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See also:

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

    RE-MOBILIZE (220mg) study, 2008

    Facebook    pdf : dabigatran 220mg - antithrombotics for DVT prophylaxis

    Treatments

    Studied treatment dabigatran etexilate 220 mg for 12-15 days
    started 6 to 12 hours after completion of surgery
    Control treatment Enoxaparin 30mg SC BID after surgery for 12-15 days
    started 12 to 24 hours after surgery, usually on the morning after the day of surgery
    Concomittant treatment
    Remarks
    Treatments description
    enoxaprin regimen started after surgery 
    treatment duration 12-15 days 

    Patients

    Patients Total knee replacement
    Inclusion criteria Patients 18 years or older and weighing more than 40 kg who had undergone primary elective unilateral total knee arthroplasty
    Exclusion criteria known inherited or acquired clinically significant bleeding disorder; major surgery, trauma, uncontrolled hypertension, or myocardial infarction within the last 3 months; history of acute intracranial disease or hemorrhagic stroke; gastrointestinal or urogenital bleeding or ulcer disease within the last 6 months; severe liver disease; aspartate or alanine aminotransferase (AST, ALT) levels higher than 2x the upper limit of the normal range (ULN) within the last month; severe renal insufficiency (creatinine clearance <30 mL/min); need for concomitant longacting nonsteroidal anti-inflammatory drug therapy or treatment with an anticoagulant during study drug treatment; active malignant disease; platelet count less than 100 × 10^9/L,
    Remarks
    Baseline characteristics
    Age (mean), years 66y 
    Total hip replacement 0% 
    Total knee replacement 100% 
    Weight, kg, 88kg 
    Female 57% 
    general anesthesia 53% 
    BMI (kg/m²) NA 
    History of venous thromboembolism (%) NA 
    Use of cement NA 
    Estimated creatinine clearance >60 ml/min NA (mean clearance 82.9 ml/min) 
    Previous orthopedic surgery (%) NA 
    Duration of surgery (min) 91 min 

    Method and design

    Randomized effectives 862 / 876 (studied vs. control)
    Design Parallel groups
    Blinding double blind
    Follow-up duration 12-15 days, median 14d
    Number of centre 97
    Geographic area US, Canada, Mexico, UK
    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

    28 / 857
    33 / 868
    0,86 [0,52;1,41]

    distal DVT

    167 / 604
    148 / 643
    1,20 [0,99;1,45]

    major VTE (fatal and non fatal DVT,PE)

    21 / 618
    15 / 668
    classic 1,51 [0,79;2,91]

    total VTE and all-cause mortality

    188 / 604
    163 / 643
    1,23 [1,03;1,47]

    proximal DVT

    14 / 604
    10 / 643
    classic 1,49 [0,67;3,33]

    Major bleeding

    5 / 857
    12 / 868
    0,42 [0,15;1,19]
    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 28 / 857 (3,3%) 33 / 868 (3,8%) 0,86 [0,52;1,41]   7601 
    proximal DVT 14 / 604 (2,3%) 10 / 643 (1,6%) 1,49 [0,67;3,33]   7601 
    Major bleeding 5 / 857 (0,6%) 12 / 868 (1,4%) 0,42 [0,15;1,19]   7601 
    total VTE and all-cause mortality 188 / 604 (31,1%) 163 / 643 (25,3%) 1,23 [1,03;1,47]   7601 
    distal DVT 167 / 604 (27,6%) 148 / 643 (23,0%) 1,20 [0,99;1,45]   7601 
    major VTE (fatal and non fatal DVT,PE) 21 / 618 (3,4%) 15 / 668 (2,2%) 1,51 [0,79;2,91]   7601 
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:
  • 7601: The Oral Thrombin Inhibitor Dabigatran Etexilate vs the North American Enoxaparin Regimen for the Prevention of Venous Thromboembolism after Knee Arthroplasty Surgery.J Arthroplasty 2008;:

  • 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 3,27% 3,80% -5,3‰
    proximal DVT 2,32% 1,56% 7,6‰
    Major bleeding 5,83‰ 1,38% -8,0‰
    total VTE and all-cause mortality 31,13% 25,35% 5,8%
    distal DVT 27,65% 23,02% 4,6%
    major VTE (fatal and non fatal DVT,PE) 3,40% 2,25% 1,2%

    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
    • . The Oral Thrombin Inhibitor Dabigatran Etexilate vs the North American Enoxaparin Regimen for the Prevention of Venous Thromboembolism after Knee Arthroplasty Surgery.. J Arthroplasty 2008;:
      Pubmed | Hubmed | Fulltext

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