Central core laboratory versus site interpretation of coronary CT angiography: Agreement and association with cardiovascular events in the PROMISE Trial

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

    Research output: Contribution to journalArticle

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    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 6 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.

    Original languageEnglish (US)
    Pages (from-to)87-95
    Number of pages9
    JournalRadiology
    Volume287
    Issue number1
    DOIs
    StatePublished - Apr 1 2018

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    Chest Pain
    Multicenter Studies
    Angiography
    Coronary Artery Disease
    Myocardial Infarction
    Confidence Intervals
    Pathologic Constriction

    ASJC Scopus subject areas

    • Radiology Nuclear Medicine and imaging

    Cite this

    Central core laboratory versus site interpretation of coronary CT angiography : Agreement and association with cardiovascular events in the PROMISE Trial. / Lu, Michael T.; Meyersohn, Nandini M.; Mayrhofer, Thomas; Bittner, Daniel O.; Emami, Hamed; Puchner, Stefan B.; Foldyna, Borek; Mueller, Martin E.; Hearne, Steven; Yang, Clifford; Achenbach, Stephan; Truong, Quynh A.; Ghoshhajra, Brian B.; Patel, Manesh R.; Ferencik, Maros; Douglas, Pamela S.; Hoffmann, Udo.

    In: Radiology, Vol. 287, No. 1, 01.04.2018, p. 87-95.

    Research output: Contribution to journalArticle

    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 2018, '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, pp. 87-95. https://doi.org/10.1148/radiol.2017172181
    Lu, Michael T. ; Meyersohn, Nandini M. ; Mayrhofer, Thomas ; Bittner, Daniel O. ; Emami, Hamed ; Puchner, Stefan B. ; Foldyna, Borek ; Mueller, Martin E. ; Hearne, Steven ; Yang, Clifford ; Achenbach, Stephan ; Truong, Quynh A. ; Ghoshhajra, Brian B. ; Patel, Manesh R. ; Ferencik, Maros ; Douglas, Pamela S. ; Hoffmann, Udo. / Central core laboratory versus site interpretation of coronary CT angiography : Agreement and association with cardiovascular events in the PROMISE Trial. In: Radiology. 2018 ; Vol. 287, No. 1. pp. 87-95.
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    title = "Central core laboratory versus site interpretation of coronary CT angiography: Agreement and association with cardiovascular events in the PROMISE Trial",
    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 6 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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    T1 - Central core laboratory versus site interpretation of coronary CT angiography

    T2 - Agreement and association with cardiovascular events in the PROMISE Trial

    AU - Lu, Michael T.

    AU - Meyersohn, Nandini M.

    AU - Mayrhofer, Thomas

    AU - Bittner, Daniel O.

    AU - Emami, Hamed

    AU - Puchner, Stefan B.

    AU - Foldyna, Borek

    AU - Mueller, Martin E.

    AU - Hearne, Steven

    AU - Yang, Clifford

    AU - Achenbach, Stephan

    AU - Truong, Quynh A.

    AU - Ghoshhajra, Brian B.

    AU - Patel, Manesh R.

    AU - Ferencik, Maros

    AU - Douglas, Pamela S.

    AU - Hoffmann, Udo

    PY - 2018/4/1

    Y1 - 2018/4/1

    N2 - 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 6 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.

    AB - 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 6 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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