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Volume 337:1329-1335 November 6, 1997 Number 19 Next

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ABSTRACT

Background Patients who undergo total hip replacement have a high risk of thromboembolic complications. Recombinant hirudin (desirudin), a specific inhibitor of thrombin, represents a new development in antithrombotic therapy. We compared the efficacy and safety of desirudin with those of a low-molecular-weight heparin (enoxaparin) for the prevention of thromboembolic complications in patients undergoing primary total hip replacement.

Methods Both treatments, which were assigned in a randomized, double-blind manner, were started preoperatively: enoxaparin on the evening before surgery, and desirudin within 30 minutes before the start of surgery. The dose of desirudin was 15 mg subcutaneously twice daily, and the dose of enoxaparin was 40 mg subcutaneously once daily. The duration of treatment was 8 to 12 days. Deep-vein thrombosis was verified by bilateral venography performed at the end of the treatment period or earlier, if there were clinical signs of deep-vein thrombosis.

Results At 31 centers in 10 European countries, 2079 eligible patients were randomly assigned to receive desirudin or enoxaparin. A total of 1587 patients were included in the primary analysis of efficacy. In the desirudin group, as compared with the enoxaparin group, there was a significantly lower rate of proximal deep-vein thrombosis (4.5 vs. 7.5 percent, P = 0.01; relative reduction in risk, 40.3 percent) and a lower overall rate of deep-vein thrombosis (18.4 vs. 25.5 percent, P = 0.001; relative reduction in risk, 28.0 percent). The safety profiles were similar in the two treatment groups.

Conclusions When administered 30 minutes before total hip replacement, desirudin is more effective than enoxaparin in preventing deep-vein thrombosis.

Source Information

From the Departments of Orthopedics and Radiology, Sahlgrenska–Östra University Hospital, Göteborg, Sweden (B.I.E., P.K.); the Center for Clinical Thrombosis Research, Bispebjerg Hospital, Copenhagen, Denmark (P.W.-J.); Orthopädische Klinik der Städtischen Klinik, Goethe Universität, Frankfurt am Main, Germany (P.M.); the Département d'Anesthésie–Réanimation, Hôpital Cochin, Paris (N.R.); the Department of Orthopedic Surgery, Krankenhaus, Wiener Neustadt, Austria (P.B.); Novartis, Basel, Switzerland (M.B., S.E., D.B., P.C.); and Novartis, Stockholm, Sweden (S.L.).

Address reprint requests to Dr. Eriksson at the Department of Orthopedics, Sahlgrenska–Östra University Hospital, S-416 85 Göteborg, Sweden.

Full Text of this Article

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Recombinant Hirudin Compared with Low-Molecular-Weight Heparin to Prevent Thromboembolic Complications after Total Hip Replacement
Robb J., Eriksson B. I.
Extract | Full Text  
N Engl J Med 1998; 338:920-921, Mar 26, 1998. Correspondence

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