EFFICACY AND SAFETY OF ENOXAPARIN VERSUS UNFRACTIONATED HEPARIN FOR PREVENTION OF DEEP VENOUS THROMBOSIS AFTER ELECTIVE KNEE ARTHROPLASTY

This study was a randomized, parallel-group, open-label clinical trial comparing the efficacy and safety of Enoxaparin, a low-molecular-weig ht heparin, and unfractionated heparin to prevent deep venous thrombos is after elective total knee arthroplasty. Pour hundred fifty-three pa tients were randomized and received study medications. The primary eff icacy 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 subcuta neous every 8 hours (225 patients). The incidence of proximal and dist al deep venous thrombosis in the Enoxaparin group was 24.6% (56/228), and in the heparin group 34.2% (77/225). Three major hemorrhagic episo des were observed in each treatment group. Two cases of pulmonary embo lism occurred in patients receiving heparin (1 fatal); no cases occurr ed in patients receiving Enoxaparin. This study showed that Enoxaparin administered postoperatively 30 mg every 12 hours is more effective a nd as safe as unfractionated heparin prophylaxis to prevent deep venou s thrombosis in patients having elective total knee arthroplasty.