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.
OBJECTIVE
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.


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.


CONCLUSIONS
CeMRA of body arteries using 1.0M gadobutrol provides diagnostic information comparable to intraarterial DSA.
Schaefer
Fritz K W
FK
Department of Diagnostic Radiology, University Hospital Schleswig-Holstein Campus Kiel, Arnold-Heller-Strasse 9, 24105 Kiel, Germany. fschaefer@email.uni-kiel.de
Schaefer
Philipp J
PJ
Altjohann
Christian
C
Bourne
Michael
M
Decobelli
Francesco
F
Goyen
Mathias
M
Griffiths
Paul D
PD
Kopka
Lars
L
Kreitner
Karl F
KF
Link
Johann
J
Oberholzer
Katja
K
Pering
Christiane
C
Poeckler-Schoeninger
Christiane
C
Ruehm
Stefan G
SG
Sachoran
Mansur R
MR
Schulte-Altedorneburg
Gernot
G
Springer
Oliver S
OS
Steiner
Paul
P
Wall
Alexander
A
Winterer
Jan
J
Tombach
Bernd
B
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015901:Angiography, Digital Subtraction; D001158:Arteries / Q000473:pathology*; D003251:Constriction, Pathologic / Q000175:diagnosis; D003287:Contrast Media; D005682:Gadolinium; D006801:Humans; D018810:Magnetic Resonance Angiography / Q000379:methods*; D008297:Male; D008875:Middle Aged; D009942:Organometallic Compounds; D011446:Prospective Studies; D012680:Sensitivity and Specificity; D016037:Single-Blind Method
D003287:Contrast Media; D009942:Organometallic Compounds; C090600:gadobutrol; D005682:Gadolinium