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

Author(s): Iezzi R, Soulez G, Thurnher S, Schneider G, Kirchin MA, Shen N, Pirovano G, Spinazzi A

Affiliation(s): Department of Radiology, Universita G D'Annunzio, Chieti, Italy.

Publication date & source: 2011-02, Eur J Radiol., 77(2):358-68. Epub 2009 Aug 12.

Publication type: Clinical Trial, Phase III; Comparative Study

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((R))) and gadofosveset trisodium (Vasovist(R))) 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. Copyright (c) 2009 Elsevier Ireland Ltd. All rights reserved.

Page last updated: 2011-12-09

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