MR angiography at 3 T of peripheral arterial disease

• Verfasst von: Loewe, Christian [VerfasserIn]
• Verfasst von: Haneder, Stefan [VerfasserIn]
• Titel: MR angiography at 3 T of peripheral arterial disease
• Titelzusatz: a randomized prospective comparison of gadoterate meglumine and gadobutrol
• Verf.angabe: Christian Loewe, Javier Arnaiz, Denis Krause, Luis Marti-Bonmati, Stefan Haneder, Ulrich Kramer, for the DALIA study group
• E-Jahr: 2015
• Jahr: June 2015
• Umfang: 11 S.
• Fussnoten: Gesehen am 08.01.2018
• Titel Quelle: Enthalten in: American journal of roentgenology
• Ort Quelle: Leesburg, Va. : American Roentgen Ray Society, 1965
• Jahr Quelle: 2015
• Band/Heft Quelle: 204(2015), 6, Seite 1311-1321
• ISSN Quelle: 1546-3141
• DOI: doi:10.2214/AJR.14.12604
• Datenträger: Online-Ressource
• Sprache: eng
• Sach-SW: 3 T
• Sach-SW: gadobutrol
• Sach-SW: gadoterate meglumine
• Sach-SW: MR angiography
• Sach-SW: peripheral arterial occlusive disease
• K10plus-PPN: 1566928788

Abstract

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.