Determinants of ELISA D-dimer sensitivity for unstable angina pectoris as defined by coronary catheterization.

Unstable angina pectoris is associated with elevated D-dimer levels. However, the operating characteristics (sensitivity, specificity, positive and negative predictive value) of the D-dimer assay for the diagnosis of coronary artery disease (CAD) are unknown. Using a prospective, observational design, we collected blood from 54 patients with unstable angina pectoris at admission and assayed for ELISA D-dimer levels. The sensitivity, specificity, and negative and positive prediction values for angiographically determined coronary artery disease were calculated at multiple discriminate levels. All patients underwent coronary catheterization. A statistically significant correlation was noted between ELISA D-dimer levels and age, male sex, hypertension, use of beta-blocker, fibrinogen levels and catheterization findings. No correlation was noted between ELISA D-dimer levels and degree of the coronary artery disease. Best results were provided at a discriminate level of 270 ng/ml, with sensitivity 70%, negative predictive value 72%, and overall accuracy 67%. All discriminate levels, however, provided values too low for diagnosis. In conclusion, ELISA D-dimer assay is a non-sensitive, non-specific test for coronary artery disease as defined by coronary catheterization. However, the assay adds information regarding the severity of disease in patients presenting with acute coronary syndrome. Copyright 2004 Wiley-Liss, Inc.