Renal Artery Stenosis Evaluation: Diagnostic Performance of Gadobenate Dimeglumine-enhanced MR Angiography--Comparison with DSA

doi:10.1148/radiol.2471070711

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Vascular and Interventional Radiology

Renal Artery Stenosis Evaluation: Diagnostic Performance of Gadobenate Dimeglumine–enhanced MR Angiography—Comparison with DSA¹

Gilles Soulez, MD, MSc, Mieczyslaw Pasowicz, MD, Giorgio Benea, MD, Luigi Grazioli, MD, Juan Pablo Niedmann, MD, Marek Konopka, MD, Philippe C. Douek, MD, Giovanni Morana, MD, Fritz K. W. Schaefer, MD, Angelo Vanzulli, MD, David A. Bluemke, MD, Jeffrey H. Maki, MD, Martin R. Prince, MD, PhD, Günther Schneider, MD, PhD, Claudio Ballarati, MD, Richard Coulden, MD, Martin N. Wasser, MD, Thomas R. McCauley, MD, Miles A. Kirchin, PhD, and Gianpaolo Pirovano, MD

¹ From the Department of Radiology, Centre Hospitalier de l'Université de Montréal, University of Montreal, 1560 Sherbrooke East, Montreal, QC, Canada H2V 2Z2 (G. Soulez). The complete list of author affiliations and enrolling centers is at the end of this article. From the 2006 RSNA Annual Meeting. Received April 21, 2007; revision requested June 11; revision received July 20; accepted August 17; final version accepted September 26. Supported by Bracco Diagnostics and by research scholarships from the Fonds de la Recherche en Santé du Québec (G. Soulez). Address correspondence to G. Soulez (e-mail: gilles.soulez.chum{at}ssss.gouv.qc.ca).

Purpose: To prospectively determine diagnostic performance and safetyof contrast material–enhanced (CE) magnetic resonance (MR)angiography with 0.1 mmol per kilogram of body weight gadobenatedimeglumine for depiction of significant steno-occlusive disease( $≥$ 51% stenosis) of renal arteries, with digital subtraction angiography(DSA) as reference standard.

Materials and Methods: This multicenter study was approved by localinstitutional review boards; all patients provided written informedconsent. Patient enrollment and examination at centers in the UnitedStates complied with HIPAA. Two hundred ninety-three patients (154men, 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 spoiledgradient-echo sequences after administration of 0.1 mmol/kg gadobenatedimeglumine at 2 mL/sec. Anteroposterior and oblique DSA was performedin 268 (91.5%) patients. Three independent blinded reviewers evaluatedCE MR angiographic images. Sensitivity, specificity, and accuracyof CE MR angiography for detection of significant steno-occlusivedisease ( $≥$ 51% vessel lumen narrowing) were determined at segment (mainrenal artery) and patient levels. Positive and negative predictivevalues and positive and negative likelihood ratios were determined.Interobserver agreement was analyzed with generalized ${kappa}$ statistics.A safety evaluation (clinical examination, electrocardiogram, bloodand urine analysis, monitoring for adverse events) was performed.

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

Conclusion: CE MR angiography performed with 0.1 mmol/kg gadobenatedimeglumine, compared with DSA, is safe and provides good sensitivity,specificity, and accuracy for detection of significant renal arterysteno-occlusive disease.