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See also:

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

    RECORD 1 study, 2008

    [NCT00329628] Facebook    pdf : extended rivaroxaban - antithrombotics for DVT prophylaxis

    Treatments

    Studied treatment rivaroxaban 10mg once daily for 35 days
    started 6 to 8 hours after wound closure
    Control treatment enoxaparin 40mg subcutaneous once daily
    initiated 12 hours before surgery and restarted 6 to 8 hours after wound closur
    Treatments description
    enoxaprin regimen started before surgery  
    treatment duration 31-39 days 

    Patients

    Patients patients undergoing total hip arthroplasty
    Inclusion criteria men and women of at least 18 years of age; scheduled to undergo elective total hip arthroplasty
    Exclusion criteria staged, bilateral hip arthroplasty; pregnant or breastfeeding; active bleeding or high risk of bleeding;contraindication for prophylaxis with enoxaparin or condition requiring an adjusted dose of enoxaparin; conditions preventing bilateral venography; substantial liver disease; severe renal impairment ; concomitant use of protease inhibitors for the treatment of human immunodeficiency virus infection; planned intermittent pneumatic compression; requirement for anticoagulant therapy that could not be stopped
    Baseline characteristics
    Age (mean), years 63.2y 
    Total hip replacement 100% 
    Total knee replacement 0% 
    Weight, kg, 78.2 
    Female 55.5 
    general anesthesia 39.7% 

    Method and design

    Randomized effectives 2209 / 2224 (studied vs. control)
    Design Parallel groups
    Blinding double blind
    Follow-up duration 36 days (range 30-42)
    Number of centre multicentre
    Geographic area 27 countries worldwide
    Hypothesis Non inferiority
    Primary endpoint DVT, PE, death


    Results

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

    All cause death

    4 / 1595
         4 / 1558
         classic 0,98 [0,24;3,90]

    non-fatal pulmonary embolism

    4 / 1595
         1 / 1558
         classic 3,91 [0,44;34,92]

    proximal DVT

    1 / 1595
         31 / 1558
         0,03 [0,00;0,23]

    Major bleeding

    6 / 2209
         2 / 2224
         classic 3,02 [0,61;14,95]

    Symptomatic venous thromboembolism (DVT, PE)

    6 / 2193
         11 / 2206
         0,55 [0,20;1,48]

    total VTE and all-cause mortality

    18 / 1595
         58 / 1558
         0,30 [0,18;0,51]

    distal DVT

    11 / 1595
         22 / 1558
         0,49 [0,24;1,00]

    major VTE (fatal and non fatal DVT,PE)

    4 / 1686
         33 / 1678
         0,12 [0,04;0,34]

    Deep vein thrombosis

    12 / 2209
         53 / 2224
         0,23 [0,12;0,43]     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 4 / 1595 (0,3%) 4 / 1558 (0,3%) 0,98 [0,24;3,90]   7772 
    non-fatal pulmonary embolism 4 / 1595 (0,3%) 1 / 1558 (0,1%) 3,91 [0,44;34,92]    
    proximal DVT 1 / 1595 (0,1%) 31 / 1558 (2,0%) 0,03 [0,00;0,23]    
    Major bleeding 6 / 2209 (0,3%) 2 / 2224 (0,1%) 3,02 [0,61;14,95]    
    Symptomatic venous thromboembolism (DVT, PE) 6 / 2193 (0,3%) 11 / 2206 (0,5%) 0,55 [0,20;1,48] during treatment  7772 
    total VTE and all-cause mortality 18 / 1595 (1,1%) 58 / 1558 (3,7%) 0,30 [0,18;0,51]    
    distal DVT 11 / 1595 (0,7%) 22 / 1558 (1,4%) 0,49 [0,24;1,00]    
    major VTE (fatal and non fatal DVT,PE) 4 / 1686 (0,2%) 33 / 1678 (2,0%) 0,12 [0,04;0,34]    
    Deep vein thrombosis 12 / 2209 (0,5%) 53 / 2224 (2,4%) 0,23 [0,12;0,43]    
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:
  • 7772: Eriksson BI, Borris LC, Friedman RJ, Haas S, Huisman MV, Kakkar AK, Bandel TJ, Beckmann H, Muehlhofer E, Misselwitz F, Geerts WRivaroxaban versus enoxaparin for thromboprophylaxis after hip arthroplastyN Engl J Med 2008;358:2765-75

    • Endpoint studied treat. control treat. mean diff

    Absolute risk reduction
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    All cause death 2,51‰ 2,57‰ -0,1‰
    non-fatal pulmonary embolism 2,51‰ 0,64‰ 1,9‰
    proximal DVT 0,63‰ 1,99% -19,3‰
    Major bleeding 2,72‰ 0,90‰ 1,8‰
    Symptomatic venous thromboembolism (DVT, PE) 2,74‰ 4,99‰ -2,3‰
    total VTE and all-cause mortality 1,13% 3,72% -25,9‰
    distal DVT 6,90‰ 1,41% -7,2‰
    major VTE (fatal and non fatal DVT,PE) 2,37‰ 1,97% -17,3‰
    Deep vein thrombosis 5,43‰ 2,38% -18,4‰

    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 hip replacement

    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 hip replacement



    Reference(s)

    Trials register # NCT00329628
    Study web site link ,
    • Eriksson BI, Borris LC, Friedman RJ, Haas S, Huisman MV, Kakkar AK, Bandel TJ, Beckmann H, Muehlhofer E, Misselwitz F, Geerts W. Rivaroxaban versus enoxaparin for thromboprophylaxis after hip arthroplasty. N Engl J Med 2008;358:2765-75 - 10.1056/NEJMoa0800374
      Pubmed | Hubmed | Fulltext

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