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Evaluation of meglumine gadoterate-enhanced MR angiography (MRA) compared with time-of-flight MRA in the diagnosis of clinically significant non-coronary arterial disease: a pooled analysis of data from two clinical trials.

AbstractOBJECTIVES:
We analysed pooled data from two clinical trials to assess the diagnostic accuracy and safety of meglumine gadoterate (Gd-DOTA)-enhanced MR angiography (MRA) relative to those of non-enhanced time-of-flight (TOF) MRA for non-coronary arterial disease. Both techniques were compared with X-ray angiography as the gold standard.
METHODS:
Patients were of both sexes, were aged at least 18 years and had suspected non-coronary arterial disease. Each patient was his/her own control and underwent TOF MRA followed by Gd-DOTA-enhanced MRA, and then X-ray angiography. MRA was performed at 1.5 T (USA study) or 3 T (Republic of Korea study). The primary criterion used to evaluate efficacy was the degree to which the MRA examination agreed with X-ray angiography in assessing non-coronary arterial lesions. The performance of Gd-DOTA over TOF was assessed using a one-sided paired t-test. We also evaluated the specificity, sensitivity, image quality, examination duration and clinical safety of both MRA procedures.
RESULTS:
In total, 192 patients were enrolled and received Gd-DOTA. In the intent-to-treat population (n=162), within-patient accuracy was significantly greater for Gd-DOTA than for TOF (85.8 ± 19.8% agreement between Gd-DOTA and X-ray angiography compared with 78.3 ± 24.9% agreement between TOF and X-ray angiography; p=0.0001). The sensitivity, specificity, image quality and examination duration were also better for Gd-DOTA than for TOF. There were no serious drug-related adverse events.
CONCLUSION:
We conclude that Gd-DOTA-enhanced MRA is a safe and accurate procedure for detecting arterial stenosis at both 1.5 T and 3 T.
AuthorsD J Shah, T-H Lim
JournalThe British journal of radiology (Br J Radiol) Vol. 85 Issue 1013 Pg. 596-605 (May 2012) ISSN: 1748-880X [Electronic] England
PMID22167518 (Publication Type: Comparative Study, Journal Article, Research Support, Non-U.S. Gov't)
Chemical References
  • Contrast Media
  • Organometallic Compounds
  • Meglumine
  • gadoterate meglumine
Topics
  • Adult
  • Aged
  • Aged, 80 and over
  • Arteries
  • Clinical Trials as Topic
  • Contrast Media
  • Female
  • Humans
  • Magnetic Resonance Angiography (methods)
  • Male
  • Meglumine
  • Middle Aged
  • Organometallic Compounds
  • Radiography
  • Reproducibility of Results
  • Sensitivity and Specificity
  • Vascular Diseases (diagnosis, diagnostic imaging)
  • Young Adult

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