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See also:

  • All DVT prophylaxis clinical trials
  • All clinical trials of new anticoagulants
  • All clinical trials of rivaroxaban
  •  

    RECORD 3 study, 2008

    [NCT00361894] Facebook    pdf : rivaroxaban - antithrombotics for DVT prophylaxis

    Treatments

    Studied treatment rivaroxaban 10 mg once daily for 10- 14 days
    beginning 6 to 8 hours after surgery
    Control treatment enoxaparin 40 mg subcutaneous once daily
    beginning 12 hours before surgery
    Treatments description
    enoxaprin regimen started before surgery  
    treatment duration 10-14 days 

    Patients

    Patients patients undergoing total knee arthroplasty
    Inclusion criteria 18 years of age or older; scheduled for total knee arthroplasty
    Exclusion criteria active bleeding or a high risk of bleeding that contraindicated the use of low-molecular-weight heparin; any contraindication to the use of enoxaparin; or necessitating adjustment of its dose;conditions preventing bilateral venography, clinically significant liver disease, concomitant use of protease inhibitors of the human immunodeficiency virus or fibrinolytic agents; planned intermittent pneumatic compression; requirement of ongoing anticoagulant therapy; pregnancy or breast-feeding
    Baseline characteristics
    Age (mean), years 67.6y 
    Total hip replacement 0% 
    Total knee replacement 100% 
    Weight, kg, 80.65 
    Female 68.23 
    general anesthesia 33.9% 

    Method and design

    Randomized effectives 1254 / 1277 (studied vs. control)
    Design Parallel groups
    Blinding double blind
    Follow-up duration 13-17 days
    Number of centre 147 centers
    Geographic area 19 countries worldwide
    Hypothesis Superiority
    Primary endpoint DVT, PE all cause mortality


    Results

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

    All cause death

    0 / 1201
    6 / 1217
    classic 0,04 [0,00;2,21]

    non-fatal pulmonary embolism

    0 / 824
    2 / 878
    classic 0,12 [0,00;7,37]

    proximal DVT

    9 / 824
    20 / 878
    0,48 [0,22;1,05]

    Major bleeding

    7 / 1254
    6 / 1277
    classic 1,19 [0,40;3,53]

    Symptomatic venous thromboembolism (DVT, PE)

    8 / 1201
    24 / 1217
    0,34 [0,15;0,75]

    total VTE and all-cause mortality

    79 / 824
    166 / 878
    0,51 [0,39;0,65]

    distal DVT

    70 / 824
    140 / 878
    0,53 [0,41;0,70]

    major VTE (fatal and non fatal DVT,PE)

    9 / 908
    24 / 925
    0,38 [0,18;0,82]

    Deep vein thrombosis

    79 / 824
    160 / 878
    0,53 [0,41;0,68]
    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 0 / 1201 (0,0%) 6 / 1217 (0,5%) 0,08 [0,00;1,51]    
    non-fatal pulmonary embolism 0 / 824 (0,1%) 2 / 878 (0,2%) 0,27 [0,01;5,90]    
    proximal DVT 9 / 824 (1,1%) 20 / 878 (2,3%) 0,48 [0,22;1,05]    
    Major bleeding 7 / 1254 (0,6%) 6 / 1277 (0,5%) 1,19 [0,40;3,53]    
    Symptomatic venous thromboembolism (DVT, PE) 8 / 1201 (0,7%) 24 / 1217 (2,0%) 0,34 [0,15;0,75]    
    total VTE and all-cause mortality 79 / 824 (9,6%) 166 / 878 (18,9%) 0,51 [0,39;0,65]    
    distal DVT 70 / 824 (8,5%) 140 / 878 (15,9%) 0,53 [0,41;0,70]    
    major VTE (fatal and non fatal DVT,PE) 9 / 908 (1,0%) 24 / 925 (2,6%) 0,38 [0,18;0,82]    
    Deep vein thrombosis 79 / 824 (9,6%) 160 / 878 (18,2%) 0,53 [0,41;0,68]   7771 
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:
  • 7771: Lassen MR, Ageno W, Borris LC, Lieberman JR, Rosencher N, Bandel TJ, Misselwitz F, Turpie AGRivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty.N Engl J Med 2008 Jun 26;358:2776-86

  • Endpoint studied treat. control treat. mean diff

    Absolute risk reduction
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    proximal DVT 1,09% 2,28% -11,9‰
    Major bleeding 5,58‰ 4,70‰ 0,9‰
    Symptomatic venous thromboembolism (DVT, PE) 6,66‰ 1,97% -13,1‰
    total VTE and all-cause mortality 9,59% 18,91% -93,2‰
    distal DVT 8,50% 15,95% -74,5‰
    major VTE (fatal and non fatal DVT,PE) 9,91‰ 2,59% -16,0‰
    Deep vein thrombosis 9,59% 18,22% -86,4‰

    Meta-analysis of all similar trials:

    anticoagulant in DVT prophylaxis for orthopedic surgery

    antithrombotics in DVT prophylaxis for orthopedic surgery

    antithrombotics in DVT prophylaxis for elective major knee surgery

    direct factor Xa inhibitors in DVT prophylaxis for all type of patients

    new anticoagulants in DVT prophylaxis for all type of patients

    new anticoagulants in DVT prophylaxis for elective major knee surgery



    Reference(s)

    Trials register # NCT00361894
    Study web site link ,
    • Lassen MR, Ageno W, Borris LC, Lieberman JR, Rosencher N, Bandel TJ, Misselwitz F, Turpie AG. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty.. N Engl J Med 2008 Jun 26;358:2776-86
      Pubmed | Hubmed | Fulltext

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