Multicenter, Intraindividual Comparison of Single-Dose Gadobenate Dimeglumine and Double-Dose Gadopentetate Dimeglumine for MR Angiography of the Supra-Aortic Arteries (the Supra-Aortic VALUE Study)

BACKGROUND AND PURPOSE: Gadobenate dimeglumine has markedly higher R1 relaxivity compared to gadopentetate dimeglumine meaning that lower doses can be used to achieve similar contrast enhancement. Our aim was to prospectively compare single-dose gadobenate dimeglumine with double-dose gadopentetate dimeglumine for contrast-enhanced MRA of the supra-aortic vasculature.

MATERIALS AND METHODS: Forty-six patients (37 men, 9 women; mean age, 63.5 ± 10.1 years) with known or suspected steno-occlusive disease of the supra-aortic vessels underwent 2 identical CE-MRA examinations at 1.5T. Contrast agents were administered in randomized order, with the 2-fold greater volume of gadopentetate dimeglumine injected at a 2 times faster rate. Image assessment was performed by 3 independent blinded readers for vessel anatomic delineation, detection/exclusion of pathology, and global preference. Diagnostic performance (sensitivity, specificity, accuracy, PPV, and NPV) for detection of ≥60% stenosis was determined for 39/46 patients who underwent preinterventional DSA. Data were analyzed by using the Wilcoxon signed-rank, McNemar, and Wald tests in terms of the noninferiority of single-dose gadobenate dimeglumine compared with double-dose gadopentetate dimeglumine. Quantitative enhancement (signal-to-noise ratio (SNR), contrast-to-noise ratio (CNR)) was also compared.

RESULTS: All images were technically adequate. No differences (P = 1.0) were noted by any reader for any qualitative parameter. All readers considered single-dose gadobenate dimeglumine and double-dose gadopentetate dimeglumine equivalent in at least 42/46 patients (91.3% three-reader agreement) for all parameters. Nonsignificant superiority for gadobenate dimeglumine was reported for all diagnostic performance indicators (sensitivity: 82.7%–88.5% versus 75.0%–80.8%; specificity: 96.4%–98.6% versus 94.6%–98.6%; accuracy: 94.6%–96.1% versus 92.4%–94.9%; PPV: 81.5%–91.5% versus 73.7%–90.7%; NPV: 96.8%–97.8% versus 95.4%–96.4%). No differences (P > .05) in quantitative enhancement were noted.

CONCLUSIONS: The image quality and diagnostic performance achieved with 0.1-mmol/kg gadobenate dimeglumine is at least equivalent to that achieved with 0.2-mmol/kg gadopentetate dimeglumine.