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See also:

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

    RECORD 2 study, 2008

    [NCT00332020] Facebook    pdf : extended rivaroxaban - antithrombotics for DVT prophylaxis

    Treatments

    Studied treatment extended thromboprophylaxis with rivaroxaban 10mg once daily for 31-39 days
    started 6 to 8 hours after wound closure
    Control treatment short-term thromboprophylaxis with enoxaparin 40mg subcutaneous once daily for 10-14 days
    initiated 12 h before surgery and restarted 6–8 h after wound closure
    Treatments description
    enoxaprin regimen started before surgery 
    treatment duration 31-39 days 

    Patients

    Patients patients undergoing elective total hip replacement
    Inclusion criteria Male and female patients aged 18 years or above; patients scheduled for elective total hip replacement
    Exclusion criteria Planned, staged total bilateral hip replacement Active bleeding or high risk of bleeding contraindicating treatment with low molecular weight heparin; Contraindication listed in the labeling or conditions precluding patient treatment with enoxaparin; conditions prohibiting bilateral venography (e.g. amputation of one leg, allergy to contrast media)
    Baseline characteristics
    Age (mean), years 61.5 
    Total hip replacement 100% 
    Total knee replacement 0% 
    Weight, kg, 74.75 
    Female 53.65 
    general anesthesia 33.6% 

    Method and design

    Randomized effectives 1252 / 1257 (studied vs. control)
    Design Parallel groups
    Blinding double blind
    Follow-up duration 30-42 days
    Number of centre 123
    Geographic area 21 countries worldwide
    Primary endpoint DVT, PE , all cause death


    Results

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

    major or clinically relevant non-major bleeding

    121 / 1228
    101 / 1229
    1,20 [0,93;1,54]

    All cause death

    2 / 864
    6 / 869
    0,34 [0,07;1,66]

    non-fatal pulmonary embolism

    1 / 864
    4 / 869
    classic 0,25 [0,03;2,25]

    proximal DVT

    5 / 864
    44 / 869
    0,11 [0,05;0,29]

    Major bleeding

    1 / 1228
    1 / 1229
    classic 1,00 [0,06;15,98]

    Symptomatic venous thromboembolism (DVT, PE)

    3 / 1212
    15 / 1207
    0,20 [0,06;0,69]

    total VTE and all-cause mortality

    17 / 864
    81 / 869
    0,21 [0,13;0,35]

    distal DVT

    9 / 864
    27 / 869
    0,34 [0,16;0,71]

    major VTE (fatal and non fatal DVT,PE)

    6 / 961
    49 / 962
    0,12 [0,05;0,28]

    Deep vein thrombosis

    14 / 864
    71 / 869
    0,20 [0,11;0,35]
    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 121 / 1228 (9,9%) 101 / 1229 (8,2%) 1,20 [0,93;1,54]   7763 
    All cause death 2 / 864 (0,2%) 6 / 869 (0,7%) 0,34 [0,07;1,66]   7763 
    non-fatal pulmonary embolism 1 / 864 (0,1%) 4 / 869 (0,5%) 0,25 [0,03;2,25]    
    proximal DVT 5 / 864 (0,6%) 44 / 869 (5,1%) 0,11 [0,05;0,29]    
    Major bleeding 1 / 1228 (0,1%) 1 / 1229 (0,1%) 1,00 [0,06;15,98]    
    Symptomatic venous thromboembolism (DVT, PE) 3 / 1212 (0,2%) 15 / 1207 (1,2%) 0,20 [0,06;0,69]   7763 
    total VTE and all-cause mortality 17 / 864 (2,0%) 81 / 869 (9,3%) 0,21 [0,13;0,35]    
    distal DVT 9 / 864 (1,0%) 27 / 869 (3,1%) 0,34 [0,16;0,71]    
    major VTE (fatal and non fatal DVT,PE) 6 / 961 (0,6%) 49 / 962 (5,1%) 0,12 [0,05;0,28]    
    Deep vein thrombosis 14 / 864 (1,6%) 71 / 869 (8,2%) 0,20 [0,11;0,35]    
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:
  • 7763: Kakkar AK, Brenner B, Dahl OE, Eriksson BI, Mouret P, Muntz J, Soglian AG, Pap AF, Misselwitz F, Haas SExtended duration rivaroxaban versus short-term enoxaparin for the prevention of venous thromboembolism after total hip arthroplasty: a double-blind, randomised controlled trial.Lancet 2008 Jun 24;:

  • 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 9,85% 8,22% 1,6%
    All cause death 2,31‰ 6,90‰ -4,6‰
    non-fatal pulmonary embolism 1,16‰ 4,60‰ -3,4‰
    proximal DVT 5,79‰ 5,06% -44,8‰
    Major bleeding 0,81‰ 0,81‰ 0,0‰
    Symptomatic venous thromboembolism (DVT, PE) 2,48‰ 1,24% -10,0‰
    total VTE and all-cause mortality 1,97% 9,32% -73,5‰
    distal DVT 1,04% 3,11% -20,7‰
    major VTE (fatal and non fatal DVT,PE) 6,24‰ 5,09% -44,7‰
    Deep vein thrombosis 1,62% 8,17% -65,5‰

    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 # NCT00332020
    Study web site link ,
    • Kakkar AK, Brenner B, Dahl OE, Eriksson BI, Mouret P, Muntz J, Soglian AG, Pap AF, Misselwitz F, Haas S. Extended duration rivaroxaban versus short-term enoxaparin for the prevention of venous thromboembolism after total hip arthroplasty: a double-blind, randomised controlled trial.. Lancet 2008 Jun 24;:
      Pubmed | Hubmed | Fulltext

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