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dc.contributor.authorArai, AE
dc.contributor.authorSchulz-Menger, J
dc.contributor.authorBerman, D
dc.contributor.authorMahrholdt, H
dc.contributor.authorHan, Y
dc.contributor.authorBandettini, WP
dc.contributor.authorGutberlet, M
dc.contributor.authorAbraham, A
dc.contributor.authorWoodard, PK
dc.contributor.authorSelvanayagam, JB
dc.contributor.authorMcCann, GP
dc.contributor.authorHamilton-Craig, C
dc.contributor.authorSchoepf, UJ
dc.contributor.authorSan Tan, R
dc.contributor.authoret al.
dc.date.accessioned2020-10-01T05:54:15Z
dc.date.available2020-10-01T05:54:15Z
dc.date.issued2020
dc.identifier.issn0735-1097
dc.identifier.doi10.1016/j.jacc.2020.07.060
dc.identifier.urihttp://hdl.handle.net/10072/398066
dc.description.abstractBackground: 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.
dc.description.peerreviewedYes
dc.languageEnglish
dc.language.isoeng
dc.publisherElsevier
dc.relation.ispartofpagefrom1536
dc.relation.ispartofpageto1547
dc.relation.ispartofissue13
dc.relation.ispartofjournalJournal of the American College of Cardiology
dc.relation.ispartofvolume76
dc.subject.fieldofresearchCardiorespiratory Medicine and Haematology
dc.subject.fieldofresearchPublic Health and Health Services
dc.subject.fieldofresearchcode1102
dc.subject.fieldofresearchcode1117
dc.subject.keywordsCMR
dc.subject.keywordscoronary artery disease
dc.subject.keywordsgadobutrol
dc.subject.keywordsmyocardial infarction
dc.subject.keywordsmyocardial perfusion
dc.titleGadobutrol-Enhanced Cardiac Magnetic Resonance Imaging for Detection of Coronary Artery Disease
dc.typeJournal article
dc.type.descriptionC1 - Articles
dcterms.bibliographicCitationArai, AE; Schulz-Menger, J; Berman, D; Mahrholdt, H; Han, Y; Bandettini, WP; Gutberlet, M; Abraham, A; Woodard, PK; Selvanayagam, JB; McCann, GP; Hamilton-Craig, C; Schoepf, UJ; San Tan, R; et al., Gadobutrol-Enhanced Cardiac Magnetic Resonance Imaging for Detection of Coronary Artery Disease, Journal of the American College of Cardiology, 2020, 76 (13), pp. 1536-1547
dcterms.dateAccepted2020-07-29
dcterms.licensehttp://creativecommons.org/licenses/by/4.0/
dc.date.updated2020-09-30T22:24:51Z
dc.description.versionVersion of Record (VoR)
gro.rights.copyright© The Author(s) 2020. Published by Elsevier on behalf of the American College of Cardiology Foundation. This is an Open Access article distributed under the terms of the Creative Commons Attribution 4.0 International License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
gro.hasfulltextFull Text
gro.griffith.authorHamilton-Craig, Christian


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