Original Research

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

  1. Vesna D. Garovic MD1,*,
  2. Manuela A. Achauer MD2,
  3. Thomas Kittner MD3,
  4. David Horák MD4,
  5. Rubin Sheng MD, MPH5,
  6. Anthony W. Stanson MD6

Article first published online: 23 JAN 2010

DOI: 10.1002/jmri.22032

Issue

Journal of Magnetic Resonance Imaging

Journal of Magnetic Resonance Imaging

Volume 31, Issue 2, pages 390–397, February 2010

Additional Information

How to Cite

Garovic, V. D., Achauer, M. A., Kittner, T., Horák, D., Sheng, R. and Stanson, A. W. (2010), Comparison of gadodiamide-enhanced MR angiography to intraarterial digital subtraction angiography for evaluation of renal artery stenosis: Results of a phase III multicenter trial. J. Magn. Reson. Imaging, 31: 390–397. doi: 10.1002/jmri.22032

Author Information

  1. 1

    Division of Nephrology and Hypertension, Department of Medicine, Mayo Clinic, Rochester, Minnesota, USA

  2. 2

    Vascular and Interventional Radiology Clinic, Graz, Austria

  3. 3

    Radiology Clinic, Dresden Hospital, Dresden, Germany

  4. 4

    RDG FN Olomouc, I. P. Pavlova 6, Czech Republic

  5. 5

    Clinical R&D, Medical Diagnostics, GE Healthcare, Princeton, New Jersey, USA

  6. 6

    Department of Radiology, Mayo Clinic, Rochester, Minnesota, USA

*Division of Nephrology and Hypertension, Mayo Clinic, 200 First Street SW, Rochester, MN 55905

Publication History

  1. Issue published online: 23 JAN 2010
  2. Article first published online: 23 JAN 2010
  3. Manuscript Accepted: 28 OCT 2009
  4. Manuscript Received: 26 MAY 2009

Funded by

  • GE Healthcare, Inc.
  • Medical Diagnostics, Princeton, NJ

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Keywords:

  • contrast-enhanced magnetic resonance angiography;
  • renal artery stenosis;
  • multicenter, controlled study;
  • gadodiamide administration

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.

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