title: Whole blood gene expression testing for coronary artery disease in nondiabetic patients: major adverse cardiovascular events and interventions in the PREDICT trial.
abstract: The majority of first-time angiography patients are without obstructive coronary artery disease (CAD). A blood gene expression score (GES) for obstructive CAD likelihood was validated in the PREDICT study, but its relation to major adverse cardiovascular events (MACE) and revascularization was not assessed. Patients (N = 1,160) were followed up for MACE and revascularization 1 year post-index angiography and GES, with 1,116 completing follow-up. The 30-day event rate was 23% and a further 2.2% at 12 months. The GES was associated with MACE/revascularizations (p < 0.001) and added to clinical risk scores. Patients with GES >15 trended towards increased >30 days MACE/revascularization likelihood (odds ratio = 2.59, 95% confidence interval = 0.89-9.14, p = 0.082). MACE incidence overall was 1.5% (17 of 1,116) and 3 of 17 patients had GES ≤ 15. For the total low GES group (N = 396), negative predictive value was 90% for MACE/revascularization and >99% for MACE alone, identifying a group of patients without obstructive CAD and highly unlikely to suffer MACE within 12 months.
authors.affiliation: CardioDx, Inc, 2500 Faber Place, Palo Alto, CA 94303, USA. srosenberg@cardiodx.com
authors.forename: Steven
authors.initials: S
authors.lastname: Rosenberg
authors.forename: Michael R
authors.initials: MR
authors.lastname: Elashoff
authors.forename: Hsiao D
authors.initials: HD
authors.lastname: Lieu
authors.forename: Bradley O
authors.initials: BO
authors.lastname: Brown
authors.forename: William E
authors.initials: WE
authors.lastname: Kraus
authors.forename: Robert S
authors.initials: RS
authors.lastname: Schwartz
authors.forename: Szilard
authors.initials: S
authors.lastname: Voros
authors.forename: Stephen G
authors.initials: SG
authors.lastname: Ellis
authors.forename: Ron
authors.initials: R
authors.lastname: Waksman
authors.forename: John A
authors.initials: JA
authors.lastname: McPherson
authors.forename: Alexandra J
authors.initials: AJ
authors.lastname: Lansky
authors.forename: Eric J
authors.initials: EJ
authors.lastname: Topol
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015906:Angioplasty, Balloon, Coronary; D017023:Coronary Angiography; D001026:Coronary Artery Bypass; D003324:Coronary Artery Disease / Q000150:complications / Q000175:diagnosis* / Q000000981:diagnostic imaging / Q000235:genetics / Q000401:mortality / Q000628:therapy; D005260:Female; D005786:Gene Expression Regulation; D020022:Genetic Predisposition to Disease; D005820:Genetic Testing; D006801:Humans; D002546:Ischemic Attack, Transient / Q000209:etiology; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology; D016017:Odds Ratio; D010641:Phenotype; D011237:Predictive Value of Tests; D011379:Prognosis; D011446:Prospective Studies; D015203:Reproducibility of Results; D018570:Risk Assessment; D012307:Risk Factors; D020521:Stroke / Q000209:etiology; D013997:Time Factors; D014481:United States