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Title: Fondaparinux Reduces Risk of Postoperative Venous Thromboembolism After Hip Surgery

URL: http://archinte.ama-assn.org/cgi/content/abstract/163/11/1337

Arch Intern Med 2003;163:1337-1342. "Duration of Prophylaxis Against Venous Thromboembolism With Fondaparinux After Hip Fracture Surgery"
06/19/2003 10:24:53 AM
By Emma Hitt, PhD

Extended prophylaxis with fondaparinux for 3 weeks after hip fracture surgery appears to reduce the risk of venous thromboembolism (VTE) and is well tolerated, according to the findings of a multi-centre, randomised trial. Previous studies have shown that treatment with the new selective factor Xa inhibitor fondaparinux, administered for up to 11 days in patients undergoing surgery for hip fracture, reduces the rate of VTE. However, the benefit of thromboprophylaxis with fondaparinux for up to 4 weeks after surgery has not been evaluated in these high-risk patients. Bengt I. Eriksson, MD, PhD, with the Orthopaedics Department, Sahlgrenska University Hospital/Östra, Göteborg, Sweden and colleagues conducted a trial of 656 patients undergoing hip fracture surgery. Patients were randomly assigned to receive prophylaxis with a once-daily subcutaneous injection of either 2.5 mg of fondaparinux sodium or placebo for 19 to 23 days. All patients had received fondaparinux for 6 to 8 days before being randomised. In 428 patients assessed with bilateral venography, documented symptomatic deep vein thrombosis, or pulmonary embolism, fondaparinux reduced the incidence of VTE compared with placebo from 35.0% (77/220) to 1.4% (3/208), during 3 weeks of administration after an initial 1-week prophylaxis with fondaparinux. This indicated a relative reduction in risk of 95.9% (95% confidence interval, 87.2%-99.7%; p < 0.001). Likewise, an additional 3 weeks of fondaparinux prophylaxis significantly reduced the incidence of proximal deep vein thrombosis by 94%, and the incidence of symptomatic VTE by 88.8% (fondaparinux versus placebo 0.3% and 2.7%, respectively; p = 0.02). There was a trend toward more major bleeding in the fondaparinux group compared to the placebo group (P = .06), but there was no difference in the incidence of clinically relevant bleeding (leading to death, reoperation, or critical organ bleeding) between the 2 groups, the researchers report. The study findings confirm that the very high risk of VTE associated with surgery for hip fracture persists longer than 11 days, Dr. Eriksson and colleagues conclude. The researchers note that the "very low absolute number of venous thromboembolic events observed in the fondaparinux group indicates that no particular subgroup at lower risk for VTE can be identified; thus, all patients with hip fracture surgery, and not only high-risk targeted patients, should benefit from this 1-month treatment with fondaparinux."

http://archinte.ama-assn.org/cgi/content/abstract/163/11/1337

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