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

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 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.

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.

• Authors: Vesna D Garovic, Manuela A Achauer, Thomas Kittner, David Horák, Rubin Sheng, Anthony W Stanson
• Journal: Journal of magnetic resonance imaging : JMRI (J Magn Reson Imaging) Vol. 31 Issue 2 Pg. 390-7 (Feb 2010) ISSN: 1522-2586 [Electronic] United States
• PMID: 20099352 (Publication Type: Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Contrast Media
• gadodiamide
• Gadolinium DTPA

Topics

• Angiography, Digital Subtraction (methods)
• Contrast Media
• Female
• Gadolinium DTPA
• Humans
• Image Enhancement (methods)
• Internationality
• Magnetic Resonance Angiography (methods)
• Male
• Models, Biological
• Renal Artery Obstruction (diagnosis)
• Reproducibility of Results
• Sensitivity and Specificity