Clinical Utility of a Rapid Whole-Blood D-Dimer Assay in Patients with Cancer Who Present with Suspected Acute Deep Venous Thrombosis
- Agnes Y.Y. Lee, MD, FRCP(C);
- Jim A. Julian, MMath;
- Mark N. Levine, MD, FRCP(C);
- Jeffrey I. Weitz, MD, FRCP(C);
- Clive Kearon, MB, PhD, FRCP(C);
- Philip S. Wells, MD, FRCP(C); and
- Jeffrey S. Ginsberg, MD, FRCP(C)
Abstract
Background: Although D-dimer assays have high negative predictive values for the diagnosis of deep venous thrombosis, their accuracy in patients with cancer is uncertain.
Objective: To compare the clinical utility of a whole-blood D-dimer assay for the diagnosis of deep venous thrombosis in patients with and those without cancer.
Design: Retrospective analysis of three prospective studies.
Setting: Two tertiary care hospitals.
Patients: 1068 consecutive outpatients with suspected deep venous thrombosis.
Measurements: All patients underwent D-dimer testing and assessment with a priori diagnostic strategies that incorporated impedance plethysmography, compression ultrasonography, or contrast venography. Patients in whom deep venous thrombosis was not diagnosed initially were followed for 3 months for the development of thrombosis. Results of D-dimer testing were assessed according to the final diagnosis based on objective testing and clinical follow-up. Cancer status was identified at presentation.
Results: The prevalence of deep venous thrombosis was 48.8% in 121 patients with cancer and 14.6% in 947 patients without cancer. Although the sensitivity of the D-dimer assay was similar in patients with and those without cancer (86.4% [95% CI, 75.0% to 94.0%] and 82.6% [CI, 75.2% to 88.5%], respectively), the specificity was significantly lower in patients with cancer (48.4% [CI, 35.5% to 61.4%] and 82.2% [CI, 79.4% to 84.8%]), as was the negative predictive value (78.9% [CI, 62.7% to 90.4%] and 96.5% [CI, 94.9% to 97.8%]). In contrast, the likelihood ratios of a negative test result (0.28 [CI, 0.14 to 0.56] and 0.21 [CI, 0.15 to 0.31]) did not differ significantly.
Conclusions: A negative D-dimer test result in patients with cancer does not reliably exclude deep venous thrombosis because the negative predictive value of the test is significantly lower in these patients than in patients without cancer.
Article and Author Information
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Acknowledgment: The authors thank Ms. Julie Anderson for assistance with the chart reviews and data collection.
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Grant Support: Dr. Lee is a recipient of a Research Fellowship from the Heart and Stroke Foundation of Canada. Dr. Kearon is a recipient of a Research Scholarship from the Heart and Stroke Foundation of Ontario. Dr. Wells is a recipient of a Research Scholarship from the Heart and Stroke Foundation of Canada. Drs. Weitz and Ginsberg are recipients of Career Investigator Awards from the Heart and Stroke Foundation of Ontario.
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Requests for Reprints: Agnes Y. Y. Lee, MD, FRCP(C), Hamilton Civic Hospitals Research Centre, 711 Concession Street, Hamilton, Ontario L8V 1C3, Canada; e-mail, alee{at}thrombosis.hhscr.org.
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Current Author Addresses: Drs. Lee, Kearon, and Weitz and Mr. Julian: Hamilton Civic Hospitals Research Centre, 711 Concession Street, Hamilton, Ontario L8V 1C3, Canada.
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Dr. Levine: Hamilton Regional Cancer Centre, 699 Concession Street, Hamilton, Ontario L8V 5C2, Canada.
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Dr. Wells: Ottawa Civic Hospital, Civic Parkdale Clinic, Room 467, 737 Parkdale Avenue, Ottawa, Ontario K1Y 1J8, Canada.
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Dr. Ginsberg: McMaster University Medical Centre, 1200 Main Street West, Room 3X28, Hamilton, Ontario L8N 3Z5, Canada.
- Copyright ©2004 by the American College of Physicians
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