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).
OBJECTIVE
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.


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.


CONCLUSIONS
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.
Radiology Department, Shanghai Changhai Hospital, Shanghai, China.
Jian
J
Wang
Fuhua
F
Yan
Jianyu
J
Liu
Jianping
J
Lu
Dan
D
Li
Jingyuan
J
Luan
Xiaoying
X
Wang
Yuan
Y
Li
Roberto
R
Iezzi
Francesco
F
De Cobelli
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001158:Arteries / Q000473:pathology*; D003287:Contrast Media / Q000737:chemistry; D018592:Cross-Over Studies; D005260:Female; D019786:Gadolinium DTPA / Q000008:administration & dosage*; D006801:Humans; D007091:Image Processing, Computer-Assisted; D018810:Magnetic Resonance Angiography; D008297:Male; D008536:Meglumine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D008875:Middle Aged; D015588:Observer Variation; D009942:Organometallic Compounds / Q000008:administration & dosage*; D011237:Predictive Value of Tests; D011446:Prospective Studies; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D055815:Young Adult
D003287:Contrast Media; D009942:Organometallic Compounds; C064572:gadobenic acid; D008536:Meglumine; D019786:Gadolinium DTPA
comparative studies; contrast-enhanced MR angiography; gadolinium contrast agents; peripheral arteries