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See also:

  • All pulmonary embolism clinical trials
  • All venous thrombosis clinical trials
    		•  

    MATISSE PE study, 2003

    Treatments

    Studied treatment fondaparinux subcutaneously once daily
    fondaparinux (5.0, 7.5, or 10.0 mg in patients weighing less than 50, 50 to 100, or more than 100 kg, respectively) subcutaneously once daily, given for at least five days and until the use of vitamin K antagonists resulted in an international normalized ratio above 2.0
    Control treatment continuous intravenous infusion of unfractionated heparin
    (ratio of the activated partial-thromboplastin time to a control value, 1.5 to 2.5), given for at least five days and until the use of vitamin K antagonists resulted in an international normalized ratio above 2.0

    Patients

    Patients patients with acute symptomatic pulmonary embolism
    Inclusion criteria patients 18 years of age or older who presented with acute symptomatic pulmonary embolism and who required antithrombotic therapy were potentially eligible for the study. Diagnostic criteria were an intraluminal filling defect on spiral computed tomography (CT) or pulmonary angiography, a high-probability ventilation�perfusion lung scan, or a nondiagnostic lung scan with documentation of deep-vein thrombosis either by compression ultrasonography or by venography
    Baseline characteristics
    Age 62.5y 
    female (%) 27.2% 

    Method and design

    Randomized effectives 1103 / 1110 (studied vs. control)
    Design Parallel groups
    Blinding open
    Follow-up duration 3 mo
    Number of centre 235
    Primary endpoint symptomatic recurrent/new VTE


    Results

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

    Recurrent thromboembolic event

    42 / 1103
         56 / 1110
         0,75 [0,51;1,12]

    All cause death

    57 / 1092
         48 / 1092
         1,19 [0,82;1,73]

    Major bleeding

    22 / 1092
         26 / 1092
         0,85 [0,48;1,48]     0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial
    Studied treat. Control treat.
    Recurrent thromboembolic event 42 / 1103 (3,8%) 56 / 1110 (5,0%) 0,75 [0,51;1,12] entire study  
    Major bleeding 22 / 1092 (2,0%) 26 / 1092 (2,4%) 0,85 [0,48;1,48]  
    All cause death 57 / 1092 (5,2%) 48 / 1092 (4,4%) 1,19 [0,82;1,73]  
    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 3,81% 5,05% -12,4‰
    Major bleeding 2,01% 2,38% -3,7‰
    All cause death 5,22% 4,40% 8,2‰


    Reference(s)

    Trials register # NA
    • B�ller HR, Davidson BL, Decousus H, Gallus A, Gent M, Piovella F, Prins MH, Raskob G, van den Berg-Segers AE, Cariou R, Leeuwenkamp O, Lensing AW. Subcutaneous fondaparinux versus intravenous unfractionated heparin in the initial treatment of pulmonary embolism.. N Engl J Med 2003 Oct 30;349:1695-702
      Pubmed | Hubmed | Fulltext

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