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See also:

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

    RE-NOVATE (220mg) study, 2007

    [NCT00168818] Facebook    pdf : dabigatran 220mg - antithrombotics for DVT prophylaxis

    Treatments

    Studied treatment dabigatran etexilate 220 mg q.d. for 28-35 days
    starting the evening before surgery
    Control treatment Enoxaparin 40 mg q.d. for 23-35 days
    Remarks 3 arms dabigatran 220mg, 150mg and placebo
    Treatments description
    enoxaprin regimen started before surgery  
    treatment duration 28-35 days 

    Patients

    Patients Total hip replacement
    Inclusion criteria aged 18 years or older; weight at least 40 kg; scheduled for primary elective unilateral total hip replacement
    Exclusion criteria any bleeding diathesis; history of acute intracranial disease or haemorrhagic stroke; major surgery, trauma, uncontrolled hypertension, or myocardial infarction in the past 3 months; gastrointestinal or urogenital bleeding, or ulcer disease in the past 6 months; severe liver disease; alanine or aspartate aminotransferase concentrations greater than two times the upper limit of the normal range in the past month; severe renal insuffi ciency (creatinine clearance less than 30 mL/min); use of long-acting non-steroidal anti-infl ammatory drugs
    Baseline characteristics
    Age (mean), years 64y 
    Total hip replacement 100% 
    Total knee replacement 0% 
    Weight, kg, 79 kg 
    Female 56% 
    general anesthesia 25% 
    BMI (kg/m²) NA 
    History of venous thromboembolism (%) 3% 
    Use of cement NA 
    Estimated creatinine clearance >60 ml/min NA (mean 89 ml/min) 
    Previous orthopedic surgery (%) NA 
    Duration of surgery (min) 86 min 

    Method and design

    Randomized effectives 1157 / 1162 (studied vs. control)
    Design Parallel groups
    Blinding double blind
    Follow-up duration 28-35 days, median 33d
    Number of centre 115
    Geographic area Europe, Australia, South Africa
    Primary endpoint total VTE and all-cause mortality


    Results

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

    All cause death

    3 / 1137
    0 / 1142
    classic 13,06 [0,22;762,41]

    asymptomatic DVT

    40 / 880
    56 / 897
    0,73 [0,49;1,08]

    non-fatal pulmonary embolism

    5 / 880
    3 / 897
    classic 1,70 [0,41;7,09]

    proximal DVT

    18 / 905
    32 / 914
    0,57 [0,32;1,00]

    Major bleeding

    23 / 1146
    18 / 1154
    classic 1,29 [0,70;2,37]

    total VTE and all-cause mortality

    53 / 880
    60 / 897
    0,90 [0,63;1,29]

    Symptomatic deep-vein thrombosis

    6 / 1137
    1 / 1142
    classic 6,03 [0,73;49,98]

    distal DVT

    22 / 874
    24 / 894
    0,94 [0,53;1,66]

    major VTE (fatal and non fatal DVT,PE)

    28 / 909
    36 / 917
    0,78 [0,48;1,27]
    0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial
    Ref
    Studied treat. Control treat.
    All cause death 3 / 1137 (0,3%) 0 / 1142 (0,0%) 6,03 [0,30;120,18]   7390 
    asymptomatic DVT 40 / 880 (4,5%) 56 / 897 (6,2%) 0,73 [0,49;1,08]    
    non-fatal pulmonary embolism 5 / 880 (0,6%) 3 / 897 (0,3%) 1,70 [0,41;7,09]    
    proximal DVT 18 / 905 (2,0%) 32 / 914 (3,5%) 0,57 [0,32;1,00] asymptomatic   
    Major bleeding 23 / 1146 (2,0%) 18 / 1154 (1,6%) 1,29 [0,70;2,37]    
    total VTE and all-cause mortality 53 / 880 (6,0%) 60 / 897 (6,7%) 0,90 [0,63;1,29] during treatment period   
    Symptomatic deep-vein thrombosis 6 / 1137 (0,5%) 1 / 1142 (0,1%) 6,03 [0,73;49,98]   7390 
    distal DVT 22 / 874 (2,5%) 24 / 894 (2,7%) 0,94 [0,53;1,66] asymptomatic distal   
    major VTE (fatal and non fatal DVT,PE) 28 / 909 (3,1%) 36 / 917 (3,9%) 0,78 [0,48;1,27]    
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:
  • 7390: Eriksson BI, Dahl OE, Rosencher N, Kurth AA, van Dijk CN, Frostick SP, Prins MH, Hettiarachchi R, Hantel S, Schnee J, Büller HRDabigatran etexilate versus enoxaparin for prevention of venous thromboembolism after total hip replacement: a randomised, double-blind, non-inferiority trial.Lancet 2007;370:949-56

  • Endpoint studied treat. control treat. mean diff

    Absolute risk reduction
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    asymptomatic DVT 4,55% 6,24% -17,0‰
    non-fatal pulmonary embolism 5,68‰ 3,34‰ 2,3‰
    proximal DVT 1,99% 3,50% -15,1‰
    Major bleeding 2,01% 1,56% 4,5‰
    total VTE and all-cause mortality 6,02% 6,69% -6,7‰
    Symptomatic deep-vein thrombosis 5,28‰ 0,88‰ 4,4‰
    distal DVT 2,52% 2,68% -1,7‰
    major VTE (fatal and non fatal DVT,PE) 3,08% 3,93% -8,5‰

    Meta-analysis of all similar trials:

    anticoagulant in DVT prophylaxis for orthopedic surgery

    antithrombotics in DVT prophylaxis for elective hip replacement

    antithrombotics in DVT prophylaxis for orthopedic surgery

    direct antithrombins in DVT prophylaxis for all type of patients

    new anticoagulants in DVT prophylaxis for elective hip replacement

    new anticoagulants in DVT prophylaxis for orthopaedic surgery

    new anticoagulants in DVT prophylaxis for all type of patients



    Reference(s)

    Trials register # NCT00168818
    • Eriksson BI, Dahl OE, Rosencher N, Kurth AA, van Dijk CN, Frostick SP, Prins MH, Hettiarachchi R, Hantel S, Schnee J, Büller HR. Dabigatran etexilate versus enoxaparin for prevention of venous thromboembolism after total hip replacement: a randomised, double-blind, non-inferiority trial.. Lancet 2007;370:949-56
      Pubmed | Hubmed | Fulltext

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