Comparison of gadodiamide-enhanced MR angiography to intraarterial digital subtraction angiography for evaluation of renal artery stenosis: Results of a phase III multicenter trial

• Published in: Journal of magnetic resonance imaging Vol. 31; no. 2; pp. 390 - 397
• Main Authors: Garovic, Vesna D., Achauer, Manuela A., Kittner, Thomas, Horák, David, Sheng, Rubin, Stanson, Anthony W.
• Format: Journal Article
• Language: English
• Published: Hoboken Wiley Subscription Services, Inc., A Wiley Company 01.02.2010
• Subjects: Angiography, Digital Subtraction - methods; Contrast Media; contrast-enhanced magnetic resonance angiography; controlled study; Female; gadodiamide administration; Gadolinium DTPA; Humans; Image Enhancement - methods; Internationality; Magnetic Resonance Angiography - methods; Male; Models, Biological; multicenter; multicenter, controlled study; Renal Artery Obstruction - diagnosis; renal artery stenosis; Reproducibility of Results; Sensitivity and Specificity
• ISSN: 1053-1807; 1522-2586
• DOI: 10.1002/jmri.22032

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.