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| Item Type: | Article |
|---|---|
| Title: | Gadobutrol-enhanced cardiac magnetic resonance imaging for detection of coronary artery disease |
| Creators Name: | 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.P., Hamilton-Craig, C., Schoepf, U.J., Tan, R.S., Kramer, C.M., Friedrich, M.G., Haverstock, D., Liu, Z., Brueggenwerth, G., Bacher-Stier, C., Santiuste, M. and Pennell, D.J. |
| 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. |
| Keywords: | Coronary Artery Disease, CMR, Gadobutrol, Myocardial Infarction, Myocardial Perfusion |
| Source: | Journal of the American College of Cardiology |
| ISSN: | 0735-1097 |
| Publisher: | Elsevier |
| Volume: | 76 |
| Number: | 13 |
| Page Range: | 1536-1547 |
| Date: | 29 September 2020 |
| Official Publication: | https://doi.org/10.1016/j.jacc.2020.07.060 |
| PubMed: | View item in PubMed |
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