Fondaparinux Compared with Enoxaparin for the Prevention of Venous Thromboembolism after Hip-Fracture Surgery
Bengt I. Eriksson, M.D., Kenneth A. Bauer, M.D., Michael R. Lassen, M.D., Alexander G.G. Turpie, F.R.C.P., for the Steering Committee of the Pentasaccharide in Hip-Fracture Surgery Study
Background Surgery for hip fracture carries a high risk of venousthromboembolism, despite the use of current thromboprophylactictreatments. Fondaparinux, a synthetic pentasaccharide, is anew antithrombotic agent that may reduce this risk.
Methods In a double-blind study, we randomly assigned 1711 consecutivepatients undergoing surgery for fracture of the upper thirdof the femur to receive subcutaneous doses of either 2.5 mgof fondaparinux once daily, initiated postoperatively, or 40mg of enoxaparin once daily, initiated preoperatively, for atleast five days. The primary efficacy outcome was venous thromboembolismup to postoperative day 11. Venous thromboembolism was definedas deep-vein thrombosis detected by mandatory bilateral venography,documented symptomatic deep-vein thrombosis, or documented symptomaticpulmonary embolism. The main safety outcomes were major bleedingand mortality from all causes. The duration of follow-up wassix weeks.
Results The incidence of venous thromboembolism by day 11 was8.3 percent (52 of 626 patients) in the fondaparinux group and19.1 percent (119 of 624 patients) in the enoxaparin group (P<0.001).The reduction in risk with fondaparinux was 56.4 percent (95percent confidence interval, 39.0 to 70.3 percent). There wereno significant differences between the two groups in the incidenceof death or clinically relevant bleeding.
Conclusions In patients undergoing surgery for hip fracture,fondaparinux was more effective than enoxaparin in preventingvenous thromboembolism and was equally safe.
Source Information
From the Department of Orthopedics, Sahlgrenska University HospitalÖstra, Göteborg, Sweden (B.I.E.); the Department of Medicine, Veterans Affairs Boston Healthcare System and Beth Israel Deaconess Medical Center, Boston (K.A.B.); the Department of Orthopedics, Hillerød University, Hillerød, Denmark (M.R.L.); and the Department of Medicine, Hamilton Health Sciences CorporationGeneral Division, Hamilton, Ont., Canada (A.G.G.T.).
Address reprint requests to Dr. Eriksson at the Orthopedics Department, Sahlgrenska University HospitalÖstra, S-41685 Göteborg, Sweden, or at b.eriksson{at}orthop.gu.se.
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