PROMISE Substudy Results, Published in the American Heart Journal, Provide Independent Validation of the Clinical Value of the Corus(R) CAD Blood Test to Accurately Identify Patients with Obstructive CAD - Seite 2

The study, published in the American Heart Journal on February 2017, showed that patients with low Corus CAD test scores had a lower likelihood of obstructive CAD in the arteries, and the opposite is true for higher scores. The primary analysis found that the clinical event rate (defined as the composite rate of death, myocardial infarction (MI), hospitalization for unstable angina, or revascularization) was lower in patients with low Corus CAD test scores (1-15, n=1058 patients) as compared to patients with higher Corus CAD test scores ( >15, n=1312 patients) (odds ratio of 2.6, p< 0.001). 

Additionally, the clinical event rate for patients with low Corus CAD test scores (≤ 15) compared to noninvasive cardiac testing, was low and no different from a negative or normal cardiac stress test or CT-angiography (3.2% vs. 2.6%, p=0.29) at 25-month median follow-up.

The study included 2,370 non-diabetic patients from the PROMISE trial biobank repository and nearly half of the patients in the substudy were randomized to the coronary CT-angiography (CTA) arm (n=1,137). In this group, 10.1% of patients (n=115 of 1,137) were found to have obstructive CAD, and a Corus CAD score > 15 was associated with an increased likelihood of obstructive CAD (OR 2.5, p< 0.001).

Finally, the relationship between Corus CAD test scores and clinical event rates remained significant even after adjusting for common clinical risk factors using the Framingham Risk Score (FRS). When the Corus CAD test was added to functional (stress testing) or anatomical (CTA) testing, the Corus CAD test score provided independent and incremental information beyond that of noninvasive diagnostic imaging and helped to accurately reclassify patients to their appropriate risk levels. The increased risk of clinical events seen with elevated Corus CAD test scores were largely driven by a higher rate of revascularization procedures in this group, thus reaffirming that the likelihood of obstructive CAD (defined as >70% stenosis by CTA) increased with higher Corus CAD test scores.

"The results from the PROMISE substudy represent an opportunity to learn more about the integration of the test into clinical practice to help direct heart evaluations and care of patients with chest pain," said Pamela Douglas, Principal Investigator of the PROMISE study, Professor of Medicine, Ursula Geller Professor for Research in Cardiovascular Disease, Duke University Medical Center and member, Duke Clinical Research Institute.