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See also:

  • All pulmonary embolism clinical trials
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  •  

    VanGogh PE study, 2007

    [NCT00062803]

    Treatments

    Studied treatment subcutaneous idraparinux (2.5 mg once weekly)
    Control treatment heparin followed by an adjusted-dose vitamin K antagonist

    Patients

    Patients patients with pulmonary embolism
    Inclusion criteria intraluminal filling defect in subsegmental or more proximal pulmonary arteries on spiral computed tomography (CT) or pulmonary angiography, a high-probability finding on a ventilation–perfusion lung scan, or a nondiagnostic finding with documented deep venous thrombosis. Patients without chest symptoms in whom deep venous thrombosis was diagnosed were not routinely tested for pulmonary embolism.
    Exclusion criteria therapeutic dose of low-molecular-weight heparin or unfractionated heparin administered for more than 36 hours before randomization; thrombolysis, embolectomy, or vena cava filter required for the current episode; another indication for a vitamin K antagonist; pregnancy or breast-feeding; creatinine clearance of less than 10 ml per minute; uncontrolled hypertension (systolic blood pressure >180 mm Hg or diastolic blood pressure >110 mm Hg); life expectancy of less than 3 months.
    Baseline characteristics
    Age 61.9 y 
    female (%) 52% 
    Time from onset of symptoms 8.3 days 
    cancer (%) 14.5 % 
    Immobilization (%) 3% 
    Surgery or trauma (%) 4.3% 

    Method and design

    Randomized effectives 1095 / 1120 (studied vs. control)
    Design Parallel groups
    Blinding open
    Follow-up duration 3 mo (6 mo)
    Hypothesis Non inferiority
    Primary endpoint 3-month incidence of symptomatic recurrent venous thromboembolism (nonfatal or fatal)
    Remarks

    Remarks / Comments



    Results

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

    Recurrent thromboembolic event

    37 / 1095
    18 / 1120
    classic 2,10 [1,20;3,67]

    All cause death

    56 / 1095
    32 / 1120
    classic 1,79 [1,17;2,74]

    Major bleeding

    12 / 1095
    24 / 1120
    0,51 [0,26;1,02]
    0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial
    Studied treat. Control treat.
    Recurrent thromboembolic event 37 / 1095 (3,4%) 18 / 1120 (1,6%) 2,10 [1,20;3,67] at day 92 
    Major bleeding 12 / 1095 (1,1%) 24 / 1120 (2,1%) 0,51 [0,26;1,02] any clinically relevant bleeding at day 92 
    All cause death 56 / 1095 (5,1%) 32 / 1120 (2,9%) 1,79 [1,17;2,74] at day 92 
    The primary endpoint (if exists) appears in blod characters

    Endpoint studied treat. control treat. mean diff

    Absolute risk reduction
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    Recurrent thromboembolic event 3,38% 1,61% 1,8%
    Major bleeding 1,10% 2,14% -10,5‰
    All cause death 5,11% 2,86% 2,3%


    Reference(s)

    Trials register # NCT00062803
    • Buller HR, Cohen AT, Davidson B, Decousus H, Gallus AS, Gent M, Pillion G, Piovella F, Prins MH, Raskob GE. . N Engl J Med 2007 Sep 13;357:1094-104
      Pubmed | Hubmed | Fulltext

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