Multicenter, double-blind, randomized, intraindividual crossover comparison of gadobenate dimeglumine and gadopentetate dimeglumine for MR angiography of peripheral arteries.
OBJECTIVE
To prospectively compare the image quality and diagnostic performance achieved with doses of gadobenate dimeglumine and gadopentetate dimeglumine of 0.1 mmol per kilogram of body weight in patients undergoing contrast material-enhanced magnetic resonance (MR) angiography of the pelvis, thigh, and lower-leg (excluding foot) for suspected or known peripheral arterial occlusive disease.


METHODS
Institutional review board approval was granted from each center and informed written consent was obtained from all patients. Between November 2006 and January 2008, 96 patients (62 men, 34 women; mean age, 63.7 years +/- 10.4 [standard deviation]; range, 39-86 years) underwent two identical examinations at 1.5 T by using three-dimensional spoiled gradient-echo sequences and randomized 0.1-mmol/kg doses of each agent. Images were evaluated on-site for technical adequacy and quality of vessel visualization and offsite by three independent blinded readers for anatomic delineation and detection/exclusion of pathologic features. Comparative diagnostic performance was determined in 31 patients who underwent digital subtraction angiography. Data were analyzed by using the Wilcoxon signed-rank, McNemar, and Wald tests. Interreader agreement was determined by using generalized kappa statistics. Differences in quantitative contrast enhancement were assessed and a safety evaluation was performed.


RESULTS
Ninety-two patients received both agents. Significantly better performance (P < .0001; all evaluations) with gadobenate dimeglumine was noted on-site for technical adequacy and vessel visualization quality and offsite for anatomic delineation and detection/exclusion of pathologic features. Contrast enhancement (P < or = .0001) and detection of clinically relevant disease (P < or = .0028) were significantly improved with gadobenate dimeglumine. Interreader agreement for stenosis detection and grading was good to excellent (kappa = 0.749 and 0.805, respectively). Mild adverse events were reported for four (six events) and five (eight events) patients after gadobenate dimeglumine and gadopentetate dimeglumine, respectively.


CONCLUSIONS
Higher-quality vessel visualization, greater contrast enhancement, fewer technical failures, and improved diagnostic performance are obtained with gadobenate dimeglumine, relative to gadopentetate dimeglumine, when compared intraindividually at 0.1-mmol/kg doses in patients undergoing contrast-enhanced MR angiography for suspected peripheral arterial occlusive disease.
Gerretsen
Suzanne C
SC
Dept of Cardiovascular MR Research, Maastricht Univ Hosp, Peter Debijelaan 25, 6229HX Maastricht, the Netherlands.
le Maire
Thierry F
TF
Miller
Stephan
S
Thurnher
Siegfried A
SA
Herborn
Christoph U
CU
Michaely
Henrik J
HJ
Kramer
Harald
H
Vanzulli
Angelo
A
Vymazal
Josef
J
Wasser
Martin N
MN
Ballarati
Claudio E M
CE
Kirchin
Miles A
MA
Pirovano
Gianpaolo
G
Leiner
Tim
T
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003287:Contrast Media; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D019786:Gadolinium DTPA; D006801:Humans; D035002:Lower Extremity / Q000098:blood supply; D018810:Magnetic Resonance Angiography / Q000379:methods*; D008297:Male; D008536:Meglumine / Q000031:analogs & derivatives*; D008875:Middle Aged; D009942:Organometallic Compounds; D010388:Pelvis / Q000098:blood supply; D016491:Peripheral Vascular Diseases / Q000175:diagnosis*; D011446:Prospective Studies; D018709:Statistics, Nonparametric
D003287:Contrast Media; D009942:Organometallic Compounds; C064572:gadobenic acid; D008536:Meglumine; D019786:Gadolinium DTPA