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See also:

  • All DVT prophylaxis clinical trials
  • All clinical trials of new anticoagulants
  • All clinical trials of dabigatran 220mg
  •  

    RE-MODEL (220mg) study, 2007

    Facebook    pdf : dabigatran 220mg - antithrombotics for DVT prophylaxis

    Treatments

    Studied treatment dabigatran etexilate 220 mg q.d. 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/m²) 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) 90 min 

    Method and design

    Randomized effectives 694 / 699 (studied vs. control)
    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]

    All cause death

    1 / 675
    1 / 685
    classic 1,01 [0,06;16,19]

    major or clinically relevant non-major bleeding

    50 / 679
    46 / 694
    1,11 [0,76;1,63]

    asymptomatic DVT

    181 / 503
    184 / 512
    1,00 [0,85;1,18]

    distal DVT

    168 / 503
    168 / 511
    1,02 [0,85;1,21]

    major VTE (fatal and non fatal DVT,PE)

    13 / 506
    18 / 511
    0,73 [0,36;1,47]

    total VTE and all-cause mortality

    183 / 503
    193 / 512
    0,97 [0,82;1,13]

    Symptomatic deep-vein thrombosis

    1 / 675
    8 / 685
    0,13 [0,02;1,01]

    proximal DVT

    13 / 503
    16 / 510
    0,82 [0,40;1,69]

    Major bleeding

    10 / 679
    9 / 694
    classic 1,14 [0,46;2,78]
    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 50 / 679 (7,4%) 46 / 694 (6,6%) 1,11 [0,76;1,63]   7389 
    All cause death 1 / 675 (0,1%) 1 / 685 (0,1%) 1,01 [0,06;16,19]   7389 
    asymptomatic DVT 181 / 503 (36,0%) 184 / 512 (35,9%) 1,00 [0,85;1,18]    
    proximal DVT 13 / 503 (2,6%) 16 / 510 (3,1%) 0,82 [0,40;1,69]    
    Major bleeding 10 / 679 (1,5%) 9 / 694 (1,3%) 1,14 [0,46;2,78]   7389 
    total VTE and all-cause mortality 183 / 503 (36,4%) 193 / 512 (37,7%) 0,97 [0,82;1,13]    
    Symptomatic deep-vein thrombosis 1 / 675 (0,1%) 8 / 685 (1,2%) 0,13 [0,02;1,01]    
    distal DVT 168 / 503 (33,4%) 168 / 511 (32,9%) 1,02 [0,85;1,21]   7389 
    major VTE (fatal and non fatal DVT,PE) 13 / 506 (2,6%) 18 / 511 (3,5%) 0,73 [0,36;1,47]   7389 
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:
  • 7389: Eriksson BI, Dahl OE, Rosencher N, Kurth AA, van Dijk CN, Frostick SP, Kälebo P, Christiansen AV, Hantel S, Hettiarachchi R, Schnee J, Büller 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 Nov;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 7,36% 6,63% 7,4‰
    All cause death 1,48‰ 1,46‰ 0,0‰
    asymptomatic DVT 35,98% 35,94% 0,5‰
    proximal DVT 2,58% 3,14% -5,5‰
    Major bleeding 1,47% 1,30% 1,8‰
    total VTE and all-cause mortality 36,38% 37,70% -13,1‰
    Symptomatic deep-vein thrombosis 1,48‰ 1,17% -10,2‰
    distal DVT 33,40% 32,88% 5,2‰
    major VTE (fatal and non fatal DVT,PE) 2,57% 3,52% -9,5‰

    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, Kälebo P, Christiansen AV, Hantel S, Hettiarachchi R, Schnee J, Büller 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 Nov;5:2178-85
      Pubmed | Hubmed | Fulltext

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