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

Objectives: We analysed pooled data from two clinical trials to assess the diagnostic accuracy and safety ofmeglumine gadoterate (Gd-DOTA)-enhancedMR 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 intentto- 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.