Thromb Haemost 1999; 82(06): 1588-1592
DOI: 10.1055/s-0037-1614883
Rapid Communication
Schattauer GmbH

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

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

Publication History

Received 16 March 1999

Accepted after revision 26 July 1999

Publication Date:
10 December 2017 (online)

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.

 
  • References

  • 1 Silverstein MD, Heit HA, Mohr DN, Petterson T, O’Fallon WM, Melton LJ. Trends in the incidence of deep vein thrombosis and pulmonary embolism. Arch Intern Med 1998; 158: 585-93.
  • 2 Anderson Jr FA, Wheeler HB, Goldberg RJ, Hosmer DW, Patwardhan NA, Jovanovic B, Forcier A, Dalen JE. A population-based perspective of the hospital incidence and case-fatality rates of deep vein thrombosis and pulmonary embolism: The Worcestor DVT study. Arch Intern Med 1991; 151: 933-8.
  • 3 Kuijer PMM, Turkstra F, van Beek EJR, ten Cate JW, B¸ller HR. A survey of the diagnostic and therapeutic management of patients with suspected pulmonary embolism in the Netherlands. Neth J Med 1997; 50: 261-6.
  • 4 Bounameaux H, de Mourloose P, Perrier A, Reber G. Plasma measurement of D-dimer as diagnostic aid in suspected venous thromboembolism: An overview. Thromb Haemost 1994; 71: 1-6.
  • 5 Ginsberg JS, Wells PS, Brill-Edwards P, Donovan D, Panju A, van Beek EJR, Patel A. Application of a novel and rapid whole blood assay for D-dimer in patients with clinically suspected pulmonary embolism. Thromb Haemost 1995; 73: 35-8.
  • 6 de Moerloose P, Desmarais S, Bounameaux H, Reber G, Perrier A, Dupuy G, Pittet JL. Contribution of a new, rapid, individual and quantitative automated D-dimer ELISA to exclude pulmonary embolism. Thromb Haemost 1996; 75: 11-3.
  • 7 Van Beek EJR, Schenk ED, Michel BC, van den Ende B, Brandjes DPM, Van der Heide YT, Bossuyt PMM, B¸ller HR. The role of plasma D-dimer concentration in the exclusion of pulmonary embolism. Br J Haemost 1996; 92: 725-32.
  • 8 Turkstra F, van Beek EJR, ten Cate JW, B¸ller HR. Reliable rapid blood test for the exclusion of venous thromboembolism in symptomatic outpatients. Thromb Haemost 1996; 76: 9-11.
  • 9 Ginsberg JS, Wells PS, Kearon C, Anderson D, Crowther M, Weitz JI, Bormanis J, Brill-Edwards P, Turpie AG, MacKinnon B, Gent M, Hirsh J. Sensitivity and specificity of a rapid whole blood assay for D-dimer in the diagnosis of pulmonary embolism. Ann Intern Med 1998; 129: 1006-11.
  • 10 John MA, Elms MJ, O’Reilly EJ, Rylatt DB, Bundesen PG, Hillyard CJ. The SimpliRED D-dimer test: a novel assay for the detection of crosslinked fibrin degradation products in whole blood. Thromb Res 1990; 58: 273-81.
  • 11 Worsley DF, Alevi A. Comprehensive analysis of the results of the PIOPED study. J Nucl Med 1995; 36: 2380-7.
  • 12 van Beek EJR, Reekers JA, Batchelor DA, Brandjes DPM, Büller HR. Feasibility, safety and clinical utility of angiography in patients with suspected pulmonary embolism. Eur Radiol 1996; 6: 415-9.
  • 13 Turkstra F, Kuijer PMM, van Beek EJR, Brandjes DPM, ten Cate JW, Büller HR. Diagnostic utility of ultrasonography of leg veins in patients suspected of having pulmonary embolism. Ann Int Med 1997; 126: 775-81.
  • 14 Lensing AWA, Hirsh J, Büller HR. Diagnosis of venous thrombosis. In: Coleman RW, Hirsh J, Marder VJ, Salzman EW. eds. Hemostasis and Thrombosis. Basic principles and clinical practice. Philadelphia: JB Lippinicot; 1994: 1297-321.
  • 15 Hull RD, Hirsh J, Carter CJ, Jay RM, Dodd PE, Ockelford PA, Coates G, Gill GJ, Turpie AG, Doyle DJ, Büller HR, Raskob GE. Pulmonary angiography, ventilation scanning, and venography for clinically suspected pulmonary embolism with abnormal perfusion lung scan. Ann Int Med 1983; 98: 891-9.
  • 16 PIOPED investigators. Value of the ventilation-perfusion scan in acute pulmonary embolism: results of the Prospective Investigation of Pulmonary Embolism Diagnosis (PIOPED). JAMA 1990; 263: 2753-9.
  • 17 Hull RD, Raskob GE, Coates G, Panju AA. Clinical Validity of a normal perfusion lung scan in patients with suspected pulmonary embolism. Chest 1990; 97: 23-6.
  • 18 Perrier A, Desmarais S, Miron MJ, de Moerloose P, Lepage R, Slosman D, Didier D, Unger PF, Patenaude JV, Bounameaux H. Non-invasive diagnosis of venous thromboembolism in outpatients. Lancet 1999; 253: 190-5.
  • 19 Freyburger G, Trillaud H, Labrouche S, Gauthier P, Javorschi S, Bernard P, Grenier N. D-dimer strategy in thrombosis exclusion. A gold standard study in 100 patients suspected of deep venous thrombosis or pulmonary embolism: 8 DD methods compared. Thromb Haemost 1998; 79: 32-7.
  • 20 Janssen MCH, Heebels AE, de Metz M, Verbruggen H, Wollersheim H, Janssen S, Schuurmans MMJ, Novakova IRO. Reliability of five rapid D-dimer assays compared to ELISA in the exclusion of deep venous thrombosis. Thromb Haemost 1997; 77: 262-6.
  • 21 DíAngelo A, DíAlessandro G, Tomassini L, Pittet JL, Dupuy G, Crippa L. Evaluation of a new rapid quantitative D-dimer assay in patients with clinically suspected deep vein thrombosis. Thromb Haemost 1996; 75: 412-6.
  • 22 Mauron T, Baumgartner I, ZíBrun A, Demarmels Biasutti F, Redondo M, Do DD, Lammle B, Wuillemin WA. SimpliRED D-dimer assay; Comparability of capillary and citrated venous whole blood, between assay variability, and performance of the test for exclusion of deep vein thrombosis in symptomatic outpatients. Thromb Haemost 1998; 79: 1217-9.
  • 23 Turkstra F, van Beek EJR, Büller HR. Observer and biological variation of a rapid whole D-dimer test. Thromb Haemost 1998; 79: 91-3.