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Previous Volume 349:146-153 July 10, 2003 Number 2 Next

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ABSTRACT

Background Patients with cancer have a substantial risk of recurrent thrombosis despite the use of oral anticoagulant therapy. We compared the efficacy of a low-molecular-weight heparin with that of an oral anticoagulant agent in preventing recurrent thrombosis in patients with cancer.

Methods Patients with cancer who had acute, symptomatic proximal deep-vein thrombosis, pulmonary embolism, or both were randomly assigned to receive low-molecular-weight heparin (dalteparin) at a dose of 200 IU per kilogram of body weight subcutaneously once daily for five to seven days and a coumarin derivative for six months (target international normalized ratio, 2.5) or dalteparin alone for six months (200 IU per kilogram once daily for one month, followed by a daily dose of approximately 150 IU per kilogram for five months).

Results During the six-month study period, 27 of 336 patients in the dalteparin group had recurrent venous thromboembolism, as compared with 53 of 336 patients in the oral-anticoagulant group (hazard ratio, 0.48; P=0.002). The probability of recurrent thromboembolism at six months was 17 percent in the oral-anticoagulant group and 9 percent in the dalteparin group. No significant difference between the dalteparin group and the oral-anticoagulant group was detected in the rate of major bleeding (6 percent and 4 percent, respectively) or any bleeding (14 percent and 19 percent, respectively). The mortality rate at six months was 39 percent in the dalteparin group and 41 percent in the oral-anticoagulant group.

Conclusions In patients with cancer and acute venous thromboembolism, dalteparin was more effective than an oral anticoagulant in reducing the risk of recurrent thromboembolism without increasing the risk of bleeding.

Source Information

From the Departments of Medicine (A.Y.Y.L., M.N.L.) and Clinical Epidemiology and Biostatistics (M.N.L., J.A.J., S.H., M.G.), McMaster University, Hamilton, Ont., Canada; Henderson Research Centre, Hamilton Health Sciences and McMaster University, Hamilton, Ont., Canada (M.N.L., J.A.J., S.H., M.G.); the Department of Medicine, University of Western Australia, Perth, Australia (R.I.B.); Pharmacia Corporation, Peapack, N.J. (C.B.); the Department of Surgical Oncology and Technology, Imperial College, London (A.K.K.); Academic Hospital Maastricht, Maastricht, the Netherlands (M.P.); the Department of Medicine and Pediatrics, George Washington University, Washington, D.C. (F.R.R.); and the Department of Medicine, University of Western Ontario, London, Ont., Canada (M.J.K.).

Address reprint requests to Dr. Levine at Hamilton Health Sciences, Henderson Hospital, Rm. 9, 90 Wing, 711 Concession St., Hamilton, ON L8V 1C3, Canada.

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Dalteparin Compared with an Oral Anticoagulant for Thromboprophylaxis in Patients with Cancer
Blot E., Gutman F., Thannberger A., Hull J. H.K., Hull P. J., Kaufman J. L., Nader F., Lee A. Y.Y., Levine M. N., Gent M., Bick R. L.
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N Engl J Med 2003; 349:1385-1387, Oct 2, 2003. Correspondence

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