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Rapid quantitative D-dimer to exclude pulmonary embolism: a prospective cohort management study.
J Thromb Haemost. 2016 Mar; 14(3):504-9.JT

Abstract

ESSENTIALS: It is not known if D-dimer testing alone can safely exclude pulmonary embolism (PE). We studied the safety of using a quantitative latex agglutination D-dimer to exclude PE in 808 patients. 52% of patients with suspected PE had a negative D-dimer test and were followed for 3 months. The negative predictive value of D-dimer testing alone was 99.8%, suggesting it may safely exclude PE.

BACKGROUND

Strategies are needed to exclude pulmonary embolism (PE) efficiently without the need for imaging tests. Although validated rules for clinical probability assessment can be combined with D-dimer testing to safely exclude PE, the rules can be complicated or partially subjective, which limits their use.

OBJECTIVES

To determine if PE can be safely excluded in patients with a negative D-dimer without incorporating clinical probability assessment.

PATIENTS/METHODS

We enrolled consecutive outpatients and inpatients with suspected PE from four tertiary care hospitals. All patients underwent D-dimer testing using the MDA D-dimer test, a quantitative latex agglutination assay. PE was excluded in patients with a D-dimer less than 750 μg FEU L(-1) without further testing.

PATIENTS

with D-dimer levels of 750 μg FEU L(-1) or higher underwent standardized imaging tests for PE. All patients in whom PE was excluded had anticoagulant therapy withheld and were followed for 3 months for venous thromboembolism (VTE). Suspected events during follow-up were adjudicated centrally.

RESULTS

Eight hundred and eight patients were enrolled, of whom 99 (12%) were diagnosed with VTE at presentation. Four hundred and twenty (52%) patients had a negative D-dimer level at presentation and were not treated with anticoagulants; of these, one had VTE during follow-up. The negative predictive value of D-dimer testing for PE was 99.8% (95% confidence interval, 98.7-99.9%).

CONCLUSIONS

A negative latex agglutination D-dimer assay is seen in about one-half of patients with suspected PE and reliably excludes PE as a stand-alone test.

Authors+Show Affiliations

Department of Medicine, McMaster University, Hamilton, ON, Canada. Thrombosis and Atherosclerosis Research Institute, McMaster University, Hamilton, ON, Canada.Department of Medicine, McMaster University, Hamilton, ON, Canada.Department of Medicine, McMaster University, Hamilton, ON, Canada. Thrombosis and Atherosclerosis Research Institute, McMaster University, Hamilton, ON, Canada.Department of Medicine, McMaster University, Hamilton, ON, Canada. Thrombosis and Atherosclerosis Research Institute, McMaster University, Hamilton, ON, Canada.Ontario Clinical Oncology Group, Juravinski Hospital, Hamilton, ON, Canada.Ontario Clinical Oncology Group, Juravinski Hospital, Hamilton, ON, Canada.Department of Medicine, McMaster University, Hamilton, ON, Canada. Thrombosis and Atherosclerosis Research Institute, McMaster University, Hamilton, ON, Canada.Department of Medicine, McMaster University, Hamilton, ON, Canada. Thrombosis and Atherosclerosis Research Institute, McMaster University, Hamilton, ON, Canada.Department of Medicine, McMaster University, Hamilton, ON, Canada. Thrombosis and Atherosclerosis Research Institute, McMaster University, Hamilton, ON, Canada.Department of Medicine, McMaster University, Hamilton, ON, Canada. Thrombosis and Atherosclerosis Research Institute, McMaster University, Hamilton, ON, Canada.Department of Medicine, McMaster University, Hamilton, ON, Canada. Thrombosis and Atherosclerosis Research Institute, McMaster University, Hamilton, ON, Canada.Department of Medicine, McMaster University, Hamilton, ON, Canada. Thrombosis and Atherosclerosis Research Institute, McMaster University, Hamilton, ON, Canada.Department of Medicine, University of British Columbia, Vancouver, Canada.Department of Medicine, McMaster University, Hamilton, ON, Canada. Thrombosis and Atherosclerosis Research Institute, McMaster University, Hamilton, ON, Canada.Department of Medicine, McMaster University, Hamilton, ON, Canada. Thrombosis and Atherosclerosis Research Institute, McMaster University, Hamilton, ON, Canada.

Pub Type(s)

Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

26707364

Citation

Bates, S M., et al. "Rapid Quantitative D-dimer to Exclude Pulmonary Embolism: a Prospective Cohort Management Study." Journal of Thrombosis and Haemostasis : JTH, vol. 14, no. 3, 2016, pp. 504-9.
Bates SM, Takach Lapner S, Douketis JD, et al. Rapid quantitative D-dimer to exclude pulmonary embolism: a prospective cohort management study. J Thromb Haemost. 2016;14(3):504-9.
Bates, S. M., Takach Lapner, S., Douketis, J. D., Kearon, C., Julian, J., Parpia, S., Schulman, S., Weitz, J. I., Linkins, L. A., Crowther, M., Lim, W., Spencer, F. A., Lee, A. Y., Gross, P. L., & Ginsberg, J. (2016). Rapid quantitative D-dimer to exclude pulmonary embolism: a prospective cohort management study. Journal of Thrombosis and Haemostasis : JTH, 14(3), 504-9. https://doi.org/10.1111/jth.13234
Bates SM, et al. Rapid Quantitative D-dimer to Exclude Pulmonary Embolism: a Prospective Cohort Management Study. J Thromb Haemost. 2016;14(3):504-9. PubMed PMID: 26707364.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Rapid quantitative D-dimer to exclude pulmonary embolism: a prospective cohort management study. AU - Bates,S M, AU - Takach Lapner,S, AU - Douketis,J D, AU - Kearon,C, AU - Julian,J, AU - Parpia,S, AU - Schulman,S, AU - Weitz,J I, AU - Linkins,L A, AU - Crowther,M, AU - Lim,W, AU - Spencer,F A, AU - Lee,A Y Y, AU - Gross,P L, AU - Ginsberg,J, Y1 - 2016/02/05/ PY - 2015/07/03/received PY - 2015/12/29/entrez PY - 2015/12/29/pubmed PY - 2016/12/15/medline KW - D-dimer KW - humans KW - probability KW - pulmonary embolism KW - sensitivity and specificity KW - venous thromboembolism SP - 504 EP - 9 JF - Journal of thrombosis and haemostasis : JTH JO - J Thromb Haemost VL - 14 IS - 3 N2 - UNLABELLED: ESSENTIALS: It is not known if D-dimer testing alone can safely exclude pulmonary embolism (PE). We studied the safety of using a quantitative latex agglutination D-dimer to exclude PE in 808 patients. 52% of patients with suspected PE had a negative D-dimer test and were followed for 3 months. The negative predictive value of D-dimer testing alone was 99.8%, suggesting it may safely exclude PE. BACKGROUND: Strategies are needed to exclude pulmonary embolism (PE) efficiently without the need for imaging tests. Although validated rules for clinical probability assessment can be combined with D-dimer testing to safely exclude PE, the rules can be complicated or partially subjective, which limits their use. OBJECTIVES: To determine if PE can be safely excluded in patients with a negative D-dimer without incorporating clinical probability assessment. PATIENTS/METHODS: We enrolled consecutive outpatients and inpatients with suspected PE from four tertiary care hospitals. All patients underwent D-dimer testing using the MDA D-dimer test, a quantitative latex agglutination assay. PE was excluded in patients with a D-dimer less than 750 μg FEU L(-1) without further testing. PATIENTS: with D-dimer levels of 750 μg FEU L(-1) or higher underwent standardized imaging tests for PE. All patients in whom PE was excluded had anticoagulant therapy withheld and were followed for 3 months for venous thromboembolism (VTE). Suspected events during follow-up were adjudicated centrally. RESULTS: Eight hundred and eight patients were enrolled, of whom 99 (12%) were diagnosed with VTE at presentation. Four hundred and twenty (52%) patients had a negative D-dimer level at presentation and were not treated with anticoagulants; of these, one had VTE during follow-up. The negative predictive value of D-dimer testing for PE was 99.8% (95% confidence interval, 98.7-99.9%). CONCLUSIONS: A negative latex agglutination D-dimer assay is seen in about one-half of patients with suspected PE and reliably excludes PE as a stand-alone test. SN - 1538-7836 UR - https://www.unboundmedicine.com/medline/citation/26707364/Rapid_quantitative_D_dimer_to_exclude_pulmonary_embolism:_a_prospective_cohort_management_study_ L2 - https://doi.org/10.1111/jth.13234 DB - PRIME DP - Unbound Medicine ER -