Rapid Quantitative D-dimer to Exclude Pulmonary Embolism: A Prospective Cohort Management Study.
J Thromb Haemost. 2015 Dec 26;
Authors: Bates SM, Takach Lapner S, Douketis JD, Kearon C, Julian J, Parpia S, Schulman S, Weitz JI, Linkins LA, Crowther M, Lim W, Spencer FA, Lee AY, Gross PL, Ginsberg J
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 without further testing. Patients with D-dimer levels of 750 μg FEU/L or higher underwent standardized imaging tests for PE. All patients in whom PE was excluded had anticoagulant therapy withheld and were followed for three months for venous thromboembolism (VTE). Suspected events during follow-up were adjudicated centrally.
RESULTS: 808 patients were enrolled, among whom 99 (12%) were diagnosed with VTE at presentation. 420 (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% to 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. This article is protected by copyright. All rights reserved.
PMID: 26707364 [PubMed - as supplied by publisher]