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Previous Volume 329:1370-1376 November 4, 1993 Number 19 Next

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ABSTRACT

Background Deep-vein thrombosis is a potentially life-threatening complication of total hip or knee replacement. There are few data on the effectiveness and safety of warfarin as compared with low-molecular-weight heparin as prophylaxis against this problem.

Methods We therefore performed a randomized, double-blind trial in 1436 patients to evaluate the effectiveness and safety of low-molecular-weight heparin (given subcutaneously once daily) as compared with adjusted-dose warfarin to prevent venous thrombosis after hip or knee replacement. Treatment with the drugs was started postoperatively. The primary end point was deep-vein thrombosis as detected by contrast venography (performed a mean of 9.4 days after surgery in each group).

Results Among the 1207 patients with interpretable venograms, 231 of 617 patients (37.4 percent) in the warfarin group and 185 of 590 patients (31.4 percent) in the low-molecular-weight-heparin group had deep-vein thrombosis (P = 0.03). The reduction in risk with low-molecular-weight heparin as compared with warfarin was 16 percent, and the absolute difference in the incidence of venous thrombosis was 6 percent in favor of low-molecular-weight heparin (95 percent confidence interval, 0.8 to 11.4 percent). The incidence of major bleeding was 1.2 percent (9 of 721 patients) in the warfarin group and 2.8 percent (20 of 715 patients) in the low-molecular-weight-heparin group (P = 0.04), and the absolute difference was 1.5 percent in favor of warfarin (95 percent confidence interval, 0.1 to 3.0 percent).

Conclusions Our data demonstrate that the small reduction in the incidence of venous thrombosis with low-molecular-weight heparin, as compared with warfarin, was offset by an increase in bleeding complications. Although the use of low-molecular-weight heparin is simpler, because it is administered subcutaneously without the need for monitoring, it may be more costly than warfarin. Warfarin is inexpensive, but the overall cost of its use is increased by the need to monitor the intensity of anticoagulation. At this time it is unclear which of these approaches is the most cost effective.

Source Information

From the Clinical Trials Unit, Faculty of Medicine, University of Calgary, Calgary, Alta., Canada (R.H., G.R., G.P., K.A., G.H., R.B.); Chedoke-McMaster Hospitals, Hamilton, Ont., Canada (D.R., F.S., A.P.); Ohio State University, Columbus (W.E., T.M.); Northwestern University, Chicago (D.G.); and LDS Hospital, Salt Lake City (C.G.E.).

Address reprint requests to Dr. Hull at the Department of Medicine, University of Calgary, 3330 Hospital Dr. NW, Calgary, AB T2N 4N1, Canada.

Full Text of this Article

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Low-Molecular-Weight Heparin vs. Warfarin for Prophylaxis against Deep-Vein Thrombosis
Hirsh J., Lotke P. A., Ecker M. L., Hull R. D., Pineo G. F.
Extract | Full Text  
N Engl J Med 1994; 330:862-863, Mar 24, 1994. Correspondence

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