Abstract 14950: A Precision Medicine Blood Test Incorporating Age, Sex, and Gene Expression Showed Clinical Utility in the Evaluation of Outpatients Presenting With Stable Symptoms Suggestive of Obstructive Coronary Artery Disease - Final Endpoint Analysis From the PRESET Registry
Introduction: More effective tactics are needed to evaluate symptomatic patients with suspected obstructive coronary artery disease (CAD) in the outpatient setting, as current conventional methods overestimate disease prevalence. A blood-based age/sex/gene expression score (ASGES) incorporating key features of precision medicine has shown clinical validity with a 96% negative predictive value and 89% sensitivity in estimating a symptomatic patient’s current likelihood of obstructive CAD.
Objective: The objective of the community-based PRESET Registry was to evaluate the use of an age/sex/gene expression score (ASGES) and its effects on medical decision-making around referrals to cardiology or advanced cardiac testing.
Methods: -The prospective PRESET Registry (NCT01677156) enrolled stable, non-acute adult patients presenting with typical or atypical symptoms suggestive of obstructive CAD from 21 US primary care practices from August 2012 to August 2014. Demographics, clinical characteristics, and ASGES results (predefined as low [ASGES≤15] or elevated [ASGES>15]) were collected, as were referrals to cardiology or further functional/anatomic cardiac testing after ASGES testing. Patients were followed for 1-year post-ASGES testing.
Results: Among the 566 patient cohort (median age 56 years), clinicians referred 26/252 (10%) of patients with low scores versus 137/314 (44%) of patients with elevated scores to cardiology or advanced cardiac testing for further evaluation (unadjusted Odds Ratio (OR)=0.15, p<0.0001; adjusted OR after accounting for clinical covariates=0.18, p<0.0001). Major adverse cardiovascular events and revascularization were noted in 3/252 (1.2%) patients with low ASGES and 14/314 (4.5%) patients with elevated score ASGES (p<0.03).
Conclusion: In this community-based cardiovascular registry, the age/sex/gene expression score demonstrated clinical utility in the evaluation of patients with suspected obstructive CAD, thereby minimizing unnecessary cardiology referrals and additional cardiac testing of low-risk patients. Our work provides evidence supporting the value of using precision medicine in the delivery of cardiovascular care.
Author Disclosures: J. Ladapo: Consultant/Advisory Board; Modest; CardioDx. M. Budoff: Research Grant; Modest; CardioDx. D. Sharp: None. M. Zapien: Employment; Significant; CardioDx. Ownership Interest; Significant; CardioDx. L. Huang: Employment; Significant; CardioDx. Ownership Interest; Significant; CardioDx. B. Maniet: None. L. Herman: Research Grant; Modest; CardioDx. M. Monane: Employment; Significant; CardioDx. Ownership Interest; Significant; CardioDx.
- © 2016 by American Heart Association, Inc.