Renal artery stenosis evaluation: diagnostic performance of gadobenate dimeglumine-enhanced MR angiography--comparison with DSA.
OBJECTIVE
To prospectively determine diagnostic performance and safety of contrast material-enhanced (CE) magnetic resonance (MR) angiography with 0.1 mmol per kilogram of body weight gadobenate dimeglumine for depiction of significant steno-occlusive disease (> or =51% stenosis) of renal arteries, with digital subtraction angiography (DSA) as reference standard.


METHODS
This multicenter study was approved by local institutional review boards; all patients provided written informed consent. Patient enrollment and examination at centers in the United States complied with HIPAA. Two hundred ninety-three patients (154 men, 139 women; mean age, 61.0 years) with severe hypertension (82.2%), progressive renal failure (11.3%), and suspected renal artery stenosis (6.5%) underwent CE MR angiography with three-dimensional spoiled gradient-echo sequences after administration of 0.1 mmol/kg gadobenate dimeglumine at 2 mL/sec. Anteroposterior and oblique DSA was performed in 268 (91.5%) patients. Three independent blinded reviewers evaluated CE MR angiographic images. Sensitivity, specificity, and accuracy of CE MR angiography for detection of significant steno-occlusive disease (> or =51% vessel lumen narrowing) were determined at segment (main renal artery) and patient levels. Positive and negative predictive values and positive and negative likelihood ratios were determined. Interobserver agreement was analyzed with generalized kappa statistics. A safety evaluation (clinical examination, electrocardiogram, blood and urine analysis, monitoring for adverse events) was performed.


RESULTS
Of 268 patients, 178 who were evaluated with MR angiography and DSA had significant steno-occlusive disease of renal arteries at DSA. Sensitivity, specificity, and accuracy of CE MR angiography for detection of 51% or greater stenosis or occlusion were 60.1%-84.1%, 89.4%-94.7%, and 80.4%-86.9%, respectively, at segment level. Similar values were obtained for predictive values and for patient-level analyses. Few CE MR angiographic examinations (1.9%-2.8%) were technically inadequate. Interobserver agreement for detection of significant steno-occlusive disease was good (79.9% agreement; kappa = 0.69). No safety concerns were noted.


CONCLUSIONS
CE MR angiography performed with 0.1 mmol/kg gadobenate dimeglumine, compared with DSA, is safe and provides good sensitivity, specificity, and accuracy for detection of significant renal artery steno-occlusive disease.
Soulez
Gilles
G
Department of Radiology, Centre Hospitalier de l'Université de Montréal, University of Montreal, 1560 Sherbrooke East, Montreal, QC, Canada H2V 2Z2. gilles.soulez.chum@ssss.gouv.qc.ca
Pasowicz
Mieczyslaw
M
Benea
Giorgio
G
Grazioli
Luigi
L
Niedmann
Juan Pablo
JP
Konopka
Marek
M
Douek
Philippe C
PC
Morana
Giovanni
G
Schaefer
Fritz K W
FK
Vanzulli
Angelo
A
Bluemke
David A
DA
Maki
Jeffrey H
JH
Prince
Martin R
MR
Schneider
Günther
G
Ballarati
Claudio
C
Coulden
Richard
R
Wasser
Martin N
MN
McCauley
Thomas R
TR
Kirchin
Miles A
MA
Pirovano
Gianpaolo
G
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015901:Angiography, Digital Subtraction; D003287:Contrast Media; D005260:Female; D006801:Humans; D018810:Magnetic Resonance Angiography; D008297:Male; D008536:Meglumine / Q000031:analogs & derivatives*; D008875:Middle Aged; D009942:Organometallic Compounds; D011237:Predictive Value of Tests; D012077:Renal Artery / Q000000981:diagnostic imaging / Q000473:pathology; D012078:Renal Artery Obstruction / Q000175:diagnosis* / Q000000981:diagnostic imaging; D012680:Sensitivity and Specificity
D003287:Contrast Media; D009942:Organometallic Compounds; C064572:gadobenic acid; D008536:Meglumine