Low-molecular-weight heparin (enoxaparin) as prophylaxis against venous thromboembolism after total hip replacement

D Bergqvist, G Benoni, O Björgell, H Fredin, U Hedlundh, S Nicolas, P Nilsson, G Nylander
New England Journal of Medicine 1996 September 5, 335 (10): 696-700

BACKGROUND: The risk of venous thromboembolism in patients undergoing total hip replacement is known to be high. However, the optimal duration of prophylaxis with anticoagulant agents after this procedure is unknown. We sought to determine whether one month of anticoagulant therapy with the low-molecular-weight heparin enoxaparin is more effective than enoxaparin therapy given only during the hospitalization for surgery.

METHODS: Two hundred sixty-two patients undergoing total hip replacement received enoxaparin during their hospitalizations (average stay, 10 to 11 days). They were then randomly assigned to receive enoxaparin or placebo (131 patients each). Blinded outpatient therapy (or placebo) was continued long enough that the total treatment period, inpatient plus outpatient, was one month for each patient. Bilateral ascending phlebography was performed 19 to 23 days after discharge, with deep-vein thrombosis as the primary end point. Distal and proximal thrombosis, pulmonary embolism, and hemorrhage were also recorded, as were deaths.

RESULTS: Venography was adequate in 116 patients in the placebo group and 117 in the enoxaparin group. We observed 43 episodes of deep-vein thrombosis and 2 episodes of pulmonary embolism in the placebo group, but only 21 episodes of deep-vein thrombosis and no episodes of pulmonary embolism in the enoxaparin group (incidence of thromboembolism, 39 percent and 18 percent, respectively; P<0.001). The difference in the incidence of proximal deep-vein thrombosis was also significant (24 percent and 7 percent in the placebo and enoxaparin groups, respectively; P<0.001). Six enoxaparin groups, respectively; P<0.001). Six patients in the enoxaparin group and one patient in the placebo group had hematomas at their injection sites. No patients died or had major complications.

CONCLUSIONS: There were significantly fewer venous thromboembolic complications in patients undergoing elective hip replacement when prophylaxis with enoxaparin was given for a total of one month, rather than only during the hospitalization.

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