Efficacy and safety of enoxaparin versus unfractionated heparin for prevention of deep venous thrombosis after elective knee arthroplasty. Enoxaparin Clinical Trial Group.
This study was a randomized, parallel-group, open-label clinical trial comparing the efficacy and safety of Enoxaparin, a low-molecular-weight heparin, and unfractionated heparin to prevent deep venous thrombosis after elective total knee arthroplasty. Four hundred fifty-three patients were randomized and received study medications. The primary efficacy evaluation was unilateral contrast venography done at the end of study or earlier if clinically indicated. The primary safety outcome was the incidence of bleeding episodes. Patients were assigned to 1 of 2 postoperative treatment groups: Enoxaparin 30 mg subcutaneous every 12 hours (228 patients), or unfractionated heparin 5000 units subcutaneous every 8 hours (225 patients). The incidence of proximal and distal deep venous thrombosis in the Enoxaparin group was 24.6% (56/228), and in the heparin group 34.2% (77/225). Three major hemorrhagic episodes were observed in each treatment group. Two cases of pulmonary embolism occurred in patients receiving heparin (1 fatal); no cases occurred in patients receiving Enoxaparin. This study showed that Enoxaparin administered postoperatively 30 mg every 12 hours is more effective and as safe as unfractionated heparin prophylaxis to prevent deep venous thrombosis in patients having elective total knee arthroplasty.
D000368:Aged; D000925:Anticoagulants / Q000627:therapeutic use*; D017984:Enoxaparin / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced; D006493:Heparin / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007720:Knee Prosthesis; D008297:Male; D013924:Thrombophlebitis / Q000517:prevention & control*
D000925:Anticoagulants; D017984:Enoxaparin; D006493:Heparin