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VIDAS D-dimer in combination with clinical pre-test probability to rule out pulmonary embolism - A systematic review of management outcome studies

Journal: Thrombosis and Haemostasis
ISSN: 0340-6245
DOI: http://dx.doi.org/10.1160/TH-08-10-0689
Issue: 2009: 101/5 (May) pp. 795-990
Pages: 886-892

VIDAS D-dimer in combination with clinical pre-test probability to rule out pulmonary embolism - A systematic review of management outcome studies

Marc Carrier1,2; Marc Righini3; Reza Karami Djurabi4; Menno V. Huisman4; Arnaud Perrier5; Philip S. Wells1,2; Marc Rodger1,2; Walter A. Wuillemin6; Grégoire Le Gal1,7

1Thrombosis Program, Division of Hematology, Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada; 2Clinical Epidemiology Program, Ottawa Health Research Institute, Ottawa, Ontario, Canada; 3Division of Angiology and Hemostasis, Geneva University Hospital and Faculty of Medicine, Geneva, Switzerland; 4Section of Vascular Medicine, Department of General Internal Medicine – Endocrinology, Leiden University Medical Center, Leiden, the Netherlands; 5Division of General Internal Medicine, Geneva University Hospital and Faculty of Medicine, Geneva, Switzerland; 6Division of Haematology and Central Haematology Laboratory Kantonsspital, Lucerne, and University of Berne Switzerland; 7Department of Internal Medicine and Chest Diseases, EA3878, Brest University Hospital, Brest, France

Keywords

Diagnosis, Predictive Value of Tests, venous thromboembolism, D-dimer, management study

Summary

Clinical outcome studies have shown that it is safe to withhold anticoagulant therapy in patients with suspected pulmonary embolism (PE) who have a negative D-dimer result and a low pretest probability (PTP) either using a PTP model or clinical gestalt. It was the objective of the present study to assess the safety of the combination of a negative VIDAS© D-dimer result in combination with a non-high PTP using the Wells or Geneva models to exclude PE. A systematic literature search strategy was conducted using MEDLINE, EMBASE, the Cochrane Register of Controlled Trials and all EBM Reviews. Seven studies (6 prospective management studies and 1 randomised controlled trial) reporting failure rates at three months were included in the analysis. Non-high PTP was defined as “unlikely” using the Wells' model, or “low/intermediate” PTP using either the Geneva score, the Revised Geneva Score, or clinical gestalt. Two reviewers independently extracted data onto standardised forms. A total of 5,622 patients with low/intermediate or unlikely PTP were assessed using the VIDAS D-dimer. PE was ruled out by a negative D-dimer test in 2,248 (40%, 95% confidence intervals [CI] 38.7 to 41.3%) of them. The three-month thromboembolic risk in patients left untreated on the basis of a low/intermediate or unlikely PTP and a negative D-dimer test was 3/2,166 (0.14%, 95% CI 0.05 to 0.41%). In conclusion, the combination of a negative VIDAS D-dimer result and a non-high PTP effectively and safely excludes PE in an important proportion of outpatients with suspected PE.

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