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Safety and Effectiveness of Single- versus Triple-Dose Gadodiamide Injection- enhanced MR Angiography of the Abdomen: A Phase III Double-Blind Multicenter Study¹

¹ From the Depts of Radiology of Univ Hosp, Währinger Gürtel 18–20, A-1093 Vienna, Austria (S.A.T., C.L.); Osatek Hosp de Galdácano, Spain (A.C.); Hosp Ruber Internacional, Madrid, Spain (F.H.D.O.); Centre Hosp Univ, Liège, Belgium (R.F.D.); Donostia-San Sebastián, Spain (C.G.); Martin Luther Univ, Halle, Germany (A.G.J.); Univ Central Hosp, Helsinki, Finland (P.K.); Univ Hosp, Nottingham, United Kingdom (C.N.L.); Nycomed Amersham Imaging, Munich, Germany (M.M.); Hosp Univ Dr Peset, Valencia, Spain (J.P.d.C., L.M.B.); Centre Hosp Régional, Univ de Lille, France (J.P.P.); Hosp General Univ, Valencia (V.M.S.); and Univ Hosp Rudolf Virchow, Berlin, Germany (T.V.). Supported by Nycomed Amersham. Received Jan 4, 2000; revision requested Feb 28; final revision received Aug 21; accepted Sep 14. Address correspondence to S.A.T. (e-mail: siegfried.thurnher@univie.ac.at).

PURPOSE: To evaluate the safety and effectiveness of gadodiamide-enhanced magnetic resonance (MR) angiography with single and triple doses in the assessment of abdominal arterial stenoses.

MATERIALS AND METHODS: One hundred five patients were included in the randomized, double-blind, phase III multicenter trial. Results of MR angiography with 0.1 mmol/kg and 0.3 mmol/kg doses of gadodiamide were compared with those of digital subtraction angiography (DSA) and according to dose.

RESULTS: No serious adverse events were observed. The mean contrast index at the region proximal to the primary stenosis was significantly higher in the triple-dose group (P = .03). Mean 95% CI values for the difference in depicted degree of stenosis between DSA and postcontrast MR angiography improved from -3.4% ± 4.7 (SD) in the single-dose group to -1.2% ± 4.7 in the triple-dose group. Mean values for overall image quality on the visual analogue scale improved with the triple dose (P = .02). Confidence in diagnosis was high at postcontrast MR angiography in 88% and 96% of cases in the single- and triple-dose groups, respectively.

CONCLUSION: Gadodiamide-enhanced MR angiography performed with single and triple doses is safe and effective for assessing major abdominal arterial stenoses. Although high agreement between MR angiography and DSA was achieved with both doses, triple-dose MR angiography was superior in the evaluations of image quality, degree of arterial stenoses, and confidence in diagnosis.

Index terms: Arteries, stenosis or obstruction, 95.72, 96.72, 98.72 • Contrast media • Gadolinium • Magnetic resonance (MR), vascular studies, 95.12942, 95.12943, 96.12942, 96.12943, 98.12942, 98.12943

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