Low-Molecular-Weight Heparin (Enoxaparin) as Prophylaxis against Venous Thromboembolism after Total Hip Replacement
David Bergqvist, Ph.D., Göran Benoni, M.D., Ola Björgell, M.D., Hans Fredin, Ph.D., Urban Hedlundh, M.D., Sylvain Nicolas, Ph.D., Paul Nilsson, Ph.D., and Göran Nylander, Ph.D.
Background The risk of venous thromboembolism in patients undergoingtotal hip replacement is known to be high. However, the optimalduration of prophylaxis with anticoagulant agents after thisprocedure is unknown. We sought to determine whether one monthof anticoagulant therapy with the low-molecular-weight heparinenoxaparin is more effective than enoxaparin therapy given onlyduring the hospitalization for surgery.
Methods Two hundred sixty-two patients undergoing total hipreplacement received enoxaparin during their hospitalizations(average stay, 10 to 11 days). They were then randomly assignedto receive enoxaparin or placebo (131 patients each). Blindedoutpatient therapy (or placebo) was continued long enough thatthe total treatment period, inpatient plus outpatient, was onemonth for each patient. Bilateral ascending phlebography wasperformed 19 to 23 days after discharge, with deep-vein thrombosisas the primary end point. Distal and proximal thrombosis, pulmonaryembolism, and hemorrhage were also recorded, as were deaths.
Results Venography was adequate in 116 patients in the placebogroup and 117 in the enoxaparin group. We observed 43 episodesof deep-vein thrombosis and 2 episodes of pulmonary embolismin the placebo group, but only 21 episodes of deep-vein thrombosisand 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-veinthrombosis was also significant (24 percent and 7 percent inthe placebo and enoxaparin groups, respectively; P<0.001).Six patients in the enoxaparin group and one patient in theplacebo group had hematomas at their injection sites. No patientsdied or had major complications.
Conclusions There were significantly fewer venous thromboemboliccomplications in patients undergoing elective hip replacementwhen prophylaxis with enoxaparin was given for a total of onemonth, rather than only during the hospitalization.
Source Information
From the Department of Surgery, Academic Hospital, Uppsala, Sweden (D.B.); the Departments of Orthopedic Surgery (G.B., H.F., U.H.) and Diagnostic Radiology (O.B., P.N., G.N.), Malmö University Hospital, Malmö, Sweden; and the Department of Research and Development, RhônePoulenc Rorer, Paris (S.N.).
Address reprint requests to Dr. Bergqvist at Academic Hospital, Department of Surgery, S-751 85 Uppsala, Sweden.
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