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Multicenter, intra‐individual comparison of single dose gadobenate dimeglumine and double dose gadopentetate dimeglumine for MR angiography of the peripheral arteries (the Peripheral VALUE Study)
Author(s) -
Wang Jian,
Yan Fuhua,
Liu Jianyu,
Lu Jianping,
Li Dan,
Luan Jingyuan,
Wang Xiaoying,
Li Yuan,
Iezzi Roberto,
Cobelli Francesco
Publication year - 2013
Publication title -
journal of magnetic resonance imaging
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.563
H-Index - 160
eISSN - 1522-2586
pISSN - 1053-1807
DOI - 10.1002/jmri.24040
Subject(s) - peripheral , medicine , nuclear medicine , radiology , angiography
Purpose To prospectively compare single dose gadobenate dimeglumine with double dose gadopentetate dimeglumine for CE‐MRA in patients with peripheral arterial occlusive disease (PAOD) using an intra‐individual crossover study design in which all patients received both contrast agents in otherwise identical CE‐MRA examinations. Materials and Methods Institutional review board and regulatory approval were granted and all patients provided written informed consent. Sixty‐eight patients (53M/15F; 62.4 ± 15.7 years) with mild‐to‐severe PAOD were enrolled for randomized 3‐station CE‐MRA with 0.1 mmol/kg gadobenate dimeglumine and 0.2 mmol/kg gadopentetate dimeglumine. Three blinded readers assessed images for vessel anatomical delineation, disease detection/exclusion, and global preference. Diagnostic performance for detection of ≥51% stenosis was determined for 53 patients who underwent DSA. Noninferiority was assessed using the Wilcoxon Signed Rank, McNemar, and Wald tests. Quantitative enhancement was compared. Results No differences ( P ≥ 0.25) were noted for any qualitative parameter at any station. Equivalence was reported in at least 62/64 patients (93.8% 3‐reader agreement) for diagnostic preference. Superiority for gadobenate dimeglumine was reported by all readers for diagnostic performance (sensitivity: 80.4–88.0% versus 75.2–85.8%; specificity: 89.8–96.0% versus 88.7–94.8%; accuracy: 87.4–91.7% versus 84.9–90.6%; PPV: 84.0–92.8% versus 82.3–90.8%; NPV: 88.5–92.4% versus 85.7–91.1%). Quantitative enhancement was similar in the pelvis but significantly ( P < 0.05) greater with gadobenate dimeglumine in the thigh for two readers. Conclusion Image quality and diagnostic performance on peripheral CE‐MRA with 0.1 mmol/kg gadobenate dimeglumine is at least equivalent to that with 0.2 mmol/kg gadopentetate dimeglumine. J. Magn. Reson. Imaging 2013;38:926–937. © 2013 Wiley Periodicals, Inc.