| Gadobenate dimeglumine and gadofosveset trisodium for MR angiography of the renal arteries: Multicenter intraindividual crossover comparison. | |
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MedLine Citation:
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PMID: 20651208 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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. SUBJECTS AND 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. CONCLUSION: Better diagnostic performance and reader preference were found for gadobenate dimeglumine than gadofosveset in first-pass renal CE-MRA. |
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Authors:
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Guenther Schneider; Mieczyslaw Pasowicz; Josef Vymazal; Zdenek Seidl; Manuela Aschauer; Marek Konopka; Deniz Bilecen; Roberto Iezzi; Claudio Ballarati |
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Publication Detail:
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Type: Clinical Trial; Comparative Study; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: AJR. American journal of roentgenology Volume: 195 ISSN: 1546-3141 ISO Abbreviation: AJR Am J Roentgenol Publication Date: 2010 Aug |
Date Detail:
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Created Date: 2010-07-23 Completed Date: 2010-09-24 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 7708173 Medline TA: AJR Am J Roentgenol Country: United States |
Other Details:
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Languages: eng Pagination: 476-85 Citation Subset: AIM; IM |
Affiliation:
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Department of Diagnostic and Interventional Radiology, University Hospital of Saarland, Homburg/Saar, Germany. guentherschneider@googlemail.com |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Adult Aged Aged, 80 and over Contrast Media Cross-Over Studies Europe Female Gadolinium / diagnostic use* Humans Image Enhancement / methods* Magnetic Resonance Angiography / methods* Male Meglumine / analogs & derivatives*, diagnostic use Middle Aged Organometallic Compounds / diagnostic use* Renal Artery / pathology* Renal Artery Obstruction / diagnosis* Reproducibility of Results Sensitivity and Specificity |
| Chemical | |
Reg. No./Substance:
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0/Contrast Media; 0/Organometallic Compounds; 0/gadofosveset trisodium; 113662-23-0/gadobenic acid; 6284-40-8/Meglumine; 7440-54-2/Gadolinium |
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