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See also:

  • All atrial fibrillation clinical trials
  • All clinical trials of new oral anticoagulants
  • All clinical trials of dabigatran 150mg
  •  
     RE-LY (150mg) study, 2009 TRC7218 
    [NCT00262600] download pdf: dabigatran 150mg | antithrombotics for atrial fibrillation

    Treatments

    Studied treatment dabigatran 150 mg twice a day
    Control treatment warfarin adjusted-dose to a 2.0 to 3.0 INR
    Remarks 3 arms: dabigatran 110 mg, 150mg and warfarin
    Treatments description
    time within the therapeutic range (%) 64% mean 

    Patients

    Patients Patients With Non-Valvular Atrial Fibrillation
    Inclusion criteria Patients with non-valvular atrial fibrillation (AF), at moderate to high risk of stroke, or systemic embolism with at least one additional risk factor (i.e. pre vious ischemic stroke, TIA, or systemic embolism, left ventricular dysfunction, age >=75 years, age >=65 with either diabetes mellitus, history of coronary artery disease or hy pertension)
    Baseline characteristics
    age(mean) 71.5y 
    male(%) 63.3% 
    weight(mean) 82.6 kg 
    systolic blood pressure(mean) 131.1 mm Hg 
    diastolic blood pressure(mean) 77 mmHg 
    hypertension(%) 78.9% 
    diabete mellitus(%) 23.2% 
    prior TIA or stroke(%) 20% 
    prior myocardial infarction(%) 16.5% 
    paroxysmal AF(%) 33.2% 
    subgroup test
    CHADS2 Score (mean) 2.1 
    CHADS2 Score = 2 (%) 36% 
    CHADS2 Score = 3 (%) 32% (CHADS2>=3) 

    Method and design

    Randomized effectives 6076 / 6022 (studied vs. control)
    Design Parallel groups
    Blinding open (blind assessment)
    Follow-up duration 2 y (median)
    Lost to follow-up 0.1% (20/18113)
    Number of centre 951
    Geographic area 44 countries
    Hypothesis Non inferiority
    Primary endpoint stroke or systemic embolism
    Withdrawals (T1/T0) 21.2% / 16.6%


    Results



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

    Endpoint Events (%) Relative Risk 95% CI
    Studied treat. Control treat.
    Stroke or systemic embolism 134 / 6076 (2,2%) 199 / 6022 (3,3%) 0,67 [0,54;0,83]
    Stroke 122 / 6076 (2,0%) 185 / 6022 (3,1%) 0,65 [0,52;0,82]
    Hemorrhagic 12 / 6076 (0,2%) 45 / 6022 (0,7%) 0,26 [0,14;0,50]
    Ischemic or unspecified 111 / 6076 (1,8%) 142 / 6022 (2,4%) 0,77 [0,61;0,99]
    Not calculable (data not available)
    Nondisabling stroke 44 / 6076 (0,7%) 69 / 6022 (1,1%) 0,63 [0,43;0,92]
    Disabling or fatal stroke 80 / 6076 (1,3%) 118 / 6022 (2,0%) 0,67 [0,51;0,89]
    Myocardial infarction 89 / 6076 (1,5%) 63 / 6022 (1,0%) 1,40 [1,02;1,93]
    Pulmonary embolism 18 / 6076 (0,3%) 11 / 6022 (0,2%) 1,62 [0,77;3,43]
    Hospitalization 2430 / 6076 (40,0%) 2458 / 6022 (40,8%) 0,98 [0,94;1,02]
    Death from vascular causes 274 / 6076 (4,5%) 317 / 6022 (5,3%) 0,86 [0,73;1,00]
    Death from any cause 438 / 6076 (7,2%) 487 / 6022 (8,1%) 0,89 [0,79;1,01]
    Major bleeding 375 / 6076 (6,2%) 397 / 6022 (6,6%) 0,94 [0,82;1,07]
    Life threatening Major bleeding 175 / 6076 (2,9%) 212 / 6022 (3,5%) 0,82 [0,67;1,00]
    Non–life threatening Major bleeding 226 / 6076 (3,7%) 208 / 6022 (3,5%) 1,08 [0,90;1,30]
    Gastrointestinal Major bleeding 182 / 6076 (3,0%) 120 / 6022 (2,0%) 1,50 [1,20;1,89]
    Minor bleeding 1787 / 6076 (29,4%) 1931 / 6022 (32,1%) 0,92 [0,87;0,97]
    Major or minor bleeding 1977 / 6076 (32,5%) 2142 / 6022 (35,6%) 0,91 [0,87;0,96]
    Intracranial bleeding 36 / 6076 (0,6%) 87 / 6022 (1,4%) 0,41 [0,28;0,60]
    Extracranial bleeding 342 / 6076 (5,6%) 315 / 6022 (5,2%) 1,08 [0,93;1,25]
    Net clinical benefit 832 / 6076 (13,7%) 901 / 6022 (15,0%) 0,92 [0,84;1,00]

    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]

    Coronary event

    195 / 12091
    75 / 6022
    1,29 [0,99;1,69]

    thrombo-embolic event (cerebral or systemic)

    134 / 6076
    199 / 6022
    0,67 [0,54;0,83]

    systemic thrombo-embolic complication

    12 / 6076
    14 / 6022
    0,85 [0,39;1,84]

    stroke (fatal and non fatal)

    122 / 6076
    185 / 6022
    0,65 [0,52;0,82]

    ischemic stroke

    111 / 6076
    142 / 6022
    0,77 [0,61;0,99]

    myocardial infarction (fatal and non fatal)

    89 / 6076
    63 / 6022
    1,40 [1,02;1,93]

    All cause death

    438 / 6076
    487 / 6022
    0,89 [0,79;1,01]

    Bleeding

    1977 / 6076
    2142 / 6022
    0,91 [0,87;0,96]

    Major bleeding

    375 / 6076
    397 / 6022
    0,94 [0,82;1,07]

    Minor bleeding

    1787 / 6076
    1931 / 6022
    0,92 [0,87;0,97]

    Haemmorhagic stroke

    12 / 6076
    45 / 6022
    0,26 [0,14;0,50]

    Fatal bleeding

    175 / 6076
    212 / 6022
    0,82 [0,67;1,00]

    Gastrointestinal major bleeding

    182 / 6076
    120 / 6022
    1,50 [1,20;1,89]

    Cardiovascular death

    274 / 6076
    317 / 6022
    0,86 [0,73;1,00]

    Fatal stroke

    80 / 6076
    118 / 6022
    0,67 [0,51;0,89]

    Non-lifethreatening major bleeding

    226 / 6076
    208 / 6022
    1,08 [0,90;1,30]

    Lifethreatening major bleeding

    175 / 6076
    212 / 6022
    0,82 [0,67;1,00]

    Non fatal stroke

    44 / 6076
    69 / 6022
    0,63 [0,43;0,92]

    intracranial hemorrhage

    36 / 6076
    87 / 6022
    0,41 [0,28;0,60]
    0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial
    Ref
    Studied treat. Control treat.
    Coronary event 195 / 12091 (1,6%) 75 / 6022 (1,2%) 1,29 [0,99;1,69]   16949
    thrombo-embolic event (cerebral or systemic) 134 / 6076 (2,2%) 199 / 6022 (3,3%) 0,67 [0,54;0,83] Stroke or systemic embolism 
    systemic thrombo-embolic complication 12 / 6076 (0,2%) 14 / 6022 (0,2%) 0,85 [0,39;1,84] imputed  11169
    stroke (fatal and non fatal) 122 / 6076 (2,0%) 185 / 6022 (3,1%) 0,65 [0,52;0,82] Stroke 
    ischemic stroke 111 / 6076 (1,8%) 142 / 6022 (2,4%) 0,77 [0,61;0,99] Ischemic or unspecified  
    myocardial infarction (fatal and non fatal) 89 / 6076 (1,5%) 63 / 6022 (1,0%) 1,40 [1,02;1,93]   11169
    All cause death 438 / 6076 (7,2%) 487 / 6022 (8,1%) 0,89 [0,79;1,01] Death from any cause 
    Bleeding 1977 / 6076 (32,5%) 2142 / 6022 (35,6%) 0,91 [0,87;0,96] Major or minor bleeding 
    Major bleeding 375 / 6076 (6,2%) 397 / 6022 (6,6%) 0,94 [0,82;1,07] Major bleeding 
    Minor bleeding 1787 / 6076 (29,4%) 1931 / 6022 (32,1%) 0,92 [0,87;0,97] Minor bleeding 
    Haemmorhagic stroke 12 / 6076 (0,2%) 45 / 6022 (0,7%) 0,26 [0,14;0,50] Hemorrhagic 
    Fatal bleeding 175 / 6076 (2,9%) 212 / 6022 (3,5%) 0,82 [0,67;1,00] Life threatening Major bleeding  
    Gastrointestinal major bleeding 182 / 6076 (3,0%) 120 / 6022 (2,0%) 1,50 [1,20;1,89] Gastrointestinal Major bleeding  
    Cardiovascular death 274 / 6076 (4,5%) 317 / 6022 (5,3%) 0,86 [0,73;1,00] Death from vascular causes 
    Fatal stroke 80 / 6076 (1,3%) 118 / 6022 (2,0%) 0,67 [0,51;0,89] Disabling or fatal stroke 
    Non-lifethreatening major bleeding 226 / 6076 (3,7%) 208 / 6022 (3,5%) 1,08 [0,90;1,30] Non–life threatening Major bleeding  
    Lifethreatening major bleeding 175 / 6076 (2,9%) 212 / 6022 (3,5%) 0,82 [0,67;1,00] Life threatening Major bleeding  
    Non fatal stroke 44 / 6076 (0,7%) 69 / 6022 (1,1%) 0,63 [0,43;0,92] Nondisabling stroke 
    intracranial hemorrhage 36 / 6076 (0,6%) 87 / 6022 (1,4%) 0,41 [0,28;0,60] Intracranial bleeding 
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:
  • 11169: Connolly SJ, Ezekowitz MD, Yusuf S, Eikelboom J, Oldgren J, Parekh A, Pogue J, Reilly PA, Themeles E, Varrone J, Wang S, Alings M, Xavier D, Zhu J, Diaz R, Lewis BS, Darius H, Diener HC, Joyner CD, Wallentin LDabigatran versus warfarin in patients with atrial fibrillation.N Engl J Med 2009 Sep 17;361:1139-51
  • 16949: Mak KHCoronary and mortality risk of novel oral antithrombotic agents: a meta-analysis of large randomised trials.BMJ Open 2012;2:

  • Endpoint studied treat. control treat. mean diff

    Absolute risk reduction (for a follow-up of 2 y (median))
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    Coronary event 1,61% 1,25% 0,37%
    thrombo-embolic event (cerebral or systemic) 2,21% 3,30% -1,10%
    systemic thrombo-embolic complication 1,97‰ 2,32‰ -0,03%
    stroke (fatal and non fatal) 2,01% 3,07% -1,06%
    ischemic stroke 1,83% 2,36% -0,53%
    myocardial infarction (fatal and non fatal) 1,46% 1,05% 0,42%
    All cause death 7,21% 8,09% -0,88%
    Bleeding 32,54% 35,57% -3,03%
    Major bleeding 6,17% 6,59% -0,42%
    Minor bleeding 29,41% 32,07% -2,65%
    Haemmorhagic stroke 1,97‰ 7,47‰ -0,55%
    Fatal bleeding 2,88% 3,52% -0,64%
    Gastrointestinal major bleeding 3,00% 1,99% 1,0%
    Cardiovascular death 4,51% 5,26% -0,75%
    Fatal stroke 1,32% 1,96% -0,64%
    Non-lifethreatening major bleeding 3,72% 3,45% 0,27%
    Lifethreatening major bleeding 2,88% 3,52% -0,64%
    Non fatal stroke 7,24‰ 1,15% -0,42%
    intracranial hemorrhage 5,92‰ 1,44% -0,85%

    Meta-analysis of all similar trials:

    antithrombotics in atrial fibrillation for primary prevention of thromboembolic events

    direct antithrombins in atrial fibrillation for all type of patients

    new oral anticoagulants in atrial fibrillation for all type of patients



    Reference(s)

    TrialResults-center ID TRC7218
    Trials register # NCT00262600
    Study web site link ,
    • Ezekowitz MD, Connolly S, Parekh A, Reilly PA, Varrone J, Wang S, Oldgren J, Themeles E, Wallentin L, Yusuf S. Rationale and design of RE-LY: randomized evaluation of long-term anticoagulant therapy, warfarin, compared with dabigatran.. Am Heart J 2009;157:805-10, 810.e1-2
      Pubmed | Hubmed | Fulltext
    • Connolly SJ, Ezekowitz MD, Yusuf S, Eikelboom J, Oldgren J, Parekh A, Pogue J, Reilly PA, Themeles E, Varrone J, Wang S, Alings M, Xavier D, Zhu J, Diaz R, Lewis BS, Darius H, Diener HC, Joyner CD, Wallentin L. Dabigatran versus warfarin in patients with atrial fibrillation.. N Engl J Med 2009 Sep 17;361:1139-51 - 10.1056/NEJMoa0905561
      Pubmed | Hubmed | Fulltext

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