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


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 alpha = 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.


CONCLUSIONS
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.
Garovic
Vesna D
VD
Department of Medicine, Mayo Clinic, Rochester, Minnesota, USA. garovic.vesna@mayo.edu
Achauer
Manuela A
MA
Kittner
Thomas
T
Horák
David
D
Sheng
Rubin
R
Stanson
Anthony W
AW
D015901:Angiography, Digital Subtraction / Q000379:methods*; D003287:Contrast Media; D005260:Female; D019786:Gadolinium DTPA; D006801:Humans; D007089:Image Enhancement / Q000379:methods*; D038622:Internationality; D018810:Magnetic Resonance Angiography / Q000379:methods*; D008297:Male; D008954:Models, Biological; D012078:Renal Artery Obstruction / Q000175:diagnosis*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
D003287:Contrast Media; C064925:gadodiamide; D019786:Gadolinium DTPA