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document
Prevention of venous thromboembolism after knee arthroplasty . A randomized , double-blind trial comparing enoxaparin with warfarin . OBJECTIVE To compare the effectiveness and safety of fixed-dose enoxaparin and adjusted dose warfarin in preventing venous thromboembolism after knee arthroplasty . DESIGN A randomized , double-blind controlled trial . SETTING 8 university hospitals . PATIENTS 670 consecutive patients who had knee arthroplasty . INTERVENTION Patients were randomly assigned to receive enoxaparin ( 30 mg subcutaneously every 12 hours ) or adjusted-dose warfarin ( international normalized ratio , 2.0 to 3.0 ) . Both regimens were started after surgery . MEASUREMENTS The primary end point was the incidence of deep venous thrombosis in patients with adequate bilateral venograms ; the secondary end point was hemorrhage . RESULTS Among the 417 patients with adequate venograms , 109 of 211 warfarin recipients ( 51.7 % ) had deep venous thrombosis compared with 76 of 206 enoxaparin recipients ( 36.9 % ) ( P = 0.003 ) . The absolute risk difference was 14.8 % in favor of enoxaparin ( 95 % Cl , 5.3 % to 24.1 % ) Twenty-two warfarin recipients ( 10.4 % ) and 24 enoxaparin recipients ( 11.7 % ) had proximal venous thrombosis ( P > 0.2 ) . The absolute risk difference was 1.2 % in favor of warfarin ( Cl , -7.2 % to 4.8 % ) . The incidence of major bleeding was 1.8 % ( 6 of 334 patients ) in the warfarin group and 2.1 % ( 7 of 336 patients ) in the enoxaparin group ( P > 0.2 ) . The absolute risk difference was 0.3 % in favor of warfarin ( Cl , -2.4 % to 1.8 % ) . CONCLUSIONS A postoperative , fixed-dose enoxaparin regimen is more effective than adjusted-dose warfarin in preventing deep venous thrombosis after knee arthroplasty . No differences were seen in the incidence of proximal venous thrombosis or clinically overt hemorrhage .
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Intervention_Pharmacological
enoxaparin
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Intervention_Pharmacological
warfarin .
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Intervention_Pharmacological
fixed-dose enoxaparin
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Intervention_Pharmacological
adjusted dose warfarin
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Intervention_Pharmacological
enoxaparin ( 30 mg subcutaneously every 12 hours ) or adjusted-dose warfarin ( international normalized ratio , 2.0 to 3.0 )
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Intervention_Pharmacological
warfarin
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Intervention_Pharmacological
enoxaparin
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Intervention_Pharmacological
enoxaparin
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Intervention_Pharmacological
warfarin
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Intervention_Pharmacological
enoxaparin
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Intervention_Pharmacological
warfarin
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Intervention_Pharmacological
enoxaparin
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Intervention_Pharmacological
warfarin
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Outcome_Other
effectiveness and safety
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Outcome_Physical
incidence of deep venous thrombosis
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Outcome_Physical
hemorrhage .
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Outcome_Physical
deep venous thrombosis
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Outcome_Physical
absolute risk difference
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Outcome_Physical
absolute risk difference
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Outcome_Physical
major bleeding
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Outcome_Physical
absolute risk difference
86807
Participant_Condition
knee arthroplasty
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Participant_Condition
after knee arthroplasty
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Participant_Sample-size
670
86810
Participant_Condition
knee arthroplasty
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Participant_Condition
adequate bilateral venograms
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Participant_Sample-size
417
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Participant_Condition
adequate venograms
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Participant_Condition
after knee arthroplasty