Roberto IEZZI et al. (2011) Contrast-enhanced MRA of the renal and aorto-iliac-femoral arteries: Comparison of gadobenate dimeglumine and gadofosveset trisodium

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Contrast-enhanced MRA of the renal and aorto-iliac-femoral arteries: Comparison of gadobenate dimeglumine and gadofosveset trisodium

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CONTRIBUTORS:

	Author:	Roberto IEZZI
	Author:	Gilles SOULEZ
	Author:	Siegfried THURNHER
	Author:	Gunther SCHNEIDER
	Author:	Miles A. KIRCHIN
	Author:	Ningyan SHEN
	Author:	Gianpaolo PIROVANO
	Author:	Alberto SPINAZZI

JOURNAL:

European journal of radiology, 77(2), 358 - 368.

YEAR:

2011

PUB TYPE:

Journal Article

SUBJECT(S):

medicine - radiology

DISCIPLINE:

Medicine

HTTP:

http://dx.doi.org/10.1016/j.ejrad.2009.07.020

LANGUAGE:

English

PUB ID:

103-486-666 (Last edited on 2011/04/17 05:57:45 GMT-6)

SPONSOR(S):

ABSTRACT:
Rationale and objectives 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. Materials and 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. Conclusion 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.

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