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Previous Volume 349:1227-1235 September 25, 2003 Number 13 Next

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ABSTRACT

Background Several diagnostic strategies using ultrasound imaging, measurement of D-dimer, and assessment of clinical probability of disease have proved safe in patients with suspected deep-vein thrombosis, but they have not been compared in randomized trials.

Methods Outpatients presenting with suspected lower-extremity deep-vein thrombosis were potentially eligible. Using a clinical model, physicians evaluated the patients and categorized them as likely or unlikely to have deep-vein thrombosis. The patients were then randomly assigned to undergo ultrasound imaging alone (control group) or to undergo D-dimer testing (D-dimer group) followed by ultrasound imaging unless the D-dimer test was negative and the patient was considered clinically unlikely to have deep-vein thrombosis, in which case ultrasound imaging was not performed.

Results Five hundred thirty patients were randomly assigned to the control group, and 566 to the D-dimer group. The overall prevalence of deep-vein thrombosis or pulmonary embolism was 15.7 percent. Among patients for whom deep-vein thrombosis had been ruled out by the initial diagnostic strategy, there were two confirmed venous thromboembolic events in the D-dimer group (0.4 percent; 95 percent confidence interval, 0.05 to 1.5 percent) and six events in the control group (1.4 percent; 95 percent confidence interval, 0.5 to 2.9 percent; P=0.16) during three months of follow-up. The use of D-dimer testing resulted in a significant reduction in the use of ultrasonography, from a mean of 1.34 tests per patient in the control group to 0.78 in the D-dimer group (P=0.008). Two hundred eighteen patients (39 percent) in the D-dimer group did not require ultrasound imaging.

Conclusions Deep-vein thrombosis can be ruled out in a patient who is judged clinically unlikely to have deep-vein thrombosis and who has a negative D-dimer test. Ultrasound testing can be safely omitted in such patients.

Source Information

From the Departments of Medicine, Radiology, and Emergency Medicine, Ottawa Hospital, University of Ottawa, Ottawa, Ont. (P.S.W., M.R., M.F., B.L.); Queen Elizabeth II Health Sciences Centre, Dalhousie University, Halifax, N.S. (D.R.A., G.K., M.M.); London Health Sciences Centre, University of Western Ontario, London, Ont. (J.D.); and Henderson Hospital, McMaster University, Hamilton, Ont. (C.K.) — all in Canada.

Address reprint requests to Dr. Wells at Ottawa Hospital Civic Campus, Suite F647, 1053 Carling Ave., Ottawa, ON K1Y 4E9, Canada, or at pwells{at}ohri.ca.

Full Text of this Article

Related Letters:

D-Dimer in Venous Thromboembolism
Stern S. D., Propp D. A., Kumar A. M., Vayssairat M., de Clari L., Wells P. S., Anderson D.
Extract | Full Text | PDF  
N Engl J Med 2004; 350:192-194, Jan 8, 2004. Correspondence

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