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The Use of a Rapid D-dimer Blood Test in the Diagnostic Work-up for Pulmonary Embolism: A Management Study

Journal: Thrombosis and Haemostasis
ISSN: 0340-6245
Issue: 1999: 82/6 (Dec) pp.1562-1783
Pages: 1588-1502
Ahead of Print: ###MANUSCRIPT_aheadofprint###

The Use of a Rapid D-dimer Blood Test in the Diagnostic Work-up for Pulmonary Embolism: A Management Study

Marco R. de Groot (1, 2) , Marinus van Marwijk Kooy (2) , Jos G. J. Pouwels (3) , Anneke H. Engelage (4) , Bart F. Kuipers (5) , Harry R. Büller (1)
From the (1) Department of Vascular Medicine, Academic Medical Centre, Amsterdam, and the (2) Departments of Internal Medicine, (3) Clinical Chemistry, (4) Nuclear Medicine and (5) Pulmonology, Sophia Hospital, Zwolle, The Netherlands

Summary

Background. D-dimer assays have a potential to rule out pulmonary embolism in case of a normal test result. We studied the clinical utility of incorporating the SimpliRED D-dimer test result and clinical probability in the routine diagnostic work-up of patients with suspected acute pulmonary embolism. Methods. In a prospective management study 245 consecutive patients, hospitalised as well as outpatients, were included. A SimpliRED D-dimer test and perfusion/(ventilation) scintigraphy were obtained in all patients, whereas clinical probability was determined in the subgroup of patients with a non-diagnostic scan and normal D-dimer result. A diagnostic algorithm determined the necessity for further testing and decisions about treatment. All patients were followed up for 3 months. Results. In 54 patients (22%) with a normal lung scan and 50 patients (21%) with a high probability lung scan, antithrombotic therapy was withheld or started respectively, irrespective of the D-dimer result. A non-diagnostic lung scan was found in 137 (56%) patients, of whom 70 patients had an abnormal D-dimer test, in whom further testing was ordered. Of the remaining 67 patients with a non-diagnostic lung scan and normal D-dimer test 8 patients had a high clinical probability, and the subsequent ultrasonography and pulmonary angiography yielded pulmonary emboli in 1 patient. In the remaining 66 patients, pulmonary embolism was considered to be absent and antithrombotic treatment was stopped/withheld. During follow-up of these patients only one patient experienced a possible venous thromboembolic event (failure rate 1,5% ; 95% CI 0-8%). The SimpliRED D-dimer was normal in 6 of 61 patients with proven pulmonary embolism (sensitivity 90% ; 95% CI 80-96%). Conclusion. Our findings suggest that it is safe to withhold anticoagulant therapy in those patients with a non-diagnostic lung scan, a normal SimpliRED D-dimer test result, and without a high clinical probability. This results in a substantial decreased need for ultrasonography and pulmonary angiography. The SimpliRED should not be used in isolation to exclude pulmonary embolism.