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Diagnostic Performance of Gadobenate Dimeglumine–Enhanced MR Angiography of the Iliofemoral and Calf Arteries: A Large-Scale Multicenter Trial

¹ Department of Radiology and Nuclear Medicine, Hospital Brothers of St. John of God, Grosse Mohrengasse 9, Vienna, Austria A-1020.
² Department of Diagnostic Radiology, Eberhardt Karls University, Tuebingen, Germany.
³ Department of Diagnostic Radiology, Homburg University Hospital, Homburg/Saar, Germany.
⁴ Department of Radiology, Hospital Valduce, Como, Italy.
⁵ Institute for Diagnostic Radiology, University Hospital, Basel, Switzerland.
⁶ Medical Prevention Center, University Mxedical Center, Hamburg-Eppendorf, Germany.
⁷ Institute of Clinical Radiology, Ludwig Maximilians University, Munich, Germany.
⁸ U.C.O. di Radiologia, Ospedale di Cattinara, Trieste, Italy.
⁹ Department of Radiology, Ospedale Cà Foncello, Treviso, Italy.
¹⁰ Crawford Long Hospital, Atlanta, GA.
¹¹ Department of Radiology, Università G. D'Annunzio, Chieti, Italy.
¹² Institut für Radiologie, Charité-Universitäts medizin, Berlin, Germany.
¹³ Department of Radiology, Johns Hopkins Medical Center, Baltimore, MD.
¹⁴ Klinikum der Johannes, Gutenberg Universität, Mainz, Germany.
¹⁵ Worldwide Medical and Regulatory Affairs, Bracco Imaging SpA, Milan, Italy.
¹⁶ Worldwide Medical and Regulatory Affairs, Bracco Diagnostics Inc., Princeton, NJ.

OBJECTIVE. The purpose of this study was to compare gadobenate dimeglumine–enhanced MR angiography and unenhanced time-of-flight MR angiography for the detection of significant peripheral arterial occlusive disease using digital subtraction angiography as our reference standard.

SUBJECTS AND METHODS. Two hundred seventy-two patients underwent MR angiography and digital subtraction angiography of the iliofemoral arteries. MR angiography was performed before (2D time-of-flight acquisitions) and after (spoiled gradient-echo acquisitions) the administration of 0.1 mmol/kg of gadobenate dimeglumine at 1–2 mL/s. Contrast-enhanced MR angiography and digital subtraction angiography of the calf arteries were performed in 241 of 272 participants. Images were evaluated on-site and by four blinded reviewers (three for MR angiography, one for digital subtraction angiography). Comparative diagnostic performance for the detection of significant ( 51% vessel lumen narrowing) disease was evaluated using the McNemar test and generalized estimating equations. Interobserver agreement was assessed with generalized kappa statistics. The chi-square test was used to compare technical failure rates.

RESULTS. Digital subtraction angiography confirmed significant disease (597 stenoses, 386 occlusions) in 983 iliofemoral segments. The sensitivity (54–80.9%), specificity (89.7–95.3%), and accuracy (85–87.5%) of contrast-enhanced MR angiography for the detection of significant iliofemoral disease were significantly (p < 0.001, all reviewers) better than those of time-of-flight MR angiography (33.2–62.8%, 74.3–88.9%, and 68–77.3%, respectively). Similar diagnostic performance was obtained for the calf arteries. The technical failure rate with contrast-enhanced MR angiography (2.5–3.4%) was similar to that of digital subtraction angiography (1.4%) and significantly (p < 0.001) lower than that of time-of-flight MR angiography (6.2–18.0%). Significantly better reproducibility (p < 0.001) was obtained with contrast-enhanced MR angiography (82% vs 65.2% agreement; = 0.66 vs 0.45).

CONCLUSION. Improved diagnostic performance and reproducibility are achievable with gadobenate dimeglumine–enhanced MR angiography in patients with peripheral arterial occlusive disease.

Keywords: contrast agents • diagnostic performance • gadobenate dimeglumine • MR angiography • peripheral arterial occlusive disease

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