Gadobenate dimeglumine and gadofosveset trisodium for MR angiography of the renal arteries: Multicenter intraindividual crossover comparison.
OBJECTIVE
This prospective multicenter intraindividual crossover study was designed to compare gadobenate dimeglumine and gadofosveset trisodium at approved doses with respect to the image quality and diagnostic performance of contrast-enhanced MR angiography (CE-MRA) in the detection of clinically relevant renal artery stenosis.


METHODS
Thirty-nine subjects (17 men, 22 women; age range, 30-86 years; mean 62 +/- 13.3 [SD] years) with known or suspected renovascular disease underwent a first CE-MRA examination with 0.1 mmol/kg gadobenate dimeglumine and a second examination 3-12 days later with 0.03 mmol/kg gadofosveset. Identical T1-weighted spoiled gradient-refocused echo coronal first-pass images were acquired for 38 of the 39 patients. For 15 of the 38 patients, additional sagittal or axial images or both were acquired with gadofosveset during the steady-state phase. Thirty-four patients underwent digital subtraction angiography, which was the reference standard. Three independent blinded readers assessed source images and maximum-intensity-projection reconstructions to detect clinically relevant (> 50%) renal artery stenosis. Diagnostic performance (sensitivity, specificity, accuracy, positive and negative predictive values) was evaluated with the McNemar and Wald tests. Matched-pair determinations of diagnostic preference were evaluated with Wilcoxon's signed rank test. Reader agreement was determined with kappa analysis, and safety was assessed.


RESULTS
Comparison of first-pass images revealed superior sensitivity (75.7-86.5% vs 68.4-76.3%), specificity (92.1-98.6% vs 90.5-93.9%), accuracy (88.9-96.2% vs 85.9-90.3%), positive predictive value (70.0-94.1% vs 65.0-76.3%), and negative predictive value (94.0-96.6% vs 91.7-93.9%) with gadobenate dimeglumine. Significant superiority was noted for specificity (p < or = 0.02), accuracy (p < or = 0.005), and positive predictive value (p < or = 0.018). Steady-state images showed no benefit of gadofosveset. Reader agreement was good to excellent (gadobenate dimeglumine, kappa = 0.855; gadofosveset, kappa = 0.776). Reader preference was for gadobenate dimeglumine in 11, 17, and 13 patients and for gadofosveset in five, four, and five patients. No safety concerns were noted.


CONCLUSIONS
Better diagnostic performance and reader preference were found for gadobenate dimeglumine than gadofosveset in first-pass renal CE-MRA.
Schneider
Guenther
G
Department of Diagnostic and Interventional Radiology, University Hospital of Saarland, Homburg/Saar, Germany. guentherschneider@googlemail.com
Pasowicz
Mieczyslaw
M
Vymazal
Josef
J
Seidl
Zdenek
Z
Aschauer
Manuela
M
Konopka
Marek
M
Bilecen
Deniz
D
Iezzi
Roberto
R
Ballarati
Claudio
C
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003287:Contrast Media; D018592:Cross-Over Studies; D005060:Europe; D005260:Female; D005682:Gadolinium; D006801:Humans; D007089:Image Enhancement / Q000379:methods*; D018810:Magnetic Resonance Angiography / Q000379:methods*; D008297:Male; D008536:Meglumine / Q000031:analogs & derivatives*; D008875:Middle Aged; D009942:Organometallic Compounds; D012077:Renal Artery / Q000473:pathology*; D012078:Renal Artery Obstruction / Q000175:diagnosis*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
D003287:Contrast Media; D009942:Organometallic Compounds; C064572:gadobenic acid; D008536:Meglumine; D005682:Gadolinium; C109932:gadofosveset trisodium