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Lu MT, Meyersohn NM, Mayrhofer T, et al. Central Core Laboratory versus Site Interpretation of Coronary CT Angiography: Agreement and Association with Cardiovascular Events in the PROMISE Trial. Radiology. 2017;287(1):87-95doi: 10.1148/radiol.2017172181.
Lu, M. T., Meyersohn, N. M., Mayrhofer, T., Bittner, D. O., Emami, H., Puchner, S. B., Foldyna, B., Mueller, M. E., Hearne, S., Yang, C., Achenbach, S., Truong, Q. A., Ghoshhajra, B. B., Patel, M. R., Ferencik, M., Douglas, P. S., & 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, et al. "Central Core Laboratory versus Site Interpretation of Coronary CT Angiography: Agreement and Association with Cardiovascular Events in the PROMISE Trial." Radiology vol. 287,1 (2018): 87-95. doi: https://doi.org/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. doi: 10.1148/radiol.2017172181. Epub 2017 Nov 27. PMID: 29178815; PMCID: PMC5881637.
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Radiology. 2018 Apr;287(1):87-95. doi: 10.1148/radiol.2017172181. Epub 2017 Nov 27.

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

Radiology

Michael T Lu, Nandini M Meyersohn, Thomas Mayrhofer, Daniel O Bittner, Hamed Emami, Stefan B Puchner, Borek Foldyna, Martin E Mueller, Steven Hearne, Clifford Yang, Stephan Achenbach, Quynh A Truong, Brian B Ghoshhajra, Manesh R Patel, Maros Ferencik, Pamela S Douglas, Udo Hoffmann

Affiliations

  1. From the Cardiac PET MR CT Program, Massachusetts General Hosp and Harvard Medical School, Boston, Mass (M.T.L., N.M.M., T.M., D.O.B., H.E., S.B.P., B.B.G., B.F., M.E.M., M.F., U.H.); School of Business Studies, Stralsund Univ of Applied Sciences, Stralsund, Germany (T.M.); Dept of Internal Medicine (Cardiology), Friedrich Alexander Univ Hosp, Erlangen, Germany (D.O.B., S.A.); Dept of Angiography and Interventional Radiology, Medical Univ Vienna, Vienna, Austria (S.B.P.); Delmarva Health LLC, Salisbury, Md (S.H.); Dept of Radiology, Univ of Connecticut Health Ctr, Farmington, Conn (C.Y.); Dalio Institute of Cardiovascular Imaging, Weill Cornell Medical College, New York, NY (Q.A.T.); Duke Clinical Research Inst, Duke Univ School of Medicine, Durham, NC (M.R.P., P.S.D.); and Knight Cardiovascular Inst, Oregon Health & Science Univ, Portland, Ore (M.F.).

PMID: 29178815 PMCID: PMC5881637 DOI: 10.1148/radiol.2017172181

Abstract

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.

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