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See also:

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

    RECORD 4 study, 2009

    [NCT00362232] Facebook    pdf : rivaroxaban - antithrombotics for DVT prophylaxis

    Treatments

    Studied treatment rivaroxaban 10mg once daily for 10 to 14 days
    starting six to eight hours postsurgery
    Control treatment enoxaparin 30 mg twice daily by subcutaneous injection for 10 to 14 days
    started 12 to 24 hours postsurgery
    Treatments description
    enoxaprin regimen started after surgery  
    treatment duration 10-14 days 

    Patients

    Patients patients who had undergone total-knee-replacement surgery
    Inclusion criteria aged 18 years or older and were scheduled for total knee arthroplasty
    Exclusion criteria active bleeding or a high risk of bleeding; any disorder contraindicating the use of enoxaparin or that might necessitate enoxaparin dose adjustment; disorders preventing bilateral venography; clinically signifi cant liver disease, severe renal impairment (creatinine clearance <30 mL per min); concomitant use of drugs that strongly inhibit cytochrome P450, such as protease inhibitors or ketoconazole; pregnancy; breastfeeding; planned intermittent pneumatic compression; requirement for ongoing anticoagulant therapy
    Baseline characteristics
    Age (mean), years 64.5 y 
    Total hip replacement 0% 
    Total knee replacement 100% 
    Weight, kg, 84.5 kg 
    Female 65% 
    general anesthesia 43% 

    Method and design

    Randomized effectives 1584 / 1564 (studied vs. control)
    Design Parallel groups
    Blinding double blind
    Follow-up duration 40 days
    Number of centre 131
    Geographic area 12 countries
    Hypothesis Non inferiority
    Primary endpoint total VTE events


    Results

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

    All cause death

    2 / 1526
         3 / 1508
         classic 0,66 [0,11;3,94]

    major or clinically relevant non-major bleeding

    46 / 1526
         34 / 1508
         classic 1,34 [0,86;2,07]

    asymptomatic DVT

    55 / 965
         76 / 959
         0,72 [0,51;1,01]

    non-fatal pulmonary embolism

    4 / 1526
         8 / 1508
         0,49 [0,15;1,64]

    proximal DVT

    3 / 965
         13 / 959
         0,23 [0,07;0,80]

    Major bleeding

    10 / 1526
         4 / 1508
         classic 2,47 [0,78;7,86]

    total VTE and all-cause mortality

    67 / 965
         97 / 959
         0,69 [0,51;0,92]

    Symptomatic deep-vein thrombosis

    6 / 965
         10 / 959
         0,60 [0,22;1,63]

    distal DVT

    52 / 965
         63 / 959
         0,82 [0,57;1,17]

    major VTE (fatal and non fatal DVT,PE)

    13 / 1122
         22 / 1112
         0,59 [0,30;1,16]

    Symptomatic venous thromboembolism (DVT, PE)

    11 / 1526
         18 / 1508
         0,60 [0,29;1,27]     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 46 / 1526 (3,0%) 34 / 1508 (2,3%) 1,34 [0,86;2,07]   10751 
    All cause death 2 / 1526 (0,1%) 3 / 1508 (0,2%) 0,66 [0,11;3,94]   10751 
    asymptomatic DVT 55 / 965 (5,7%) 76 / 959 (7,9%) 0,72 [0,51;1,01]   10751 
    non-fatal pulmonary embolism 4 / 1526 (0,3%) 8 / 1508 (0,5%) 0,49 [0,15;1,64]   10751 
    proximal DVT 3 / 965 (0,3%) 13 / 959 (1,4%) 0,23 [0,07;0,80]   10751 
    Major bleeding 10 / 1526 (0,7%) 4 / 1508 (0,3%) 2,47 [0,78;7,86]    
    Symptomatic venous thromboembolism (DVT, PE) 11 / 1526 (0,7%) 18 / 1508 (1,2%) 0,60 [0,29;1,27]   10751 
    total VTE and all-cause mortality 67 / 965 (6,9%) 97 / 959 (10,1%) 0,69 [0,51;0,92]   10751 
    Symptomatic deep-vein thrombosis 6 / 965 (0,6%) 10 / 959 (1,0%) 0,60 [0,22;1,63]   10751 
    distal DVT 52 / 965 (5,4%) 63 / 959 (6,6%) 0,82 [0,57;1,17]   10751 
    major VTE (fatal and non fatal DVT,PE) 13 / 1122 (1,2%) 22 / 1112 (2,0%) 0,59 [0,30;1,16]   10751 
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:
  • 10751: Turpie AG, Lassen MR, Davidson BL, Bauer KA, Gent M, Kwong LM, Cushner FD, Lotke PA, Berkowitz SD, Bandel TJ, Benson A, Misselwitz F, Fisher WDRivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty (RECORD4): a randomised trial.Lancet 2009;:

    • 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 3,01% 2,25% 7,6‰
    All cause death 1,31‰ 1,99‰ -0,7‰
    asymptomatic DVT 5,70% 7,92% -22,3‰
    non-fatal pulmonary embolism 2,62‰ 5,31‰ -2,7‰
    proximal DVT 3,11‰ 1,36% -10,4‰
    Major bleeding 6,55‰ 2,65‰ 3,9‰
    Symptomatic venous thromboembolism (DVT, PE) 7,21‰ 1,19% -4,7‰
    total VTE and all-cause mortality 6,94% 10,11% -31,7‰
    Symptomatic deep-vein thrombosis 6,22‰ 1,04% -4,2‰
    distal DVT 5,39% 6,57% -11,8‰
    major VTE (fatal and non fatal DVT,PE) 1,16% 1,98% -8,2‰

    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 # NCT00362232
    Study web site link ,
    • Turpie AG, Lassen MR, Davidson BL, Bauer KA, Gent M, Kwong LM, Cushner FD, Lotke PA, Berkowitz SD, Bandel TJ, Benson A, Misselwitz F, Fisher WD. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty (RECORD4): a randomised trial.. Lancet 2009;:
      Pubmed | Hubmed | Fulltext

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