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; P<0.001) and catheterization (stress: 5.5% versus 2.4%, OR, 2.36; CTA: 23.4% versus 4.1%, OR, 6.49; P<0.001), and composite outcomes were higher for both inconclusive tests (stress: 3.7% versus 2.0%, hazard ratio, 1.81, P=0.034; CTA: 5.0% versus 2.2%, hazard ratio, 1.85; P=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; P<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.

RCT Entities:   Population Interventions Outcomes