MR Angiography at 3 T of Peripheral Arterial Disease: A Randomized Prospective Comparison of Gadoterate Meglumine and Gadobutrol(391 views) Loewe C, Arnaiz J, Krause D, Marti-bonmati L, Haneder S, Kramer U, Dalia Study Group , Lell M, Lonjedo E, Tartaro A, Aschauer M, Burrel M, Lombardi M, Izzillo R, Mainenti PP, Heautot JF, Leicher-düber A, Krug B, Arteaga C
Am J Roentgenol (ISSN: 0361-803x), 2015 Jun; 204(6): 1311-1321.
1 Section of Cardiovascular and Interventional Radiology, Department of Bioimaging and Image-Guided Therapy, Medical University of Vienna, Waehringer Guertel 18-20, Vienna 1090, Austria.,
References: Not available.
MR Angiography at 3 T of Peripheral Arterial Disease: A Randomized Prospective Comparison of Gadoterate Meglumine and Gadobutrol
OBJECTIVE: This large-scale randomized study aimed to show the noninferiority in terms of diagnostic performance of gadoterate meglumine-enhanced versus gadobutrol-enhanced 3-T MR angiography (MRA) using digital subtraction angiography (DSA) as the reference standard in patients with peripheral arterial occlusive disease (PAOD). SUBJECTS AND METHODS: In this prospective international randomized double-blind phase IV trial, 189 patients were enrolled. Of them, 156 could be included in the per-protocol population for on-site assessments and 154 for off-site readings. Subjects underwent peripheral MRA, after injection of 0.1 mmol/kg of either gadoterate meglumine or gadobutrol, and DSA within 30 days. The diagnostic accuracy was evaluated and compared using a noninferiority analysis. Secondary endpoints included sensitivity, specificity, diagnostic confidence, contrast-to-noise ratio, and signal-to-noise ratio evaluations. RESULTS: The percentage agreement between MRA and DSA for stenosis detection was similar for on-site readings for both groups (mean +/- SD, 80.6% +/- 16.1% with gadoterate meglumine vs 77.1% +/- 19.6% with gadobutrol; 3.5% difference), and the same was true for off-site readings (73.9% +/- 16.9% with gadoterate meglumine vs 75.1% +/- 13.8% with gadobutrol; 1.1% difference). The noninferiority of gadoterate meglumine to gadobutrol was shown for both on- and off-site readings. Sensitivity in detecting significant stenosis (> 50%) was 72.3% for gadoterate meglumine versus 70.6% for gadobutrol, whereas specificity (92.6% vs 92.3%), diagnostic confidence (87.0% vs 86.0%), signal-to-noise ratio (165.5 vs 161.0), and contrast-to-noise ratio (159.5 vs 155.3) did not differ statistically significantly between the two groups. CONCLUSION: Gadoterate meglumine was found to be not inferior to gadobutrol in terms of diagnostic performance in patients with PAOD undergoing 3-T contrast-enhanced MRA. No statistically significant differences were detected between the two MRA groups.
MR Angiography at 3 T of Peripheral Arterial Disease: A Randomized Prospective Comparison of Gadoterate Meglumine and Gadobutrol
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