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

医学 冠状动脉疾病 雷加诺森 加杜布特罗 灌注 心肌灌注成像 内科学 心脏病学 核医学 磁共振成像 放射科 灌注扫描
作者
Andrew E. Arai,Jeanette Schulz‐Menger,Dipan J. Shah,Yuchi Han,W. Patricia Bandettini,Arun Abraham,Pamela K. Woodard,Joseph B. Selvanayagam,Christian Hamilton‐Craig,Ru San Tan,James Carr,Lynette Teo,Christopher M. Kramer,Bernd J. Wintersperger,Mukesh G. Harisinghani,Scott D. Flamm,Matthias G. Friedrich,Igor Klem,Subha V. Raman,Daniel Haverstock,Zheyu Liu,Guenther Brueggenwerth,Marta Santiuste,Daniel S. Berman,Dudley J. Pennell
出处
期刊:Journal of the American College of Cardiology [Elsevier BV]
卷期号:82 (19): 1828-1838 被引量:11
标识
DOI:10.1016/j.jacc.2023.08.046
摘要

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).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.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.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.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.
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