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Systematic review and meta-analysis

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

atrial fibrillation - antithrombotics - primary prevention of thromboembolic events

atrial fibrillation - new oral anticoagulants - all type of patients


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See also:

  • All atrial fibrillation clinical trials
  • All clinical trials of new oral anticoagulants
  • All clinical trials of idraparinux
    		•  
     AMADEUS study, 2008 TRC7223 
    [NCT00070655] download pdf: idraparinux | antithrombotics for atrial fibrillation

    Treatments

    Studied treatment subcutaneous idraparinux 2�5 mg weekly
    Control treatment adjusted-dose vitamin K antagonists (target of an international normalised ratio of 2�3)

    Patients

    Patients patients with atrial fi brillation at risk for thromboembolism
    Inclusion criteria ECG-documented non-valvular atrial fi brillation and an indication for long-term anticoagulation based on the presence of at least one of the following risk factors: previous ischaemic stroke, transient ischaemic attack or systemic embolism, hypertension requiring drug treatment, left ventricular dysfunction, age over 75 years, or age 65�75 years with either diabetes mellitus or symptomatic coronary artery disease
    Baseline characteristics
    subgroup test a 

    Method and design

    Randomized effectives 2283 / 2293 (studied vs. control)
    Design Parallel groups
    Blinding open
    Follow-up duration 10.7 months
    Premature discontinuation Premature discontinuation for safety reason
    Hypothesis Non inferiority
    Primary endpoint all stroke and systemic embolism

    Remarks / Comments

    The trial was prematurely stopped because of excess clinically relevant bleeding with idraparinux



    Results

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

    thrombo-embolic event (cerebral or systemic)

    18 / 1922
         27 / 2107
         0,73 [0,40;1,32]

    systemic thrombo-embolic complication

    0 / 1922
         2 / 2107
         classic 0,12 [0,00;7,59]

    ischemic stroke

    13 / 1922
         20 / 2107
         0,71 [0,36;1,43]

    All cause death

    62 / 1941
         61 / 2131
         1,12 [0,79;1,58]

    Bleeding

    346 / 1756
         226 / 1994
         classic 1,74 [1,49;2,03]

    Major bleeding

    74 / 1908
         29 / 1994
         classic 2,67 [1,74;4,08]

    Fatal bleeding

    13 / 1941
         2 / 2131
         classic 7,14 [1,61;31,58]

    Fatal stroke

    0 / 1941
         1 / 2131
         classic 0,22 [0,00;16,08]

    TE event or ischemic stroke or systemic embolism

    18 / 1922
         27 / 2107
         0,73 [0,40;1,32]

    intracranial hemorrhage

    4 / 1922
         5 / 2107
         classic 0,88 [0,24;3,26]     0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial    		 Ref
    Studied treat. Control treat.
    thrombo-embolic event (cerebral or systemic) 18 / 1922 (0,9%) 27 / 2107 (1,3%) 0,73 [0,40;1,32]  
    systemic thrombo-embolic complication 0 / 1922 (0,0%) 2 / 2107 (0,1%) 0,27 [0,01;6,07]  
    ischemic stroke 13 / 1922 (0,7%) 20 / 2107 (0,9%) 0,71 [0,36;1,43]  
    All cause death 62 / 1941 (3,2%) 61 / 2131 (2,9%) 1,12 [0,79;1,58]  
    Bleeding 346 / 1756 (19,7%) 226 / 1994 (11,3%) 1,74 [1,49;2,03]  
    Major bleeding 74 / 1908 (3,9%) 29 / 1994 (1,5%) 2,67 [1,74;4,08]  
    Fatal bleeding 13 / 1941 (0,7%) 2 / 2131 (0,1%) 7,14 [1,61;31,58]  
    Fatal stroke 0 / 1941 (0,0%) 1 / 2131 (0,0%) 0,55 [0,02;16,35]  
    TE event or ischemic stroke or systemic embolism 18 / 1922 (0,9%) 27 / 2107 (1,3%) 0,73 [0,40;1,32]  
    intracranial hemorrhage 4 / 1922 (0,2%) 5 / 2107 (0,2%) 0,88 [0,24;3,26]  
    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 (for a follow-up of 10.7 months)
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    thrombo-embolic event (cerebral or systemic) 9,37‰ 1,28% -0,34%
    ischemic stroke 6,76‰ 9,49‰ -0,27%
    All cause death 3,19% 2,86% 0,33%
    Bleeding 19,70% 11,33% 8,4%
    Major bleeding 3,88% 1,45% 2,4%
    Fatal bleeding 6,70‰ 0,94‰ 0,58%
    TE event or ischemic stroke or systemic embolism 9,37‰ 1,28% -0,34%
    intracranial hemorrhage 2,08‰ 2,37‰ -0,03%

    Meta-analysis of all similar trials:

    antithrombotics in atrial fibrillation for primary prevention of thromboembolic events

    new oral anticoagulants in atrial fibrillation for all type of patients



    Reference(s)

    TrialResults-center ID TRC7223
    Trials register # NCT00070655
    Study web site link ,
    • Bousser MG, Bouthier J, B�ller HR, Cohen AT, Crijns H, Davidson BL, Halperin J, Hankey G, Levy S, Pengo V, Prandoni P, Prins MH, Tomkowski W, Thorp-Pedersen C, Wyse DG. Comparison of idraparinux with vitamin K antagonists for prevention of thromboembolism in patients with atrial fibrillation: a randomised, open-label, non-inferiority trial.. Lancet 2008;371:315-21
      Pubmed | Hubmed | Fulltext

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