title: The use of a rapid D-dimer blood test in the diagnostic work-up for pulmonary embolism: a management study.
abstract: 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%).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Vascular Medicine, Academic Medical Centre, Amsterdam, The Netherlands. m.r.degroot@amc.uva.nl
authors.forename: M R
authors.initials: MR
authors.lastname: de Groot
authors.forename: M
authors.initials: M
authors.lastname: van Marwijk Kooy
authors.forename: J G
authors.initials: JG
authors.lastname: Pouwels
authors.forename: A H
authors.initials: AH
authors.lastname: Engelage
authors.forename: B F
authors.initials: BF
authors.lastname: Kuipers
authors.forename: H R
authors.initials: HR
authors.lastname: Büller
mesh_terms: D000328:Adult; D000368:Aged; D001780:Blood Coagulation Tests; D005260:Female; D005338:Fibrin Fibrinogen Degradation Products / Q000032:analysis*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011237:Predictive Value of Tests; D011446:Prospective Studies; D011655:Pulmonary Embolism / Q000097:blood / Q000175:diagnosis* / Q000503:physiopathology
chemical_list: D005338:Fibrin Fibrinogen Degradation Products; C036309:fibrin fragment D