Key result
Peripheral blood gene expression score maintains a stable 0.70 AUC for obstructive CAD across diverse cohorts.
Why the study?
The biological and analytical stability of a peripheral blood gene expression score for obstructive CAD required validation in multicenter cohorts.
Is a peripheral blood gene expression score for obstructive CAD analytically and biologically stable over time?
Observational (n=1,502)
Yes
Is a peripheral blood gene expression score for obstructive CAD analytically and biologically stable over time?
The peripheral blood gene expression score for obstructive CAD demonstrates robust analytic stability over 5 years and biological stability over 1 year, supporting its reliable clinical use.
Supports noninvasive CAD testing stability across ethnicities; leaves open whether it alters management or outcomes.
A gene expression score (GES) for obstructive coronary artery disease (CAD) has been validated in two multicenter studies. Receiver-operating characteristics (ROC) analysis of the GES on an expanded Personalized Risk Evaluation and Diagnosis in the Coronary Tree (PREDICT) cohort (NCT no. 00500617) with CAD defined by quantitative coronary angiography (QCA) or clinical reads yielded similar performance (area under the curve (AUC)=0.70, N=1,502) to the original validation cohort (AUC=0.70, N=526). Analysis of 138 non-Caucasian and 1,364 Caucasian patients showed very similar performance (AUCs=0.72 vs. 0.70). To assess analytic stability, stored samples of the original validation cohort (N=526) was re-tested after 5 years, and the mean score changed from 20.3 to 19.8 after 5 years (N=501, 95 %). To assess patient scores over time, GES was determined on samples from 173 Coronary Obstruction Detection by Molecular Personalized Gene Expression (COMPASS) study (NCT no. 01117506) patients at approximately 1 year post-enrollment. Mean scores increased slightly from 15.9 to 17.3, corresponding to a 2.5 % increase in obstructive CAD likelihood. Changes in cardiovascular medications did not show a significant change in GES.
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Daniels et al. (2014) conducted an observational in Obstructive coronary artery disease (n=1,502). Peripheral blood gene expression score (GES) vs. Original validation cohort / Baseline measurement was evaluated on Diagnostic accuracy (Area Under the Curve) for obstructive CAD (AUC 0.70, p=<0.001). The peripheral blood gene expression score maintained a stable diagnostic accuracy for obstructive coronary artery disease (AUC 0.70) across expanded cohorts and ethnicities, with minimal score variation over 1 to 5 years.
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