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)

Abstract

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.

Trial registration: ClinicalTrials.gov NCT01260636.

Figures

Fig. 1.

Mean signal-to-noise ratio (A) and contrast-to-noise ratio (B) after 0.1-mmol/kg gadobenate dimeglumine and 0.2 mmol/kg gadopentetate dimeglumine as determined by 3 independent blinded readers.

Fig. 2.

A 72-year-old male patient referred for MR imaging to guide revascularization of symptomatic carotid artery stenosis. The MIP image (A) acquired after 0.1-mmol/kg gadobenate dimeglumine (8 mL injected at 0.8 mL/s) reveals severe stenosis in both the left and right subclavian arteries (open arrows) and a ≥60% stenosis (closed arrow) of the right carotid bifurcation/ICA. Similar findings are seen on the analogous MIP image (B) acquired after 0.2-mmol/kg gadopentetate dimeglumine (16 mL injected at 1.6 mL/s). Selective DSA of the right carotid bifurcation/ICA (C) confirms the findings of the CE-MRA examinations after gadobenate dimeglumine (D) and gadopentetate dimeglumine (E). Note the sharper vessel delineation and greater contrast enhancement achieved with gadobenate dimeglumine.

Fig. 3.

A 62-year-old male patient referred for MR imaging to guide revascularization of symptomatic carotid artery stenosis. The MIP image (A) acquired after 0.1-mmol/kg gadobenate dimeglumine (12 mL injected at 1.2 mL/s) reveals occlusion of the right carotid bifurcation and right ICA (open arrow) and a ≥60% stenosis (closed arrow) of the left carotid bifurcation. Similar findings are seen on the analogous MIP image (B) acquired after 0.2-mmol/kg gadopentetate dimeglumine (24 mL injected at 2.4 mL/s). There is no improvement in image quality or disease/vessel delineation with the higher dose of gadopentetate dimeglumine. DSA (C) confirms the findings of the MRA examinations.