VIDAS D-dimer in combination with clinical pre-test probability to rule out pulmonary embolism

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.

[1]  T. Perneger,et al.  Diagnosis of pulmonary embolism by multidetector CT alone or combined with venous ultrasonography of the leg: a randomised non-inferiority trial , 2008, The Lancet.

[2]  J. Haukoos,et al.  Assessment of the pulmonary embolism rule-out criteria rule for evaluation of suspected pulmonary embolism in the emergency department. , 2008, The American journal of emergency medicine.

[3]  Patrick M Bossuyt,et al.  Further validation and simplification of the Wells clinical decision rule in pulmonary embolism , 2007, Thrombosis and Haemostasis.

[4]  D. Aujesky,et al.  Comparison of the revised Geneva score with the Wells rule for assessing clinical probability of pulmonary embolism , 2007, Journal of thrombosis and haemostasis : JTH.

[5]  G. Gal,et al.  Influence of age on the cost‐effectiveness of diagnostic strategies for suspected pulmonary embolism , 2007, Journal of thrombosis and haemostasis : JTH.

[6]  H R Büller,et al.  Diagnostic accuracy of D‐dimer test for exclusion of venous thromboembolism: a systematic review , 2007, Journal of thrombosis and haemostasis : JTH.

[7]  R. W. Niessen,et al.  Simple and safe exclusion of pulmonary embolism in outpatients using quantitative D-dimer and Wells’ simplified decision rule , 2006, Thrombosis and Haemostasis.

[8]  G. Simonneau,et al.  Diagnostic value of D-dimer in patients with suspected pulmonary embolism: results from a multicentre outcome study. , 2007, Thrombosis research.

[9]  M. Prins,et al.  A simple diagnostic strategy in hospitalized patients with clinically suspected pulmonary embolism , 2006, Journal of internal medicine.

[10]  G. Meyer,et al.  Clinical probability and alveolar dead space measurement for suspected pulmonary embolism in patients with an abnormal D‐dimer test result , 2006, Journal of thrombosis and haemostasis : JTH.

[11]  H. Büller,et al.  Accuracy of clinical decision rule, D‐dimer and spiral computed tomography in patients with malignancy, previous venous thromboembolism, COPD or heart failure and in older patients with suspected pulmonary embolism , 2006, Journal of thrombosis and haemostasis : JTH.

[12]  D. Aujesky,et al.  Clinical usefulness of D-dimer testing in cancer patients with suspected pulmonary embolism , 2006, Thrombosis and Haemostasis.

[13]  Arnaud Perrier,et al.  Prediction of Pulmonary Embolism in the Emergency Department: The Revised Geneva Score , 2006, Annals of Internal Medicine.

[14]  L. Moores.  Diagnosis and management of pulmonary embolism: are we moving toward an outcome standard? , 2006, Archives of internal medicine.

[15]  Pieter W Kamphuisen,et al.  Effectiveness of managing suspected pulmonary embolism using an algorithm combining clinical probability, D-dimer testing, and computed tomography. , 2006, JAMA.

[16]  P. Wells,et al.  Excluding pulmonary embolism at the bedside with low pre-test probability and D-dimer: safety and clinical utility of 4 methods to assign pre-test probability. , 2006, Thrombosis research.

[17]  R. W. Niessen,et al.  C‐reactive protein and D‐dimer with clinical probability score in the exclusion of pulmonary embolism , 2005, British journal of haematology.

[18]  G. Chatellier,et al.  Systematic review and meta-analysis of strategies for the diagnosis of suspected pulmonary embolism , 2005, BMJ : British Medical Journal.

[19]  M. Revel,et al.  Multidetector-row computed tomography in suspected pulmonary embolism. , 2005, The New England journal of medicine.

[20]  A. Didier,et al.  Diagnostic management of pulmonary embolism using clinical assessment, plasma D-dimer assay, complete lower limb venous ultrasound and helical computed tomography of pulmonary arteries , 2005, Thrombosis and Haemostasis.

[21]  H. Büller,et al.  Diagnostic strategy using a modified clinical decision rule and D-dimer test to rule out pulmonary embolism in elderly in- and outpatients , 2005, Thrombosis and Haemostasis.

[22]  J. Cornuz,et al.  Clinical usefulness of D-dimer depending on clinical probability and cutoff value in outpatients with suspected pulmonary embolism. , 2004, Archives of internal medicine.

[23]  Dorothy M Adcock,et al.  Prospective validation of Wells Criteria in the evaluation of patients with suspected pulmonary embolism. , 2004, Annals of emergency medicine.

[24]  J. Cornuz,et al.  Diagnosing pulmonary embolism in outpatients with clinical assessment, D-dimer measurement, venous ultrasound, and helical computed tomography: a multicenter management study. , 2004, The American journal of medicine.

[25]  P. Schnyder,et al.  Exclusion of pulmonary embolism using C-reactive protein and D-dimer. A prospective comparison. , 2003, Thrombosis and haemostasis.

[26]  D. Altman,et al.  Measuring inconsistency in meta-analyses , 2003, BMJ : British Medical Journal.

[27]  M. Prins,et al.  Diagnostic Strategies for Excluding Pulmonary Embolism in Clinical Outcome Studies , 2003, Annals of Internal Medicine.

[28]  B. Lämmle,et al.  Accuracy of d‐dimer/fibrinogen ratio to predict pulmonary embolism: a prospective diagnostic study , 2003, Journal of thrombosis and haemostasis : JTH.

[29]  H. Büller,et al.  The performance of two rapid quantitative D-dimer assays in 287 patients with clinically suspected pulmonary embolism. , 2002, Thrombosis research.

[30]  T. Perneger,et al.  Comparison of two clinical prediction rules and implicit assessment among patients with suspected pulmonary embolism. , 2002, The American journal of medicine.

[31]  H. Büller,et al.  Use of a clinical decision rule in combination with D-dimer concentration in diagnostic workup of patients with suspected pulmonary embolism: a prospective management study. , 2002, Archives of internal medicine.

[32]  S. Thompson,et al.  Quantifying heterogeneity in a meta‐analysis , 2002, Statistics in medicine.

[33]  D. Slosman,et al.  Performance of Helical Computed Tomography in Unselected Outpatients with Suspected Pulmonary Embolism , 2001, Annals of Internal Medicine.

[34]  B. Lämmle,et al.  Rapid D-dimer testing and pre-test clinical probability in the exclusion of deep venous thrombosis in symptomatic outpatients , 2001, Blood coagulation & fibrinolysis : an international journal in haemostasis and thrombosis.

[35]  T. Perneger,et al.  Assessing clinical probability of pulmonary embolism in the emergency ward: a simple score. , 2001, Archives of internal medicine.

[36]  M. Oudkerk,et al.  Rapid ELISA Assay for Plasma D-Dimer in the Diagnosis of Segmental and Subsegmental Pulmonary Embolism , 2000, Thrombosis and Haemostasis.

[37]  M Gent,et al.  Derivation of a Simple Clinical Model to Categorize Patients Probability of Pulmonary Embolism: Increasing the Models Utility with the SimpliRED D-dimer , 2000, Thrombosis and Haemostasis.

[38]  D. Slosman,et al.  Contribution of noninvasive evaluation to the diagnosis of pulmonary embolism in hospitalized patients , 1999 .

[39]  D. Slosman,et al.  Non-invasive diagnosis of venous thromboembolism in outpatients , 1999, The Lancet.

[40]  M Gent,et al.  Use of a Clinical Model for Safe Management of Patients with Suspected Pulmonary Embolism , 1998, Annals of Internal Medicine.

[41]  D. Slosman,et al.  D-dimer testing for suspected pulmonary embolism in outpatients. , 1997, American journal of respiratory and critical care medicine.

[42]  A. Laupacis,et al.  Clinical prediction rules. A review and suggested modifications of methodological standards. , 1997, JAMA.

[43]  R. J. Hayes,et al.  Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. , 1995, JAMA.