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See also:

  • All DVT prophylaxis clinical trials
  • All clinical trials of new oral anticoagulant
  • All clinical trials of dabigatran 450mg
    		•  

    BISTRO II (225mg bid) study, 2005

    Treatments

    Studied treatment dabigatran etexilate 225 mg twice daily for 6–10 days
    6–10 days starting 12h prior to surgery
    Control treatment subcutaneous enoxaparin 40 mg once daily
    6–10 days starting 12h prior to surgery
    Remarks dose finding study dabigatran (50,150 mg twice daily, 300 mg once daily, 225 mg twice daily) and enoxaparin
    Treatments description
    enoxaprin regimen started before surgery  
    treatment duration 6-10 days 

    Patients

    Patients patients undergoing total hip or knee replacement
    Baseline characteristics
    Age (mean), years 65.9y (range 20-93) 
    Total hip replacement 31% 
    Total knee replacement 67% 
    Weight, kg, 79kg (range 43-130) 
    Female 61.1% 
    general anesthesia 27% 

    Method and design

    Randomized effectives 393 / 392 (studied vs. control)
    Design Parallel groups
    Blinding double blind
    Number of centre 62
    Geographic area Europe and South Africa (2 centres)
    Hypothesis Superiority


    Results

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

    distal DVT

    36 / 297
         67 / 300
         0,54 [0,37;0,79]

    total VTE and all-cause mortality

    39 / 297
         72 / 300
         0,55 [0,38;0,78]

    proximal DVT

    5 / 297
         17 / 300
         0,30 [0,11;0,79]     0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial    		 Ref
    Studied treat. Control treat.
    proximal DVT 5 / 297 (1,7%) 17 / 300 (5,7%) 0,30 [0,11;0,79]    
    total VTE and all-cause mortality 39 / 297 (13,1%) 72 / 300 (24,0%) 0,55 [0,38;0,78]    
    distal DVT 36 / 297 (12,1%) 67 / 300 (22,3%) 0,54 [0,37;0,79]    
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:

    Endpoint studied treat. control treat. mean diff

    Absolute risk reduction
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    proximal DVT 1,68% 5,67% -39,8‰
    total VTE and all-cause mortality 13,13% 24,00% -108,7‰
    distal DVT 12,12% 22,33% -102,1‰


    Reference(s)

    Trials register # NA
    • Eriksson BI, Dahl OE, Büller HR, Hettiarachchi R, Rosencher N, Bravo ML, Ahnfelt L, Piovella F, Stangier J, Kälebo P, Reilly P. A new oral direct thrombin inhibitor, dabigatran etexilate, compared with enoxaparin for prevention of thromboembolic events following total hip or knee replacement: the BISTRO II randomized trial.. J Thromb Haemost 2005 Jan;3:103-11
      Pubmed | Hubmed | Fulltext

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