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

Abstract Purpose Prospective evaluation of diagnostic accuracy of single field-of-view contrast-enhanced MR Angiography (ceMRA) with 1.0 M 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.