Gadobutrol-Enhanced Cardiac Magnetic Resonance Imaging for Detection of Coronary Artery Disease

Andrew E. Arai, Jeanette Schulz-Menger, Daniel Berman, Heiko Mahrholdt, Yuchi Han, W. Patricia Bandettini, Matthias Gutberlet, Arun Abraham, Pamela K. Woodard, Joseph B. Selvanayagam, Gerry McCann, Christian Hamilton-Craig, U. Joseph Schoepf, Ru San Tan, Christopher M. Kramer, Matthias G. Friedrich, Daniel Haverstock, Zheyu Liu, Guenther Brueggenwerth, Claudia Bacher-StierMarta Santiuste, Dudley J. Pennell, GadaCAD Investigators

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Abstract

Background: Gadolinium-based contrast agents were not approved in the United States for detecting coronary artery disease (CAD) prior to the current studies. Objectives: The purpose of this study was to determine the sensitivity and specificity of gadobutrol for detection of CAD by assessing myocardial perfusion and late gadolinium enhancement (LGE) imaging. Methods: Two international, single-vendor, phase 3 clinical trials of near identical design, “GadaCAD1” and “GadaCAD2,” were performed. Cardiovascular magnetic resonance (CMR) included gadobutrol-enhanced first-pass vasodilator stress and rest perfusion followed by LGE imaging. CAD was defined by quantitative coronary angiography (QCA) but computed tomography coronary angiography could exclude significant CAD. Results: Because the design and results for GadaCAD1 (n = 376) and GadaCAD2 (n = 388) were very similar, results were summarized as a fixed-effect meta-analysis (n = 764). The prevalence of CAD was 27.8% defined by a ≥70% QCA stenosis. For detection of a ≥70% QCA stenosis, the sensitivity of CMR was 78.9%, specificity was 86.8%, and area under the curve was 0.871. The sensitivity and specificity for multivessel CAD was 87.4% and 73.0%. For detection of a 50% QCA stenosis, sensitivity was 64.6% and specificity was 86.6%. The optimal threshold for detecting CAD was a ≥67% QCA stenosis in GadaCAD1 and ≥63% QCA stenosis in GadaCAD2. Conclusions: Vasodilator stress and rest myocardial perfusion CMR and LGE imaging had high diagnostic accuracy for CAD in 2 phase 3 clinical trials. These findings supported the U.S. Food and Drug Administration approval of gadobutrol-enhanced CMR (0.1 mmol/kg) to assess myocardial perfusion and LGE in adult patients with known or suspected CAD.

Original languageEnglish
Pages (from-to)1536-1547
Number of pages12
JournalJournal of The American College of Cardiology
Volume76
Issue number13
DOIs
Publication statusPublished - 29 Sep 2020

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Keywords

  • CMR
  • coronary artery disease
  • gadobutrol
  • myocardial infarction
  • myocardial perfusion

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    Arai, A. E., Schulz-Menger, J., Berman, D., Mahrholdt, H., Han, Y., Bandettini, W. P., Gutberlet, M., Abraham, A., Woodard, P. K., Selvanayagam, J. B., McCann, G., Hamilton-Craig, C., Schoepf, U. J., San Tan, R., Kramer, C. M., Friedrich, M. G., Haverstock, D., Liu, Z., Brueggenwerth, G., ... GadaCAD Investigators (2020). Gadobutrol-Enhanced Cardiac Magnetic Resonance Imaging for Detection of Coronary Artery Disease. Journal of The American College of Cardiology, 76(13), 1536-1547. https://doi.org/10.1016/j.jacc.2020.07.060