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Comparison of gadodiamide‐enhanced MR angiography to intraarterial digital subtraction angiography for evaluation of renal artery stenosis: Results of a phase III multicenter trial
Author(s) -
Garovic Vesna D.,
Achauer Manuela A.,
Kittner Thomas,
Horák David,
Sheng Rubin,
Stanson Anthony W.
Publication year - 2010
Publication title -
journal of magnetic resonance imaging
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.563
H-Index - 160
eISSN - 1522-2586
pISSN - 1053-1807
DOI - 10.1002/jmri.22032
Subject(s) - gadodiamide , medicine , nephrogenic systemic fibrosis , digital subtraction angiography , radiology , renal artery stenosis , magnetic resonance angiography , stenosis , gold standard (test) , angiography , magnetic resonance imaging , population , nuclear medicine , renal artery , kidney , environmental health
Abstract Purpose: To evaluate the efficacy and safety of 0.1 mmol/kg gadodiamide administration for contrast‐enhanced magnetic resonance angiography (MRA) in detecting hemodynamically relevant renal artery stenosis (RAS) when compared with intraarterial digital subtraction angiography (IA‐DSA) as the gold standard. Materials and Methods: In a multicenter, controlled study, 395 patients with suspected or known RAS were included. Three independent readers evaluated the MRA images. Two readers evaluated the IA‐DSA images and subsequently achieved consensus. The sensitivities and specificities of gadodiamide‐enhanced MRA were analyzed at the per‐patient and per‐vessel levels (exact 1‐sided binomial test at α = 0.025 with 95% confidence interval). Results: A total of 335 patients who had available standard of truth and MRA tests were included in the all‐subjects efficacy population: 55.5% (186/335) men and 44.5% women with a mean age of 63 ± 13 years (range 17–85 years). The sensitivities and specificities ranged from 81% to 86% for all independent readers at the per‐patient analysis based on subjects with the diagnostic images. Similar results were achieved with per‐vessel level analysis. Fewer than 1% of patients had adverse event associated with gadodiamide administration. There were no cases of nephrogenic systemic fibrosis (NSF) reported. Conclusion: Gadodiamide administration at the labeled dose of 0.1 mmol/kg for contrast‐enhanced MRA achieved equivalent results compared to IA‐DSA in evaluation of RAS and was well tolerated. J. Magn. Reson. Imaging 2010; 31: 390–397. © 2010 Wiley‐Liss, Inc.