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Central Core Laboratory versus Site Interpretation of Coronary CT Angiography: Agreement and Association with Cardiovascular Events in the PROMISE Trial.

Publication ,  Journal Article
Lu, MT; Meyersohn, NM; Mayrhofer, T; Bittner, DO; Emami, H; Puchner, SB; Foldyna, B; Mueller, ME; Hearne, S; Yang, C; Achenbach, S; Truong, QA ...
Published in: Radiology
April 2018

Purpose To assess concordance and relative prognostic utility between central core laboratory and local site interpretation for significant coronary artery disease (CAD) and cardiovascular events. Materials and Methods In the Prospective Multicenter Imaging Study for Evaluation of Chest Pain (PROMISE) trial, readers at 193 North American sites interpreted coronary computed tomographic (CT) angiography as part of the clinical evaluation of stable chest pain. Readers at a central core laboratory also interpreted CT angiography blinded to clinical data, site interpretation, and outcomes. Significant CAD was defined as stenosis greater than or equal to 50%; cardiovascular events were defined as a composite of cardiovascular death or myocardial infarction. Results In 4347 patients (51.8% women; mean age ± standard deviation, 60.4 years ± 8.2), core laboratory and site interpretations were discordant in 16% (683 of 4347), most commonly because of a finding of significant CAD by site but not by core laboratory interpretation (80%, 544 of 683). Overall, core laboratory interpretation resulted in 41% fewer patients being reported as having significant CAD (14%, 595 of 4347 vs 23%, 1000 of 4347; P < .001). Over a median follow-up period of 25 months, 1.3% (57 of 4347) sustained myocardial infarction or cardiovascular death. The C statistic for future myocardial infarction or cardiovascular death was 0.61 (95% confidence interval [CI]: 0.54, 0.68) for the core laboratory and 0.63 (95% CI: 0.56, 0.70) for the sites. Conclusion Compared with interpretation by readers at 193 North American sites, standardized core laboratory interpretation classified 41% fewer patients as having significant CAD. © RSNA, 2017 Online supplemental material is available for this article. Clinical trial registration no. NCT01174550.

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Published In

Radiology

DOI

EISSN

1527-1315

Publication Date

April 2018

Volume

287

Issue

1

Start / End Page

87 / 95

Location

United States

Related Subject Headings

  • Retrospective Studies
  • Prospective Studies
  • Nuclear Medicine & Medical Imaging
  • Middle Aged
  • Male
  • Humans
  • Female
  • Coronary Artery Disease
  • Coronary Angiography
  • Computed Tomography Angiography
 

Citation

APA
Chicago
ICMJE
MLA
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Lu, M. T., Meyersohn, N. M., Mayrhofer, T., Bittner, D. O., Emami, H., Puchner, S. B., … Hoffmann, U. (2018). Central Core Laboratory versus Site Interpretation of Coronary CT Angiography: Agreement and Association with Cardiovascular Events in the PROMISE Trial. Radiology, 287(1), 87–95. https://doi.org/10.1148/radiol.2017172181
Lu, Michael T., Nandini M. Meyersohn, Thomas Mayrhofer, Daniel O. Bittner, Hamed Emami, Stefan B. Puchner, Borek Foldyna, et al. “Central Core Laboratory versus Site Interpretation of Coronary CT Angiography: Agreement and Association with Cardiovascular Events in the PROMISE Trial.Radiology 287, no. 1 (April 2018): 87–95. https://doi.org/10.1148/radiol.2017172181.
Lu MT, Meyersohn NM, Mayrhofer T, Bittner DO, Emami H, Puchner SB, et al. Central Core Laboratory versus Site Interpretation of Coronary CT Angiography: Agreement and Association with Cardiovascular Events in the PROMISE Trial. Radiology. 2018 Apr;287(1):87–95.
Lu, Michael T., et al. “Central Core Laboratory versus Site Interpretation of Coronary CT Angiography: Agreement and Association with Cardiovascular Events in the PROMISE Trial.Radiology, vol. 287, no. 1, Apr. 2018, pp. 87–95. Pubmed, doi:10.1148/radiol.2017172181.
Lu MT, Meyersohn NM, Mayrhofer T, Bittner DO, Emami H, Puchner SB, Foldyna B, Mueller ME, Hearne S, Yang C, Achenbach S, Truong QA, Ghoshhajra BB, Patel MR, Ferencik M, Douglas PS, Hoffmann U. Central Core Laboratory versus Site Interpretation of Coronary CT Angiography: Agreement and Association with Cardiovascular Events in the PROMISE Trial. Radiology. 2018 Apr;287(1):87–95.

Published In

Radiology

DOI

EISSN

1527-1315

Publication Date

April 2018

Volume

287

Issue

1

Start / End Page

87 / 95

Location

United States

Related Subject Headings

  • Retrospective Studies
  • Prospective Studies
  • Nuclear Medicine & Medical Imaging
  • Middle Aged
  • Male
  • Humans
  • Female
  • Coronary Artery Disease
  • Coronary Angiography
  • Computed Tomography Angiography