Contrast-enhanced MRA of the renal and aorto-iliac-femoral arteries: comparison of gadobenate dimeglumine and gadofosveset trisodium.
OBJECTIVE
Dedicated contrast agents are now available for contrast-enhanced magnetic resonance angiography (CE-MRA). This study retrospectively compares the safety and diagnostic performance data from Phase III regulatory trials performed to evaluate gadobenate dimeglumine (MultiHance(®)) and gadofosveset trisodium (Vasovist®)) for renal and peripheral CE-MRA.


METHODS
Similar examination and blinded assessment methodology was utilized in all studies to determine the safety and diagnostic performance of the agents for detection of significant (>50%) steno-occlusive disease. Digital Subtraction Angiography (DSA) was used as the standard of truth. Diagnostic performance data (sensitivity, specificity, predictive values [PVs], and likelihood ratios [LRs]) were compared (Chi-square test).


RESULTS
CE-MRA with gadobenate dimeglumine was more specific (92.4% vs. 80.5%, p < 0.0001) and accurate (83.6% vs. 77.1%, p = 0.022) than CE-MRA with gadofosveset in the detection of significant renal artery stenosis. The average sensitivity was higher for gadofosveset (74.4% vs. 67.3%, p = 0.011) in peripheral vessels although gadobenate dimeglumine was more specific (93.0% vs. 88.2%, p < 0.0001) with no difference in accuracy (86.6% vs. 86.3%, p = 0.66). PPVs were higher (p < 0.0001) for gadobenate dimeglumine in both vascular territories. Pre- to post-test shifts in the probability of detecting significant disease were greater after gadobenate dimeglumine. Adverse events in the renal and peripheral studies were reported by 9.2% and 7.7% of patients after gadobenate dimeglumine compared with 30.3% and 22.1% of patients after gadofosveset.


CONCLUSIONS
The diagnostic performance of CE-MRA for the detection of significant steno-occlusive disease is similar with gadofosveset and gadobenate dimeglumine although the rate of adverse events appears higher with gadofosveset.
Iezzi
Roberto
R
Department of Radiology, Università G D'Annunzio, Chieti, Italy.
Soulez
Gilles
G
Thurnher
Siegfried
S
Schneider
Günther
G
Kirchin
Miles A
MA
Shen
Ningyan
N
Pirovano
Gianpaolo
G
Spinazzi
Alberto
A
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003287:Contrast Media; D005260:Female; D005682:Gadolinium; D006801:Humans; D007089:Image Enhancement / Q000379:methods*; D008279:Magnetic Resonance Imaging / Q000379:methods*; D008297:Male; D008536:Meglumine / Q000031:analogs & derivatives*; D008875:Middle Aged; D009942:Organometallic Compounds; D058729:Peripheral Arterial Disease / Q000473:pathology*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D055815:Young Adult
D003287:Contrast Media; D009942:Organometallic Compounds; C064572:gadobenic acid; D008536:Meglumine; D005682:Gadolinium; C109932:gadofosveset trisodium