Evaluation of D-Dimer in the Diagnosis of Suspected Deep-Vein Thrombosis
Philip S. Wells, M.D., David R. Anderson, M.D., Marc Rodger, M.D., Melissa Forgie, M.D., Clive Kearon, M.D., Ph.D., Jonathan Dreyer, M.D., George Kovacs, M.D., Michael Mitchell, M.D., Bernard Lewandowski, M.D., and Michael J. Kovacs, M.D.
Background Several diagnostic strategies using ultrasound imaging,measurement of D-dimer, and assessment of clinical probabilityof disease have proved safe in patients with suspected deep-veinthrombosis, but they have not been compared in randomized trials.
Methods Outpatients presenting with suspected lower-extremitydeep-vein thrombosis were potentially eligible. Using a clinicalmodel, physicians evaluated the patients and categorized themas likely or unlikely to have deep-vein thrombosis. The patientswere 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 negativeand the patient was considered clinically unlikely to have deep-veinthrombosis, in which case ultrasound imaging was not performed.
Results Five hundred thirty patients were randomly assignedto the control group, and 566 to the D-dimer group. The overallprevalence of deep-vein thrombosis or pulmonary embolism was15.7 percent. Among patients for whom deep-vein thrombosis hadbeen ruled out by the initial diagnostic strategy, there weretwo 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 percentconfidence interval, 0.5 to 2.9 percent; P=0.16) during threemonths of follow-up. The use of D-dimer testing resulted ina significant reduction in the use of ultrasonography, froma mean of 1.34 tests per patient in the control group to 0.78in the D-dimer group (P=0.008). Two hundred eighteen patients(39 percent) in the D-dimer group did not require ultrasoundimaging.
Conclusions Deep-vein thrombosis can be ruled out in a patientwho is judged clinically unlikely to have deep-vein thrombosisand who has a negative D-dimer test. Ultrasound testing canbe 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.
Rodger, M. A. MD MSc, Kahn, S. R. MD MSc, Wells, P. S. MD MSc, Anderson, D. A. MD, Chagnon, I. MD, Le Gal, G. MD PhD, Solymoss, S. MD, Crowther, M. MD, Perrier, A. MD, White, R. MD, Vickars, L. MD, Ramsay, T. PhD MSc, Betancourt, M. T. MD MSc, Kovacs, M. J. MD
(2008). Identifying unprovoked thromboembolism patients at low risk for recurrence who can discontinue anticoagulant therapy. CMAJ
179: 417-426
[Abstract][Full Text]
Dewar, C, Corretge, M
(2008). Interrater reliability of the Wells score as part of the assessment of DVT in the emergency department: agreement between consultant and nurse practitioner. Emerg. Med. J.
25: 407-410
[Abstract][Full Text]
Dewar, C, Selby, C, Jamieson, K, Rogers, S
(2008). Emergency department nurse-based outpatient diagnosis of DVT using an evidence-based protocol. Emerg. Med. J.
25: 411-416
[Abstract][Full Text]
Ota, S., Wada, H., Abe, Y., Yamada, E., Sakaguchi, A., Nishioka, J., Hatada, T., Ishikura, K., Yamada, N., Sudo, A., Uchida, A., Nobori, T.
(2008). Elevated Levels of Prothrombin Fragment 1 + 2 Indicate High Risk of Thrombosis. CLIN APPL THROMB HEMOST
14: 279-285
[Abstract]
King, V., Vaze, A. A., Moskowitz, C. S., Smith, L. J., Ginsberg, M. S.
(2008). D-Dimer Assay to Exclude Pulmonary Embolism in High-Risk Oncologic Population: Correlation with CT Pulmonary Angiography in an Urgent Care Setting. Radiology
247: 854-861
[Abstract][Full Text]
Toll, D., Oudega, R, Vergouwe, Y, Moons, K., Hoes, A.
(2008). A new diagnostic rule for deep vein thrombosis: safety and efficiency in clinically relevant subgroups. Fam Pract
25: 3-8
[Abstract][Full Text]
Falanga, A., Lee, A. Y. Y., Streiff, M. B., Lyman, G. H.
(2008). Anticoagulation in the Treatment of Venous Thromboembolism in Patients with Cancer. Am Soc Clin Oncol Ed Book
2008: 258-268
[Abstract][Full Text]
Campbell, S., MacDonald, M., Carr, B., Anderson, D., MacKinley, R., Cairns, S.
(2008). Bridging the gap between primary and secondary care: use of a clinical pathway for the investigation and management of deep vein thrombosis. J Health Serv Res Policy
13: 15-19
[Abstract][Full Text]
Krivak, T. C., Zorn, K. K.
(2007). Venous Thromboembolism in Obstetrics and Gynecology. Obstet Gynecol
109: 761-777
[Abstract][Full Text]
Puls, M., Dellas, C., Lankeit, M., Olschewski, M., Binder, L., Geibel, A., Reiner, C., Schafer, K., Hasenfuss, G., Konstantinides, S.
(2007). Heart-type fatty acid-binding protein permits early risk stratification of pulmonary embolism. Eur Heart J
28: 224-229
[Abstract][Full Text]
Smellie, W S A, Forth, J, Ryder, S, Galloway, M J, Wood, A C, Watson, I D
(2006). Best practice in primary care pathology: review 5. J. Clin. Pathol.
59: 1229-1237
[Abstract][Full Text]
Scarvelis, D., Wells, P. S.
(2006). Diagnosis and treatment of deep-vein thrombosis.. CMAJ
175: 1087-1092
[Abstract][Full Text]
Sellier, E., Labarere, J., Bosson, J.-L., Auvray, M., Barrellier, M.-T., Le Hello, C., Belmin, J., Le Roux, P., Sevestre, M.-A., for the Association pour la Promotion de l'Angiolo,
(2006). Effectiveness of a guideline for venous thromboembolism prophylaxis in elderly post-acute care patients: a multicenter study with systematic ultrasonographic examination.. Arch Intern Med
166: 2065-2071
[Abstract][Full Text]
Aschbacher, K., von Kanel, R., Dimsdale, J. E., Patterson, T. L., Mills, P. J., Mausbach, B. T., Allison, M. A., Ancoli-Israel, S., Grant, I.
(2006). Dementia Severity of the Care Receiver Predicts Procoagulant Response in Alzheimer Caregivers. AJGP
14: 694-703
[Abstract][Full Text]
Goodacre, S., Stevenson, M., Wailoo, A., Sampson, F., Sutton, A.J., Thomas, S.
(2006). How should we diagnose suspected deep-vein thrombosis?. QJM
99: 377-388
[Abstract][Full Text]
Reilly, B. M., Evans, A. T.
(2006). Translating Clinical Research into Clinical Practice: Impact of Using Prediction Rules To Make Decisions. ANN INTERN MED
144: 201-209
[Abstract][Full Text]
Le Gal, G., Righini, M., Roy, P.-M., Sanchez, O., Aujesky, D., Perrier, A., Bounameaux, H.
(2006). Value of D-Dimer Testing for the Exclusion of Pulmonary Embolism in Patients With Previous Venous Thromboembolism. Arch Intern Med
166: 176-180
[Abstract][Full Text]
Wells, P. S., Owen, C., Doucette, S., Fergusson, D., Tran, H.
(2006). Does This Patient Have Deep Vein Thrombosis?. JAMA
295: 199-207
[Abstract][Full Text]
Subramaniam, R. M., Chou, T., Heath, R., Allen, R.
(2006). Importance of Pretest Probability Score and D-Dimer Assay Before Sonography for Lower Limb Deep Venous Thrombosis. Am. J. Roentgenol.
186: 206-212
[Abstract][Full Text]
Schneppenheim, R., Greiner, J.
(2006). Thrombosis in Infants and Children. ASH Education Book
2006: 86-96
[Abstract][Full Text]
Hlavac, M., Cook, J., Ojala, R., Town, I., Beckert, L.
(2005). Latex-Enhanced Immunoassay D-dimer and Blood Gases Can Exclude Pulmonary Embolism in Low-Risk Patients Presenting to an Acute Care Setting. Chest
128: 2183-2189
[Abstract][Full Text]
Subramaniam, R. M., Heath, R., Chou, T., Cox, K., Davis, G., Swarbrick, M.
(2005). Deep Venous Thrombosis: Withholding Anticoagulation Therapy after Negative Complete Lower Limb US Findings. Radiology
237: 348-352
[Abstract][Full Text]
Binder, L., Pieske, B., Olschewski, M., Geibel, A., Klostermann, B., Reiner, C., Konstantinides, S.
(2005). N-Terminal Pro-Brain Natriuretic Peptide or Troponin Testing Followed by Echocardiography for Risk Stratification of Acute Pulmonary Embolism. Circulation
112: 1573-1579
[Abstract][Full Text]
Oudega, R., Hoes, A. W., Moons, K. G.M.
(2005). The Wells Rule Does Not Adequately Rule Out Deep Venous Thrombosis in Primary Care Patients. ANN INTERN MED
143: 100-107
[Abstract][Full Text]
Goodacre, S., Sutton, A. J., Sampson, F. C.
(2005). Meta-Analysis: The Value of Clinical Assessment in the Diagnosis of Deep Venous Thrombosis. ANN INTERN MED
143: 129-139
[Abstract][Full Text]
Douketis, J. D.
(2005). Use of a Clinical Prediction Score in Patients with Suspected Deep Venous Thrombosis: Two Steps Forward, One Step Back?. ANN INTERN MED
143: 140-142
[Full Text]
Nelson, O. L.
(2005). Use of the D-dimer Assay for Diagnosing Thromboembolic Disease in the Dog. Journal of the American Animal Hospital Association
41: 145-149
[Abstract][Full Text]
Kearon, C., Ginsberg, J. S., Douketis, J., Crowther, M. A., Turpie, A. G., Bates, S. M., Lee, A., Brill-Edwards, P., Finch, T., Gent, M.
(2005). A Randomized Trial of Diagnostic Strategies after Normal Proximal Vein Ultrasonography for Suspected Deep Venous Thrombosis: D-Dimer Testing Compared with Repeated Ultrasonography. ANN INTERN MED
142: 490-496
[Abstract][Full Text]
Hull, R. D.
(2005). Revisiting the Past Strengthens the Present: An Evidence-Based Medicine Approach for the Diagnosis of Deep Venous Thrombosis. ANN INTERN MED
142: 583-585
[Full Text]
Siragusa, S., Anastasio, R., Porta, C., Falaschi, F., Pirrelli, S., Palmieri, P., Gamba, G., Granzow, K., Malato, A., Minardi, V., Tatoni, P., Bressan, M. A., Mariani, G.
(2004). Deferment of Objective Assessment of Deep Vein Thrombosis and Pulmonary Embolism Without Increased Risk of Thrombosis: A Practical Approach Based on the Pretest Clinical Model, D-Dimer Testing, and the Use of Low-Molecular-Weight Heparins. Arch Intern Med
164: 2477-2482
[Abstract][Full Text]
Rathbun, S. W., Whitsett, T. L., Raskob, G. E.
(2004). Negative D-dimer Result To Exclude Recurrent Deep Venous Thrombosis: A Management Trial. ANN INTERN MED
141: 839-845
[Abstract][Full Text]
Kosinski, C. M., Mull, M., Schwarz, M., Koch, B., Biniek, R., Schlafer, J., Milkereit, E., Willmes, K., Schiefer, J.
(2004). Do Normal D-dimer Levels Reliably Exclude Cerebral Sinus Thrombosis?. Stroke
35: 2820-2825
[Abstract][Full Text]
Perrier, A.
(2004). Review: several factors are associated with the performance of D-dimer assays for detecting deep venous thrombosis. Evid. Based Med.
9: 185-185
[Full Text]
Fancher, T. L, White, R. H, Kravitz, R. L
(2004). Combined use of rapid D-dimer testing and estimation of clinical probability in the diagnosis of deep vein thrombosis: systematic review. BMJ
329: 821-
[Abstract][Full Text]
McGuire, M., Dobesh, P. P.
(2004). Therapeutic Update on the Prevention and Treatment of Venous Thromboembolism. Journal of Pharmacy Practice
17: 289-307
[Abstract]
Philbrick, J. T., Heim, S., Schectman, J. M.
(2004). D-Dimer and Venous Thromboembolism. ANN INTERN MED
141: 482-482
[Full Text]
Le Gal, G., Righini, M., Bounameaux, H.
(2004). D-Dimer and Venous Thromboembolism. ANN INTERN MED
141: 481-482
[Full Text]
Blackshear, J. L.
(2004). Closure of patent foramen ovale in cryptogenic stroke: Ready or not, here come the trials. J Am Coll Cardiol
44: 759-761
[Full Text]
Heim, S. W., Schectman, J. M., Siadaty, M. S., Philbrick, J. T.
(2004). D-Dimer Testing for Deep Venous Thrombosis: A Metaanalysis. Clin. Chem.
50: 1136-1147
[Abstract][Full Text]
Stevens, S. M., Elliott, C. G., Chan, K. J., Egger, M. J., Ahmed, K. M.
(2004). Withholding Anticoagulation after a Negative Result on Duplex Ultrasonography for Suspected Symptomatic Deep Venous Thrombosis. ANN INTERN MED
140: 985-991
[Abstract][Full Text]
Segal, J. B
(2004). D-dimer testing reduced the need for ultrasonographic imaging in outpatients with suspected deep venous thrombosis. Evid. Based Med.
9: 89-89
[Full Text]
Perrier, A.
(2004). Labeling the Thrombus: The Future of Nuclear Medicine for Venous Thromboembolism?. Am. J. Respir. Crit. Care Med.
169: 977-978
[Full Text]
Stein, P. D., Hull, R. D., Patel, K. C., Olson, R. E., Ghali, W. A., Brant, R., Biel, R. K., Bharadia, V., Kalra, N. K.
(2004). D-Dimer for the Exclusion of Acute Venous Thrombosis and Pulmonary Embolism: A Systematic Review. ANN INTERN MED
140: 589-602
[Abstract][Full Text]
Zierler, B. K.
(2004). Ultrasonography and Diagnosis of Venous Thromboembolism. Circulation
109: I-9-I-14
[Abstract][Full Text]
Stern, S. D., Propp, D. A., Kumar, A. M., Vayssairat, M., de Clari, L., Wells, P. S., Anderson, D.
(2004). D-Dimer in Venous Thromboembolism. NEJM
350: 192-194
[Full Text]
(2003). Diagnosing DVT with D-dimer: Are We Ready Yet?. Journal Watch Cardiology
2003: 4-4
[Full Text]
(2003). D-dimer Testing Reduces Need for Ultrasound in Diagnosis of DVT. JWatch Emergency Med.
2003: 1-1
[Full Text]
(2003). D-dimer in the Diagnosis of DVT -- A Randomized Trial. JWatch General
2003: 1-1
[Full Text]
Fedullo, P. F., Tapson, V. F.
(2003). The Evaluation of Suspected Pulmonary Embolism. NEJM
349: 1247-1256
[Full Text]
Previous
