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See also:

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

    ADVANCE 2 (CV185-047) study, 2010

    [NCT00452530] Facebook    pdf : apixaban - antithrombotics for DVT prophylaxis

    Treatments

    Studied treatment apixaban 2.5mg twice daily during 12 days
    started 12�24 h after wound closure
    Control treatment enoxaparin 40mg once daily 12 days
    started 12 h before surgery
    Concomittant treatment test
    Remarks "European" enoxaprin regimen
    Treatments description
    enoxaprin regimen started before surgery  
    treatment duration 12 days 

    Patients

    Patients patients undergoing elective unilateral or bilateral total knee replacement
    Inclusion criteria scheduled to have unilateral elective total knee replacement or same-day bilateral knee replacement, including revision
    Exclusion criteria active bleeding or a contraindication to anticoagulant prophylaxis, or needed continuing anticoagulant or antiplatelet treatment; uncontrolled hypertension; active hepatobiliary disease; impaired renal function; thrombocytopenia, anaemia, heparin allergy; allergy to radiographic contrast dye; other disorders preventing bilateral venography
    Baseline characteristics
    Age (mean), years 67 y 
    Total hip replacement 0% 
    Total knee replacement 100% 
    Weight, kg, 78 kg 
    Female 72% 
    general anesthesia 35.5% 

    Method and design

    Randomized effectives 1528 / 1529 (studied vs. control)
    Design Parallel groups
    Blinding double blind
    Follow-up duration 12 days
    Lost to follow-up 35.5% (1084/3057)
    Number of centre 125
    Geographic area 27 countries
    Hypothesis Non inferiority
    Primary endpoint asymptomatic and symptomatic proximal DVT, PE, VTE-related death


    Results

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

    All cause death

    2 / 1528
         0 / 1529
         classic 9,01 [0,14;560,77]

    major or clinically relevant non-major bleeding

    53 / 1501
         72 / 1508
         0,74 [0,52;1,05]

    Symptomatic deep-vein thrombosis

    3 / 1528
         7 / 1529
         0,43 [0,11;1,66]

    major VTE (fatal and non fatal DVT,PE)

    13 / 1195
         26 / 1199
         0,50 [0,26;0,97]

    Deep vein thrombosis

    142 / 971
         243 / 997
         0,60 [0,50;0,72]

    total VTE and all-cause mortality

    147 / 976
         243 / 997
         0,62 [0,51;0,74]

    proximal DVT

    9 / 1192
         26 / 1199
         0,35 [0,16;0,74]

    Major bleeding

    9 / 1501
         14 / 1508
         0,65 [0,28;1,49]

    Symptomatic venous thromboembolism (DVT, PE)

    7 / 1528
         7 / 1529
         classic 1,00 [0,35;2,85]     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 53 / 1501 (3,5%) 72 / 1508 (4,8%) 0,74 [0,52;1,05]    
    All cause death 2 / 1528 (0,1%) 0 / 1529 (0,0%) 4,00 [0,18;88,69] During intended treatment  12099 
    proximal DVT 9 / 1192 (0,8%) 26 / 1199 (2,2%) 0,35 [0,16;0,74] symptomatic or asymptomatic  12099 
    Major bleeding 9 / 1501 (0,6%) 14 / 1508 (0,9%) 0,65 [0,28;1,49]   12099 
    Symptomatic venous thromboembolism (DVT, PE) 7 / 1528 (0,5%) 7 / 1529 (0,5%) 1,00 [0,35;2,85] or venous thromboembolism-related death  12099 
    total VTE and all-cause mortality 147 / 976 (15,1%) 243 / 997 (24,4%) 0,62 [0,51;0,74]    
    Symptomatic deep-vein thrombosis 3 / 1528 (0,2%) 7 / 1529 (0,5%) 0,43 [0,11;1,66] During intended treatment  12099 
    major VTE (fatal and non fatal DVT,PE) 13 / 1195 (1,1%) 26 / 1199 (2,2%) 0,50 [0,26;0,97] During intended treatment  12099 
    Deep vein thrombosis 142 / 971 (14,6%) 243 / 997 (24,4%) 0,60 [0,50;0,72] During intended treatment  12099 
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:
  • 12099: Lassen MR, Raskob GE, Gallus A, Pineo G, Chen D, Hornick PApixaban versus enoxaparin for thromboprophylaxis after knee replacement (ADVANCE-2): a randomised double-blind trial.Lancet 2010 Mar 6;375:807-15

    • 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 3,53% 4,77% -12,4‰
    proximal DVT 7,55‰ 2,17% -14,1‰
    Major bleeding 6,00‰ 9,28‰ -3,3‰
    Symptomatic venous thromboembolism (DVT, PE) 4,58‰ 4,58‰ 0,0‰
    total VTE and all-cause mortality 15,06% 24,37% -93,1‰
    Symptomatic deep-vein thrombosis 1,96‰ 4,58‰ -2,6‰
    major VTE (fatal and non fatal DVT,PE) 1,09% 2,17% -10,8‰
    Deep vein thrombosis 14,62% 24,37% -97,5‰

    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 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 # NCT00452530
    • Lassen MR, Raskob GE, Gallus A, Pineo G, Chen D, Hornick P. Apixaban versus enoxaparin for thromboprophylaxis after knee replacement (ADVANCE-2): a randomised double-blind trial.. Lancet 2010 Mar 6;375:807-15 - 10.1016/S0140-6736(09)62125-5
      Pubmed | Hubmed | Fulltext

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