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Roderik A. Kraaijenhagen, MD, PhD; Franco Piovella, MD, PhD; Enrico Bernardi, MD, PhD; Fabio Verlato, MD; Erik A. M. Beckers, MD; Maria M. W. Koopman, MD, PhD; Marisa Barone, MD; Giuseppe Camporese, MD; Bert Jan Potter van Loon, MD, PhD; Martin H. Prins, MD, PhD; Paolo Prandoni, MD, PhD; Harry R. Büller, MD, PhD

Arch Intern Med. 2002;162:907-911.

Background  The standard diagnostic approach in patients with suspected deep vein thrombosis is to repeat the compression ultrasonography after 1 week in all patients with an initial normal result. We hypothesized that a normal finding of a D-dimer assay safely obviates the need for repeated ultrasonography. In addition, we evaluated the potential value of a pretest probability assessment for this purpose.

Methods  At presentation, consecutive outpatients with suspected thrombosis underwent independent assessment by means of ultrasonography of the proximal veins, a whole-blood D-dimer assay, and a pretest clinical model. Patients with normal ultrasonographic findings and an abnormal D-dimer assay result were scheduled for repeated ultrasonography. We evaluated the incidence of symptomatic venous thromboembolic complications during a 3-month follow-up, and the value of clinical pretest probability with ultrasonography or D-dimer assay in scenario analyses.

Results  We studied 1756 patients with prevalence of thrombosis of 22%. At entry, results of the D-dimer assay and ultrasonography were normal in 828 patients (47%). Of these, 6 returned with confirmed symptomatic venous thromboembolism (complication rate, 0.7%; 95% confidence interval [CI], 0.3%-1.6%). Repeated ultrasonography was avoided in 61% of the patients with an initial normal test result. Scenario analyses disclosed that the complication rate was 1.6% (95% CI, 0.8%-2.6%) in those with a low clinical pretest probability and a normal result of ultrasonography at referral, whereas this figure was 1.8% (95% CI, 0.9%-3.3%) in patients with a low clinical probability result and a normal result of the D-dimer assay at referral.

Conclusions  It is safe to withhold repeated ultrasonography in patients with suspected deep vein thrombosis who have normal results of ultrasonograpy and the SimpliRED D-dimer assay at presentation. The combination of a low clinical pretest probability with a normal result of compression ultrasonography or the D-dimer assay appears to be equally safe in refuting the diagnosis of deep vein thrombosis.

From the Departments of Vascular Medicine (Drs Kraaijenhagen, Koopman, and Büller) and Clinical Epidemiology (Dr Prins), Academic Medical Center, University of Amsterdam, the Netherlands; the Thromboembolism Unit, IRCCS Policlinico San Matteo, Pavia, Italy (Drs Piovella and Barone); Clinica Medica II (Drs Bernardi and Prandoni) and Service of Angiology (Drs Verlato and Camporese), University Hospital of Padua, Padua, Italy; and the Department of Internal Medicine, Sint Lucas Andreas Hospital, Amsterdam, the Netherlands (Drs Beckers and Potter van Loon).

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