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See also:

  • All DVT prophylaxis clinical trials
  • All clinical trials of new anticoagulants
  • All clinical trials of dabigatran 150mg
    		•  

    RE-MODEL (150mg) study, 2007

    Facebook    pdf : dabigatran 150mg - antithrombotics for DVT prophylaxis

    Treatments

    Studied treatment dabigatran etexilate 150 mg q.d. for 6-10 days
    administered 1�4 h after completion of surgery
    Control treatment Enoxaparin 40 mg q.d. for 6-10 days
    started on the evening before surgery
    Treatments description
    enoxaprin regimen started before surgery  
    treatment duration 6-10 days 

    Patients

    Patients Total knee replacement
    Inclusion criteria Patients <=18 years; >40 kg; scheduled for primary elective unilateral total knee replacement
    Exclusion criteria any bleeding diathesis; history of acute intracranial disease or hemorrhagic stroke; major surgery, trauma, uncontrolled hypertension or myocardial infarction within the past 3 months; gastrointestinal or urogenital bleeding or ulcer disease within the past 6 months; severe liver disease; aspartate aminotransferase or alanine aminotransferase (ALT) levels more than two times the upper limit of the normal range (ULN) within the past month; severe renal insufficiency (creatinine clearance <30 mL/min); concomitant long-acting non-steroidal anti-inflammatory drug therapy (also contraindicated during study treatment); active malignant disease
    Baseline characteristics
    Age (mean), years 68y 
    Total hip replacement 0% 
    Total knee replacement 100% 
    Weight, kg, 82 kg 
    Female 67% 
    general anesthesia 23% 
    BMI (kg/m�) NA 
    History of venous thromboembolism (%) NA 
    Use of cement NA 
    Estimated creatinine clearance >60 ml/min NA 
    Previous orthopedic surgery (%) NA 
    Duration of surgery (min) 91 min 

    Method and design

    Randomized effectives 708 / 699 (studied vs. control)
    Design Parallel groups
    Blinding double blind
    Follow-up duration 6-10 days, mean 8 days
    Number of centre 105
    Geographic area Europe, Australia, South Africa
    Hypothesis Non inferiority
    Primary endpoint total VTE and all-cause mortality
    Remarks

    Remarks / Comments



    Results

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

    major or clinically relevant non-major bleeding

    57 / 703
         46 / 694
         1,22 [0,84;1,78]

    All cause death

    1 / 696
         1 / 685
         classic 0,98 [0,06;15,70]

    asymptomatic DVT

    208 / 526
         184 / 512
         1,10 [0,94;1,29]

    non-fatal pulmonary embolism

    1 / 526
         0 / 512
         classic 4,87 [0,07;355,98]

    proximal DVT

    18 / 526
         17 / 512
         1,03 [0,54;1,98]

    Major bleeding

    9 / 703
         9 / 694
         classic 0,99 [0,39;2,47]

    total VTE and all-cause mortality

    213 / 526
         193 / 512
         1,07 [0,92;1,25]

    Symptomatic deep-vein thrombosis

    3 / 526
         8 / 512
         0,37 [0,10;1,37]

    distal DVT

    193 / 526
         175 / 512
         1,07 [0,91;1,27]

    major VTE (fatal and non fatal DVT,PE)

    20 / 527
         18 / 511
         classic 1,08 [0,58;2,01]     0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial    		 Ref
    Studied treat. Control treat.
    major or clinically relevant non-major bleeding 57 / 703 (8,1%) 46 / 694 (6,6%) 1,22 [0,84;1,78]   12100 
    All cause death 1 / 696 (0,1%) 1 / 685 (0,1%) 0,98 [0,06;15,70]   12100 
    asymptomatic DVT 208 / 526 (39,5%) 184 / 512 (35,9%) 1,10 [0,94;1,29]    
    non-fatal pulmonary embolism 1 / 526 (0,2%) 0 / 512 (0,1%) 1,95 [0,07;57,91]    
    proximal DVT 18 / 526 (3,4%) 17 / 512 (3,3%) 1,03 [0,54;1,98]    
    Major bleeding 9 / 703 (1,3%) 9 / 694 (1,3%) 0,99 [0,39;2,47]   12100 
    total VTE and all-cause mortality 213 / 526 (40,5%) 193 / 512 (37,7%) 1,07 [0,92;1,25]    
    Symptomatic deep-vein thrombosis 3 / 526 (0,6%) 8 / 512 (1,6%) 0,37 [0,10;1,37]    
    distal DVT 193 / 526 (36,7%) 175 / 512 (34,2%) 1,07 [0,91;1,27]    
    major VTE (fatal and non fatal DVT,PE) 20 / 527 (3,8%) 18 / 511 (3,5%) 1,08 [0,58;2,01]   12100 
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:
  • 12100: Eriksson BI, Dahl OE, Rosencher N, Kurth AA, van Dijk CN, Frostick SP, K�lebo P, Christiansen AV, Hantel S, Hettiarachchi R, Schnee J, B�ller HROral dabigatran etexilate vs. subcutaneous enoxaparin for the prevention of venous thromboembolism after total knee replacement: the RE-MODEL randomized trial.J Thromb Haemost 2007;5:2178-85

    • Endpoint studied treat. control treat. mean diff

    Absolute risk reduction
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    major or clinically relevant non-major bleeding 8,11% 6,63% 1,5%
    All cause death 1,44‰ 1,46‰ -0,0‰
    asymptomatic DVT 39,54% 35,94% 3,6%
    proximal DVT 3,42% 3,32% 1,0‰
    Major bleeding 1,28% 1,30% -0,2‰
    total VTE and all-cause mortality 40,49% 37,70% 2,8%
    Symptomatic deep-vein thrombosis 5,70‰ 1,56% -9,9‰
    distal DVT 36,69% 34,18% 2,5%
    major VTE (fatal and non fatal DVT,PE) 3,80% 3,52% 2,7‰

    Meta-analysis of all similar trials:

    anticoagulant in DVT prophylaxis for orthopedic surgery

    antithrombotics in DVT prophylaxis for elective major knee surgery

    antithrombotics in DVT prophylaxis for orthopedic surgery

    direct antithrombins in DVT prophylaxis for all type of patients

    new anticoagulants in DVT prophylaxis for elective major knee surgery

    new anticoagulants in DVT prophylaxis for orthopaedic surgery

    new anticoagulants in DVT prophylaxis for all type of patients



    Reference(s)

    Trials register # NA
    • Eriksson BI, Dahl OE, Rosencher N, Kurth AA, van Dijk CN, Frostick SP, K�lebo P, Christiansen AV, Hantel S, Hettiarachchi R, Schnee J, B�ller HR. Oral dabigatran etexilate vs. subcutaneous enoxaparin for the prevention of venous thromboembolism after total knee replacement: the RE-MODEL randomized trial.. J Thromb Haemost 2007;5:2178-85 - 10.1111/j.1538-7836.2007.02748.x
      Pubmed | Hubmed | Fulltext

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