Identification of Patients With Stable Chest Pain Deriving Minimal Value From Noninvasive Testing: The PROMISE Minimal-Risk Tool, A Secondary Analysis of a Randomized Clinical Trial.

Journal Article (Journal Article;Multicenter Study)

IMPORTANCE: Guidelines recommend noninvasive testing for patients with stable chest pain, although many subsequently have normal test results and no adverse clinical events. OBJECTIVE: To describe a risk tool developed to use only pretest clinical data to identify patients with chest pain with normal coronary arteries and no clinical events during follow-up (minimal-risk cohort). DESIGN, SETTING, AND PARTICIPANTS: This secondary analysis of a randomized, pragmatic comparative effectiveness trial (Prospective Multicenter Imaging Study for Evaluation of Chest Pain [PROMISE]) includes stable, symptomatic outpatients without known coronary artery disease referred for noninvasive testing at 193 sites in North America. INTERVENTIONS: Patients were randomized to receive coronary computed tomography angiography (CCTA) vs functional testing. MAIN OUTCOMES AND MEASURES: A low-risk tool was developed and internally validated from July 27, 2010, to September 19, 2013, in 4631 patients receiving CCTA as their initial test, with a median follow-up of 25 months. Logistic regression analysis was used to evaluate pretest variables to determine factors associated with minimal risk using a two-thirds random sample for model derivation (n = 3087) and a one-third sample for testing and validation (n = 1544). The model was then applied to the CCTA and functional testing arms, and test results and event rates were ascertained. RESULTS: A total of 1243 of 4631 patients (26.8%) were in the minimal-risk cohort. The final minimal-risk model included 10 clinical variables that together were correlated with normal CCTA results and no clinical events (C statistic = 0.725 for the derivation and validation subsets; 95% CI, 0.705-0.746): younger age; female sex; racial or ethnic minority; no history of hypertension, diabetes, or dyslipidemia; family history of premature coronary artery disease; never smoking; symptoms unrelated to physical or mental stress; and higher high-density lipoprotein cholesterol level. Across the entire PROMISE cohort, this model was associated with the lowest rates of severely abnormal test results (1.3% for CCTA; 5.6% for functional) and cardiovascular death or myocardial infarction (0.5% for a median of 25 months) among patients at the highest probability (10th decile) of minimal risk. CONCLUSIONS AND RELEVANCE: In contemporary practice, more than 25% of patients with stable chest pain referred for noninvasive testing will have normal coronary arteries and no long-term clinical events. A clinical tool using readily available pretest variables discriminates such minimal-risk patients, for whom deferred testing may be considered. TRIAL REGISTRATION: Identifier: NCT01174550.

Full Text

Duke Authors

Cited Authors

  • Fordyce, CB; Douglas, PS; Roberts, RS; Hoffmann, U; Al-Khalidi, HR; Patel, MR; Granger, CB; Kostis, J; Mark, DB; Lee, KL; Udelson, JE; Prospective Multicenter Imaging Study for Evaluation of Chest Pain (PROMISE) Investigators,

Published Date

  • April 1, 2017

Published In

Volume / Issue

  • 2 / 4

Start / End Page

  • 400 - 408

PubMed ID

  • 28199464

Pubmed Central ID

  • PMC5470411

Electronic International Standard Serial Number (EISSN)

  • 2380-6591

Digital Object Identifier (DOI)

  • 10.1001/jamacardio.2016.5501


  • eng

Conference Location

  • United States