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Comparative Study
. 2007 Feb;61(2):315-23.
doi: 10.1016/j.ejrad.2006.09.002. Epub 2006 Oct 30.

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

Fritz K W Schaefer  1 , Philipp J Schaefer, Christian Altjohann, Michael Bourne, Francesco Decobelli, Mathias Goyen, Paul D Griffiths, Lars Kopka, Karl F Kreitner, Johann Link, Katja Oberholzer, Christiane Pering, Christiane Poeckler-Schoeninger, Stefan G Ruehm, Mansur R Sachoran, Gernot Schulte-Altedorneburg, Oliver S Springer, Paul Steiner, Alexander Wall, Jan Winterer, Bernd Tombach
Affiliations
Comparative Study

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

Fritz K W Schaefer et al. Eur J Radiol. 2007 Feb.

Abstract

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 1.0M gadobutrol provides diagnostic information comparable to intraarterial DSA.

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