Negative D-dimer Result To Exclude Recurrent Deep Venous Thrombosis: A Management Trial

7 December 2004 | Volume 141 Issue 11 | Pages 839-845

Background: All of the available diagnostic tests for deep venous thrombosis (DVT) have limitations for excluding acute recurrent DVT. Measurement of plasma D-dimer by using an automated quantitative assay may be useful as a rapid exclusion test in patients with suspected recurrent DVT.

Objective: To test the safety of withholding additional diagnostic testing and heparin treatment in patients who have a negative D-dimer result at presentation (using the automated quantitative assay STA-Liatest D-di), regardless of their symptoms.

Design: Prospective cohort study.

Setting: Academic medical center in the United States.

Patients: 300 consecutive patients with suspected recurrent DVT.

Intervention: Patients underwent D-dimer testing at presentation. In patients with negative D-dimer results, heparin therapy was withheld, and no further diagnostic testing for DVT was done as part of the initial evaluation. Patients with positive D-dimer results underwent compression ultrasonography.

Measurements: The primary outcome measure was a diagnosis of new symptomatic venous thromboembolism confirmed by diagnostic testing during the 3-month follow-up period.

Results: Of the 300 study patients, the D-dimer result was negative at presentation in 134 patients (45%; negative cohort) and positive at presentation in 166 patients. Of the 166 patients, compression ultrasonography documented new DVT in 54 patients. Compression ultrasonography findings were normal in 79 patients and were inconclusive in 33 patients. After 3 months of follow-up, 1 of 134 patients in the negative cohort had confirmed venous thromboembolism (0.75% [95% CI, 0.02% to 4.09%]). Venous thromboembolism on follow-up could not be definitively excluded in 5 patients with recurrent leg symptoms and in 1 patient who died. If these patients are considered to have venous thromboembolism, the incidence during the 3-month follow-up period would be 6.0% (CI, 2.6% to 11.4%) (8 of 134 patients).

Limitations: There is no accepted diagnostic reference standard for recurrent DVT. The precision of the estimate of the incidence of venous thromboembolism on follow-up and the generalizability to settings other than an academic health center should be evaluated.

Conclusions: Measurement of plasma D-dimer by using the automated quantitative assay STA-Liatest D-di seems to provide a simple method for excluding acute recurrent DVT in symptomatic patients.

Editors' Notes Context Acute recurrent deep venous thrombosis (DVT) is often difficult to differentiate from post-thrombotic syndrome, and each of the established diagnostic methods has limitations. A reliable test that excludes the diagnosis would be clinically useful. Contribution Patients with suspected recurrent DVT underwent D-dimer testing. Heparin was withheld or withdrawn in patients with negative results, and no additional testing was performed, regardless of symptoms. Three-month follow-up showed a low incidence (0.75% [95% CI, 0.02% to 4.09%]) of confirmed DVT in patients with a negative D-dimer result. Implications D-dimer testing may obviate the need to perform additional testing in up to two thirds of patients being evaluated for recurrent DVT. –The Editors

 

Author and Article Information

From University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma.

Acknowledgments: The authors thank Kevin Dahlin, Kyle Enfield, Janette Epperly, Jay Heath, Brenda Holliefield, Cindy Jones, Peggy Powell, and Penny Razo-Mosier for their assistance with this project.

Grant Support: By an Oklahoma Center for the Advancement of Science and Technology (OCAST) Health Research Grant (HR0-052) and in part by a National Institutes of Health, National Heart, Lung, and Blood Institute Research Career Training Award (K23) (HL04200-03). STA-Liatest D-dimer reagents were provided by Diagnostica Stago.

Potential Financial Conflicts of Interest:Grants received: S.W. Rathbun (Diagnostica Stago); Other: S.W. Rathbun (reagents for D-dimer were provided by Diagnostica Stago).

Requests for Single Reprints: Suman W. Rathbun, MD, Department of Medicine, WP 3120, University of Oklahoma Health Sciences Center, 920 Stanton L. Young Boulevard, Oklahoma City, OK 73104; e-mail, suman-rathbun{at}ouhsc.edu.

Current Author Addresses: Drs. Rathbun and Whitsett: Department of Medicine, WP 3120, University of Oklahoma Health Sciences Center, 920 Stanton L. Young Boulevard, Oklahoma City, OK 73104.

Dr. Raskob: University of Oklahoma Health Sciences Center, College of Public Health, 801 Northeast 13th Street, Room 139, Oklahoma City, OK 73104.

Author Contributions: Conception and design: S.W. Rathbun, T.L. Whitsett, G.E. Raskob.

Analysis and interpretation of the data: S.W. Rathbun, T.L. Whitsett, G.E. Raskob.

Drafting of the article: S.W. Rathbun, T.L. Whitsett, G.E. Raskob.

Critical revision of the article for important intellectual content: S.W. Rathbun, T.L. Whitsett, G.E. Raskob.

Final approval of the article: S.W. Rathbun, T.L. Whitsett, G.E. Raskob.

Provision of study materials or patients: S.W. Rathbun, T.L. Whitsett.

Statistical expertise: G.E. Raskob.

Obtaining of funding: S.W. Rathbun.

Administrative, technical, or logistic support: S.W. Rathbun.

Collection and assembly of data: S.W. Rathbun, T.L. Whitsett, G.E. Raskob.

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