Clinical and Economic Implications of Inconclusive Noninvasive Test Results in Stable Patients With Suspected Coronary Artery Disease: Insights From the PROMISE Trial.

BACKGROUND

Inconclusive noninvasive tests complicate the care of patients with suspected coronary artery disease, but their prevalence and impact on management, outcomes, and costs are not well described.

METHODS

PROMISE (Prospective Multicenter Imaging Study for Evaluation of Chest Pain) patients were randomized to stress testing (n=4533) or computed tomographic angiography (CTA; n=4677). We assessed relationships between inconclusive results, subsequent testing, a composite outcome (death, myocardial infarction, or hospitalization for unstable angina), and healthcare expenditures.

RESULTS

Overall, 8.0% of tests were inconclusive (9.7% stress, 6.4% CTA). Compared with negative tests, inconclusive tests were more often referred to a second noninvasive test (stress: 14.6% versus 8.5%, odds ratio [OR], 1.91; CTA: 36.5% versus 8.4%, OR, 5.95; <0.001) and catheterization (stress: 5.5% versus 2.4%, OR, 2.36; CTA: 23.4% versus 4.1%, OR, 6.49; <0.001), and composite outcomes were higher for both inconclusive tests (stress: 3.7% versus 2.0%, hazard ratio, 1.81, =0.034; CTA: 5.0% versus 2.2%, hazard ratio, 1.85; =0.044) and positive tests (stress: 8.3% versus 2.0%, hazard ratio, 3.50; CTA: 9.2% versus 2.2%, hazard ratio, 3.66; <0.001). Twenty-four-month costs were higher for inconclusive tests than negative tests by $2905 (stress) and $4030 (CTA).

CONCLUSIONS

Among patients with stable chest pain undergoing a noninvasive test, inconclusive results occurred in 6% of CTA and 10% of stress tests. Compared with those with conclusive negative tests, individuals with inconclusive results more often underwent subsequent testing, had increased medical costs, and experienced worse outcomes. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01174550.