ENOXAPARIN Clinical Trial Group (2)

Enoxaparin vs. warfarin for the prevention of venous thromboembolism after primary total knee arthroplasty (2001)

Condition

Prophylaxis for VTE after unilateral total knee replacement

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Objective

To compare the efficacy and safety of fixed-dose enoxaparin with that of adjusted-dose warfarin in the prevention of VTE in patients undergoing total knee arthroplasty

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Trial design

Prospective, randomized, open-label study with parallel groups
Active treatment: enoxaparin 30 mg s.c. twice daily starting within 8 hours after surgery and continued for 4–14 days (n=173)
Control treatment: warfarin 7.5 mg within 8 hours after wound closure, followed by adjusted daily doses to maintain an INR of 2.0–3.0 for 4–14 days (n=176)

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Endpoints

Primary efficacy endpoint: DVT and PE during the postoperative period
Primary safety endpoints: major and minor bleeding

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Trial participants

349 consecutive patients (38–89 years of age) undergoing a primary unilateral total knee arthroplasty

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Results

Efficacy outcome: In the all-treated-patients population (n=349), 80 of the 176 patients assigned to warfarin (45.5%) and 44 of the 173 patients assigned to enoxaparin (25.4%) had episodes of VTE; the difference between both groups was significant. The enoxaparin-treated patients also had a significantly lower incidence of proximal DVT (1.7% vs. 11.4%). Distal DVT occurred in 23.7% in the enoxaparin group and in 33.5% of the warfarin group. One patient treated with warfarin developed PE, as compared with none patient given enoxaparin
Safety outcome: Major bleeding occurred in 4 patients (2.3%) assigned to warfarin and in 9 patients (5.2%) assigned to enoxaparin. The incidence of clinically important operative-site hemorrhage was 3.4% and 6.9%, respectively. Minor bleeding events occurred in 21.0% of the warfarin-treated patients, as compared with 28.3% of the patients given enoxaparin. The rate of overall bleeding complications was significantly lower in the warfarin group than in the enoxaparin group (23.3% vs. 33.5%)

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Summary

Efficacy: In patients undergoing total knee arthroplasty, fixed-dose enoxaparin significantly reduced the incidence of VTE compared with that associated with adjusted-dose warfarin
Safety: Patients treated with enoxaparin had a significantly higher rate of overall bleeding complications, but there was no significant difference between groups with regard to occurrence of major hemorrhage

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Reference

Fitzgerald RH Jr, Spiro TE, Trowbridge AA, Gardiner GA Jr, Whitsett TL, O’Connell MB, Ohar JA, Young TR, for the Enoxaparin Clinical Trial Group. Prevention of venous thromboembolic disease following primary total knee arthroplasty. A randomized, multicenter, open-label, parallel-group comparison of enoxaparin and warfarin. J Bone Joint Surg 2001;83-A:900-906

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Corresponding author

R.H. Fitzgerald Jr., MD, Department of Orthopedic Surgery, Silverstein Pavilion, Hospital of the University of Pennsylvania, 3400 Spruce Street, Second Floor, Philadelphia, PA 19104

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