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document
Postoperative fondaparinux versus postoperative enoxaparin for prevention of venous thromboembolism after elective hip-replacement surgery : a randomised double-blind trial . BACKGROUND Elective hip-replacement surgery carries significant risk of venous thromboembolism , despite use of thromboprophylaxis . We aimed to see whether the pentasaccharide fondaparinux , the first drug of a new class of synthetic antithrombotic agents , could reduce this risk to a greater extent than other available treatments . METHODS In a double-blind study , we randomly assigned 2275 consecutive patients aged 18 years or older who were undergoing elective hip-replacement surgery to receive postoperative subcutaneous injections of either 2.5 mg fondaparinux once daily or 30 mg enoxaparin twice daily . The primary efficacy outcome was venous thromboembolism to day 11 . The main safety outcomes were bleeding and death . Patients were followed up for 6 weeks . FINDINGS We assessed venous thromboembolism to day 11 in 1584 ( 70 % ) of 2275 patients . By day 11 , venous thromboembolisms were recorded in 48 ( 6 % ) of 787 patients on fondaparinux and in 66 ( 8 % ) of 797 patients on enoxaparin . The relative reduction in risk was 26.3 % ( 95 % CI -10.8 to 52.8 , p=0.099 ) . The two groups did not differ in the number of patients who died or in the number who had clinically relevant bleeding . INTERPRETATION In patients undergoing elective hip-replacement surgery , 2.5 mg fondaparinux once daily was not significantly more effective than 30 mg enoxaparin twice daily in reducing risk of venous thromboembolism . However , the lower risk recorded with fondaparinux than enoxaparin was clinically important , with no increase in clinically relevant bleeding .
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Intervention_Pharmacological
Postoperative fondaparinux
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Intervention_Pharmacological
postoperative enoxaparin
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Intervention_Pharmacological
thromboprophylaxis
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Intervention_Pharmacological
pentasaccharide fondaparinux
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Intervention_Pharmacological
synthetic antithrombotic agents
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Intervention_Pharmacological
fondaparinux
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Intervention_Pharmacological
enoxaparin
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Intervention_Pharmacological
fondaparinux
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Intervention_Pharmacological
enoxaparin
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Intervention_Pharmacological
fondaparinux
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Intervention_Pharmacological
enoxaparin
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Intervention_Pharmacological
fondaparinux
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Intervention_Pharmacological
enoxaparin
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Outcome_Physical
venous thromboembolism
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Outcome_Physical
venous thromboembolism
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Outcome_Physical
venous thromboembolism
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Outcome_Physical
bleeding
9329
Outcome_Mortality
death
9330
Outcome_Physical
venous thromboembolism
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Outcome_Physical
venous thromboembolisms
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Outcome_Other
risk
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Outcome_Mortality
patients who died
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Outcome_Physical
clinically relevant bleeding .
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Outcome_Physical
venous thromboembolism .
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Outcome_Physical
clinically relevant bleeding .
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Participant_Condition
venous thromboembolism after elective hip-replacement surgery
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Participant_Sample-size
2275 consecutive patients
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Participant_Age
18 years or older
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Participant_Condition
hip-replacement surgery