 4149 (0,0%) 0,50 [0,05;5,52]
    Retroperitoneal Fatal bleeding 0 / 4143 (0,0%) 1 / 4149 (0,0%) 0,50 [0,02;14,92]
    Other Fatal bleeding 1 / 4143 (0,0%) 1 / 4149 (0,0%) 1,00 [0,06;16,01]
    Nonfatal major bleeding 13 / 4143 (0,3%) 25 / 4149 (0,6%) 0,52 [0,27;1,02]
    Intracranial Nonfatal major bleeding 5 / 4143 (0,1%) 12 / 4149 (0,3%) 0,42 [0,15;1,18]
    Retroperitoneal Nonfatal major bleeding 0 / 4143 (0,0%) 3 / 4149 (0,1%) 0,17 [0,01;3,33]
    Other Nonfatal major bleeding 8 / 4143 (0,2%) 10 / 4149 (0,2%) 0,80 [0,32;2,03]
    Nonfatal in noncritical site major bleeding 41 / 4143 (1,0%) 33 / 4149 (0,8%) 1,24 [0,79;1,96]
    Clinically relevant nonmajor bleeding 298 / 4143 (7,2%) 368 / 4149 (8,9%) 0,81 [0,70;0,94]
    Any bleeding 895 / 4143 (21,6%) 1056 / 4149 (25,5%) 0,85 [0,79;0,92]

    Endpoints used by the meta-analysis and data retained for this trial

    Endpoint Studied treat.
    n/N     Control treat.
    n/N     Graph RR [95% CI]

    Bleeding

    895 / 4143
         1056 / 4149
         0,85 [0,79;0,92]

    fatal pulmonary embolism

    4 / 4143
         3 / 4149
         classic 1,34 [0,30;5,96]

    major or clinically relevant non-major bleeding

    349 / 4143
         423 / 4149
         0,83 [0,72;0,95]

    Major bleeding

    56 / 4143
         66 / 4149
         0,85 [0,60;1,21]

    recurrent VTE during treatment

    66 / 4143
         80 / 4149
         0,83 [0,60;1,14]

    non-fatal pulmonary embolism

    49 / 4143
         59 / 4149
         0,83 [0,57;1,21]     0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial    		 Ref
    Studied treat. Control treat.
    Major bleeding 56 / 4143 (1,4%) 66 / 4149 (1,6%) 0,85 [0,60;1,21] Major bleeding 
    recurrent VTE during treatment 66 / 4143 (1,6%) 80 / 4149 (1,9%) 0,83 [0,60;1,14] Event during on-treatment period 
    non-fatal pulmonary embolism 49 / 4143 (1,2%) 59 / 4149 (1,4%) 0,83 [0,57;1,21] Nonfatal PE with or without DVT during study period  
    major or clinically relevant non-major bleeding 349 / 4143 (8,4%) 423 / 4149 (10,2%) 0,83 [0,72;0,95] major or clinically relevant nonmajor bleeding  
    Bleeding 895 / 4143 (21,6%) 1056 / 4149 (25,5%) 0,85 [0,79;0,92] Any bleeding 
    fatal pulmonary embolism 4 / 4143 (0,1%) 3 / 4149 (0,1%) 1,34 [0,30;5,96] Fatal PE during study period  
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:
  • 0:

    • Endpoint studied treat. control treat. mean diff

    Absolute risk reduction
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    Major bleeding 1,35% 1,59% -2,4‰
    recurrent VTE during treatment 1,59% 1,93% -3,4‰
    non-fatal pulmonary embolism 1,18% 1,42% -2,4‰
    major or clinically relevant non-major bleeding 8,42% 10,20% -17,7‰
    Bleeding 21,60% 25,45% -38,5‰
    fatal pulmonary embolism 0,97‰ 0,72‰ 0,2‰

    Meta-analysis of all similar trials:

    new oral anticoagulants in venous thrombosis for all types of patients



    Reference(s)

    Trials register # NCT00986154

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