title: 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.
abstract: OBJECTIVE
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Cardiac Magnetic Resonance Imaging, Weill Cornell Medical College, The Methodist DeBakey Heart and Vascular Center, Houston, TX, USA.
authors.forename: D J
authors.initials: DJ
authors.lastname: Shah
authors.forename: T-H
authors.initials: TH
authors.lastname: Lim
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001158:Arteries; D002986:Clinical Trials as Topic; D003287:Contrast Media; D005260:Female; D006801:Humans; D018810:Magnetic Resonance Angiography / Q000379:methods*; D008297:Male; D008536:Meglumine; D008875:Middle Aged; D009942:Organometallic Compounds; D011859:Radiography; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D014652:Vascular Diseases / Q000175:diagnosis* / Q000000981:diagnostic imaging; D055815:Young Adult
chemical_list: D003287:Contrast Media; D009942:Organometallic Compounds; D008536:Meglumine; C072417:gadoterate meglumine