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WOMEN

Aggregate Analysis of the Two Studies of Clinical Utility in Women

Purpose:

To observe if the age/sex/gene expression test (Corus CAD test) results are incorporated into medical decision making to help identify women whose symptoms are not due to obstructive CAD.

Type:

Review of aggregated data of two prospective studies

Size:

Data were pooled from 16 primary care providers (PCPs) in geographically diverse U.S. sites on 320 women presenting with stable symptoms suggestive of obstructive CAD and undergoing Corus CAD testing.1

Trial Design:

This clinical utility analysis was an aggregated analysis of female cohorts from the IMPACT-PCP (NCT01594411) and REGISTRY I (NCT01557855) studies. The eligibility criteria were the same in both studies: stable, non-acute, participants without diabetes presenting to PCPs in the outpatient setting with typical or atypical symptoms suggestive of obstructive CAD. Data variables merged from the two datasets included Corus CAD score, sex, age, race/ethnicity, smoking status, blood pressure, and Corus CAD-directed care referral patterns.

Primary care clinicians were allowed to incorporate the Corus CAD test results, at their own discretion, as part of their medical decision-making processes and in conjunction with other clinical information. The primary outcome of this analysis was the association between Corus CAD scores and referrals for further cardiac evaluation (referral to cardiology or advanced cardiac testing). Participants were followed for safety after the diagnostic workup in both clinical utility studies.

Key Findings:

The referral rate for further cardiac evaluation was 4.0% (10/248) for women with low Corus CAD scores versus 83.3% (60/72) for women with elevated Corus CAD scores (OR=0.008, p value <0.0001). The overall MACE/revascularization rate on median follow-up was 1.2%.* After adjusting for clinical covariates, women with low Corus CAD scores were significantly less likely to be referred for further cardiac evaluation (OR=0.013, p <0.0001).

Status:

Published, Menopause. 2015 Apr 6 [Epub ahead of print]

Identifier:

N/A

 

Aggregated Analysis: Subgroup of Women in Two Clinical Utility Studies (n=320)

 

Not Referred (%)

Referred (%)

 

Corus CAD (≤15)
N=248, 78%

238 (96%)

10 (4%)

OR = 0.008
p-value <0.0001

Corus CAD (>15)
N=72, 22%

12 (17%)

60 (83%)

 

Study

Safety: # Events

IMPACT-PCP

1
(30 days, event not related)

REGISTRY I

3
(avg. 264 days, 1 event not related)


* Median follow-up period for IMPACT-PCP = 37 days, REGISTRY I = 278 days

  1. Ladapo JA, Herman L, Weiner BH, et al. Use of a Blood Test Incorporating Age, Sex, and Gene Expression Influences Medical Decision-making in the Evaluation of Women Presenting with Symptoms Suggestive of Obstructive Coronary Artery Disease: Summary Results from Two Ambulatory Care Studies in Primary Care. Menopause. 2015 Apr 6. [Epub ahead of print] PubMed PMID: 25828395.