title: VIDAS D-dimer in combination with clinical pre-test probability to rule out pulmonary embolism. A systematic review of management outcome studies.
abstract: 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.
authors.affiliation: Thrombosis Program, Division of Hematology, Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada.
authors.forename: Marc
authors.initials: M
authors.lastname: Carrier
authors.forename: Marc
authors.initials: M
authors.lastname: Righini
authors.forename: Reza Karami
authors.initials: RK
authors.lastname: Djurabi
authors.forename: Menno V
authors.initials: MV
authors.lastname: Huisman
authors.forename: Arnaud
authors.initials: A
authors.lastname: Perrier
authors.forename: Philip S
authors.initials: PS
authors.lastname: Wells
authors.forename: Marc
authors.initials: M
authors.lastname: Rodger
authors.forename: Walter A
authors.initials: WA
authors.lastname: Wuillemin
authors.forename: Grégoire
authors.initials: G
authors.lastname: Le Gal
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000627:therapeutic use; D015415:Biomarkers / Q000097:blood; D003937:Diagnosis, Differential; D005260:Female; D005338:Fibrin Fibrinogen Degradation Products / Q000032:analysis*; D005863:Gestalt Theory; D006305:Health Status Indicators; D006801:Humans; D008297:Male; D011237:Predictive Value of Tests; D011655:Pulmonary Embolism / Q000097:blood* / Q000175:diagnosis* / Q000188:drug therapy / Q000209:etiology; D018570:Risk Assessment; D012307:Risk Factors; D012680:Sensitivity and Specificity
chemical_list: D000925:Anticoagulants; D015415:Biomarkers; D005338:Fibrin Fibrinogen Degradation Products; C036309:fibrin fragment D