A multicenter, site-independent, blinded study to compare the diagnostic accuracy of contrast-enhanced magnetic resonance angiography using 1.0 M gadobutrol (Gadovist™) to intraarterial digital subtraction angiography in body arteries

Purpose: Prospective evaluation of diagnostic accuracy of single field-of-view contrast-enhanced MR Angiography (ceMRA) with 1.0M gadobutrol compared to intraarterial DSA in body arteries. Materials and methods: In an European multicenter study 179 patients underwent ceMRA and DSA. For each indication five prospectively defined vessel segments were evaluated by local investigators onsite and by three site-independent blinded readers (BR) independently. Results: The agreement between ceMRA and DSA diagnosis was statistically significant in the onsite (96.6%) and blinded reader (86.6-90.2%) evaluation. Sensitivity, specificity, accuracy, positive (PPV) and negative predictive values (NPV) for detection of relevant stenosis (> 50%) were calculated for the right and left internal carotid arteries, and common and external iliac arteries: Sensitivity was 95-98% (onsite) and 76-96% (BR), specificity 94-96% (onsite) and 86-94% (BR), accuracy 96% (onsite) and 87-93% (BR), NPV 98-99% (onsite) and 84-98% (BR), and PPV 79-93% (onsite) and 44-91 % (BR), respectively. Conclusion: CeMRA of body arteries using 1.0 M gadobutrol provides diagnostic information comparable to intraarterial DSA. (c) 2006 Elsevier Ireland Ltd. All rights reserved.