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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, Büller 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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