title: 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.
abstract: 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.
authors.affiliation: Department of Diagnostic Radiology, University Hospital Schleswig-Holstein Campus Kiel, Arnold-Heller-Strasse 9, 24105 Kiel, Germany. fschaefer@email.uni-kiel.de
authors.forename: Fritz K W
authors.initials: FK
authors.lastname: Schaefer
authors.forename: Philipp J
authors.initials: PJ
authors.lastname: Schaefer
authors.forename: Christian
authors.initials: C
authors.lastname: Altjohann
authors.forename: Michael
authors.initials: M
authors.lastname: Bourne
authors.forename: Francesco
authors.initials: F
authors.lastname: Decobelli
authors.forename: Mathias
authors.initials: M
authors.lastname: Goyen
authors.forename: Paul D
authors.initials: PD
authors.lastname: Griffiths
authors.forename: Lars
authors.initials: L
authors.lastname: Kopka
authors.forename: Karl F
authors.initials: KF
authors.lastname: Kreitner
authors.forename: Johann
authors.initials: J
authors.lastname: Link
authors.forename: Katja
authors.initials: K
authors.lastname: Oberholzer
authors.forename: Christiane
authors.initials: C
authors.lastname: Pering
authors.forename: Christiane
authors.initials: C
authors.lastname: Poeckler-Schoeninger
authors.forename: Stefan G
authors.initials: SG
authors.lastname: Ruehm
authors.forename: Mansur R
authors.initials: MR
authors.lastname: Sachoran
authors.forename: Gernot
authors.initials: G
authors.lastname: Schulte-Altedorneburg
authors.forename: Oliver S
authors.initials: OS
authors.lastname: Springer
authors.forename: Paul
authors.initials: P
authors.lastname: Steiner
authors.forename: Alexander
authors.initials: A
authors.lastname: Wall
authors.forename: Jan
authors.initials: J
authors.lastname: Winterer
authors.forename: Bernd
authors.initials: B
authors.lastname: Tombach
mesh_terms: 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
chemical_list: D003287:Contrast Media; D009942:Organometallic Compounds; C090600:gadobutrol; D005682:Gadolinium