title: 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.
abstract: Guidelines recommend noninvasive testing for patients with stable chest pain, although many subsequently have normal test results and no adverse clinical events.
  
  
  
  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).
  
  
  
  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.
  
  
  
  Patients were randomized to receive coronary computed tomography angiography (CCTA) vs functional testing.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  clinicaltrials.gov Identifier: NCT01174550.
authors.affiliation: Division of Cardiology, University of British Columbia, Vancouver, British Columbia, Canada.|Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.
authors.forename: Christopher B
authors.initials: CB
authors.lastname: Fordyce
authors.affiliation: Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.
authors.forename: Pamela S
authors.initials: PS
authors.lastname: Douglas
authors.affiliation: Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.
authors.forename: Rhonda S
authors.initials: RS
authors.lastname: Roberts
authors.affiliation: Department of Radiology, Division of Cardiovascular Imaging and Cardiac MR PET CT Program, Massachusetts General Hospital, Harvard Medical School, Boston.
authors.forename: Udo
authors.initials: U
authors.lastname: Hoffmann
authors.affiliation: Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.
authors.forename: Hussein R
authors.initials: HR
authors.lastname: Al-Khalidi
authors.affiliation: Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.
authors.forename: Manesh R
authors.initials: MR
authors.lastname: Patel
authors.affiliation: Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.
authors.forename: Christopher B
authors.initials: CB
authors.lastname: Granger
authors.affiliation: Division of Cardiology, Rutgers Robert Wood Johnson Medical School, New Brunswick, New Jersey.
authors.forename: John
authors.initials: J
authors.lastname: Kostis
authors.affiliation: Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.
authors.forename: Daniel B
authors.initials: DB
authors.lastname: Mark
authors.affiliation: Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.
authors.forename: Kerry L
authors.initials: KL
authors.lastname: Lee
authors.affiliation: The CardioVascular Center, Division of Cardiology, Tufts Medical Center, Boston, Massachusetts.
authors.forename: James E
authors.initials: JE
authors.lastname: Udelson
mesh_terms: D002637:Chest Pain / Q000175:diagnosis / Q000209:etiology*; D000072226:Computed Tomography Angiography / Q000379:methods*; D017023:Coronary Angiography / Q000379:methods*; D003324:Coronary Artery Disease / Q000150:complications / Q000175:diagnosis* / Q000453:epidemiology; D005080:Exercise Test / Q000379:methods; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D011446:Prospective Studies; D015203:Reproducibility of Results; D015996:Survival Rate / Q000639:trends; D013997:Time Factors; D014481:United States / Q000453:epidemiology