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Systematic review and meta-analysis

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

venous thrombosis - caval filter - all type of patients  


Related trials

PREPIC, 1998 - caval filter vs no filter



See also:

  • All venous thrombosis clinical trials
  • All clinical trials of caval filter
  • All clinical trials of caval filter
  •  

    PREPIC study, 1998

    Treatments

    Studied treatment caval filter
    Control treatment no filter
    Remarks 2x2 factorial design also comparing LMWH vs unfractionated heparin

    Patients

    Patients patients with documented proximal DVT or PE, and considered high risk for pulmonary embolism
    Exclusion criteria previous filter; contraindication or failure of anticoagulation; curative anticoagulation > 48 hours duration; indication for thrombolysis; short life expectancy; allergy to iodine; hereditary thrombophilia; severe renal or hepatic failure; pregnancy; likely non-compliance

    Method and design

    Randomized effectives 200 / 200 (studied vs. control)
    Design Parallel groups
    Blinding open
    Follow-up duration 12 days and 2 years
    Primary endpoint none


    Results

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

    asymptomatic pulmonary embolism

    0 / 200
    4 / 200
    classic 0,06 [0,00;3,31]

    Major bleeding

    9 / 200
    6 / 200
    classic 1,50 [0,54;4,14]

    symptomatic pulmonary embolism

    2 / 200
    5 / 200
    classic 0,40 [0,08;2,04]

    pulmonary embolism (symptomatic and asymptomatic)

    NA / 200
    NA / 200
    0,22 [0,05;0,93]

    All cause death

    5 / 200
    5 / 200
    classic 1,00 [0,29;3,40]
    0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial
    Ref
    Studied treat. Control treat.
    asymptomatic pulmonary embolism 0 / 200 (0,3%) 4 / 200 (2,0%) 0,13 [0,01;2,35]  
    Major bleeding 9 / 200 (4,5%) 6 / 200 (3,0%) 1,50 [0,54;4,14]  
    symptomatic pulmonary embolism 2 / 200 (1,0%) 5 / 200 (2,5%) 0,40 [0,08;2,04]  
    pulmonary embolism (symptomatic and asymptomatic) 2 / 200 (1,0%) 9 / 200 (4,5%) 0,22 [0,05;1,02] odds ratio 
    All cause death 5 / 200 (2,5%) 5 / 200 (2,5%) 1,00 [0,29;3,40]  
    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
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    Major bleeding 4,50% 3,00% 1,5%
    symptomatic pulmonary embolism 1,00% 2,50% -15,0‰
    pulmonary embolism (symptomatic and asymptomatic) 1,00% 4,50% -35,0‰
    All cause death 2,50% 2,50% 0,0‰


    Reference(s)

    Trials register # NA
    • Decousus H, Leizorovicz A, Parent F, Page Y, Tardy B, Girard P, Laporte S, Faivre R, Charbonnier B, Barral FG, Huet Y, Simonneau G. A clinical trial of vena caval filters in the prevention of pulmonary embolism in patients with proximal deep-vein thrombosis. Prévention du Risque d'Embolie Pulmonaire par Interruption Cave Study Group.. N Engl J Med 1998;338:409-15
      Pubmed | Hubmed | Fulltext
    • . Eight-year follow-up of patients with permanent vena cava filters in the prevention of pulmonary embolism: the PREPIC (Prevention du Risque d'Embolie Pulmonaire par Interruption Cave) randomized study.. Circulation 2005;112:416-22
      Pubmed | Hubmed | Fulltext

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