Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2023 Nov 7;82(19):1828-1838.
doi: 10.1016/j.jacc.2023.08.046.

Stress Perfusion Cardiac Magnetic Resonance vs SPECT Imaging for Detection of Coronary Artery Disease

Andrew E Arai  1 , Jeanette Schulz-Menger  2 , Dipan J Shah  3 , Yuchi Han  4 , W Patricia Bandettini  5 , Arun Abraham  6 , Pamela K Woodard  7 , Joseph B Selvanayagam  8 , Christian Hamilton-Craig  9 , Ru-San Tan  10 , James Carr  11 , Lynette Teo  12 , Christopher M Kramer  13 , Bernd J Wintersperger  14 , Mukesh G Harisinghani  15 , Scott D Flamm  16 , Matthias G Friedrich  17 , Igor Klem  18 , Subha V Raman  19 , Daniel Haverstock  20 , Zheyu Liu  20 , Guenther Brueggenwerth  21 , Marta Santiuste  20 , Daniel S Berman  22 , Dudley J Pennell  23
Affiliations
Free article
Clinical Trial

Stress Perfusion Cardiac Magnetic Resonance vs SPECT Imaging for Detection of Coronary Artery Disease

Andrew E Arai et al. J Am Coll Cardiol. .
Free article

Abstract

Background: GadaCAD2 was 1 of 2 international, multicenter, prospective, Phase 3 clinical trials that led to U.S. Food and Drug Administration approval of gadobutrol to assess myocardial perfusion and late gadolinium enhancement (LGE) in adults with known or suspected coronary artery disease (CAD).

Objectives: A prespecified secondary objective was to determine if stress perfusion cardiovascular magnetic resonance (CMR) was noninferior to single-photon emission computed tomography (SPECT) for detecting significant CAD and for excluding significant CAD.

Methods: Participants with known or suspected CAD underwent a research rest and stress perfusion CMR that was compared with a gated SPECT performed using standard clinical protocols. For CMR, adenosine or regadenoson served as vasodilators. The total dose of gadobutrol was 0.1 mmol/kg body weight. The standard of reference was a 70% stenosis defined by quantitative coronary angiography (QCA). A negative coronary computed tomography angiography could exclude CAD. Analysis was per patient. CMR, SPECT, and QCA were evaluated by independent central core lab readers blinded to clinical information.

Results: Participants were predominantly male (61.4% male; mean age 58.9 ± 10.2 years) and were recruited from the United States (75.0%), Australia (14.7%), Singapore (5.7%), and Canada (4.6%). The prevalence of significant CAD was 24.5% (n = 72 of 294). Stress perfusion CMR was statistically superior to gated SPECT for specificity (P = 0.002), area under the receiver operating characteristic curve (P < 0.001), accuracy (P = 0.003), positive predictive value (P < 0.001), and negative predictive value (P = 0.041). The sensitivity of CMR for a 70% QCA stenosis was noninferior and nonsuperior to gated SPECT.

Conclusions: Vasodilator stress perfusion CMR, as performed with gadobutrol 0.1 mmol/kg body weight, had superior diagnostic accuracy for diagnosis and exclusion of significant CAD vs gated SPECT.

Keywords: coronary artery disease; magnetic resonance imaging; myocardial ischemia; myocardial perfusion imaging; single-photon emission computed tomography.

PubMed Disclaimer

Conflict of interest statement

Funding Support and Author Disclosures Funding was provided by Bayer AG, Siemens Healthineers, and in part by the Division of Intramural Research, National Heart, Lung, and Blood Institute, National Institutes of Health. Dr Arai had a Cooperative Research and Development Agreement (CRADA) with Bayer, Siemens, and Circle CVI Inc; and has patents and invention reports related to perfusion quantification and cine MRI. Dr Schulz-Menger has served as an advisor for Bayer. Dr Berman has served as a consultant for Bayer. Dr Han has received research grants from Gilead Sciences and General Electric; has served as a consultant for Acceleron, Bracco, and Complexa; and has served on the Speakers Bureau of General Electric, all unrelated to this work. Dr Gutberlet has received speaker honorarium from Bayer, Bracco, Circle CVI, Philips, and Siemens. Dr Woodard has received research support from Bayer, Lilly, and Roche; had a research agreement with Siemens; and has served as a consultant for Medtronic. Dr Carr has received institutional research grants from Siemens, Bayer, and Guerbet; has received speaker honoraria from Bayer and Guerbet; and has received served on advisory boards of Siemens, Bayer, and Bracco. Dr Friedrich has received grants and personal fees from Circle Cardiovascular Imaging Inc, outside of the submitted work. Drs. Haverstock, Liu, Brueggenwerth, and Santiuste were employees of Bayer. Dr Pennell has received research support from Siemens, ApoPharma Apotex, La Jolla, and Bayer; and has served as a consultant for Apotex, La Jolla, and Bayer. All other authors have reported that they had no relationships relevant to the contents of this paper to disclose.

Comment in

Publication types

MeSH terms