Abstract | OBJECTIVES: 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.
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Authors | D J Shah, T-H Lim |
Journal | The British journal of radiology
(Br J Radiol)
Vol. 85
Issue 1013
Pg. 596-605
(May 2012)
ISSN: 1748-880X [Electronic] England |
PMID | 22167518
(Publication Type: Comparative Study, Journal Article, Research Support, Non-U.S. Gov't)
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Chemical References |
- Contrast Media
- Organometallic Compounds
- Meglumine
- gadoterate meglumine
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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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