Multicenter, Double-Blind, Randomized, Intraindividual Crossover Comparison of Gadobenate Dimeglumine and Gadopentetate Dimeglumine for MR Angiography of Peripheral Arteries

被引:44
作者
Gerretsen, Suzanne C. [1 ]
le Maire, Thierry F. [2 ]
Miller, Stephan [3 ]
Thurnher, Siegfried A. [4 ]
Herborn, Christoph U. [5 ]
Michaely, Henrik J. [6 ]
Kramer, Harald [7 ]
Vanzulli, Angelo [8 ]
Vymazal, Josef [9 ]
Wasser, Martin N. [10 ]
Ballarati, Claudio E. M. [11 ]
Kirchin, Miles A. [12 ]
Pirovano, Gianpaolo [13 ]
Leiner, Tim [1 ]
机构
[1] Maastricht Univ Hosp, Dept Cardiovasc MR Res, NL-6229 HX Maastricht, Netherlands
[2] Reinier De Graaf Hosp, Dept Radiol, Delft, Netherlands
[3] Univ Tubingen, Dept Diagnost & Intervent Radiol, Tubingen, Germany
[4] Hosp St John God, Dept Radiol, Vienna, Austria
[5] Univ Med Ctr Hamburg Eppendorf, Med Prevent Ctr, Hamburg, Germany
[6] Univ Med Ctr Mannheim, Inst Clin Radiol & Nucl Med, Mannheim, Germany
[7] Univ Munich, Inst Clin Radiol, Munich, Germany
[8] Osped Niguarda Ca Granda, Dept Radiol, Milan, Italy
[9] Homolce Hosp, Dept Radiol, Prague, Czech Republic
[10] Leiden Univ, Med Ctr, Dept Radiol, Leiden, Netherlands
[11] Hosp Valduce, Dept Radiol, Como, Italy
[12] Bracco Imaging, Dept Worldwide Med & Regulatory Affairs, Milan, Italy
[13] Bracco Diagnost, Dept Worldwide Med & Regulatory Affairs, Princeton, NJ USA
关键词
MAGNETIC-RESONANCE ANGIOGRAPHY; DIGITAL-SUBTRACTION-ANGIOGRAPHY; NEPHROGENIC SYSTEMIC FIBROSIS; AORTOILIAC OCCLUSIVE DISEASE; DOSE GADODIAMIDE INJECTION; DIAGNOSTIC PERFORMANCE; CONTRAST AGENTS; RENAL-ARTERIES; PHASE-III; TESLA;
D O I
10.1148/radiol.10090357
中图分类号
R8 [特种医学]; R445 [影像诊断学];
学科分类号
1002 ; 100207 ; 1009 ;
摘要
Purpose: To prospectively compare the image quality and diagnostic performance achieved with doses of gadobenate dimeglumine and gadopentetate dimeglumine of 0.1 mmol per kilogram of body weight in patients undergoing contrast material-enhanced magnetic resonance (MR) angiography of the pelvis, thigh, and lower-leg (excluding foot) for suspected or known peripheral arterial occlusive disease. Materials and Methods: Institutional review board approval was granted from each center and informed written consent was obtained from all patients. Between November 2006 and January 2008, 96 patients (62 men, 34 women; mean age, 63.7 years +/- 10.4 [standard deviation]; range, 39-86 years) underwent two identical examinations at 1.5 T by using three-dimensional spoiled gradient-echo sequences and randomized 0.1-mmol/kg doses of each agent. Images were evaluated on-site for technical adequacy and quality of vessel visualization and offsite by three independent blinded readers for anatomic delineation and detection/exclusion of pathologic features. Comparative diagnostic performance was determined in 31 patients who underwent digital subtraction angiography. Data were analyzed by using the Wilcoxon signed-rank, McNemar, and Wald tests. Interreader agreement was determined by using generalized k statistics. Differences in quantitative contrast enhancement were assessed and a safety evaluation was performed. Results: Ninety-two patients received both agents. Significantly better performance (P < .0001; all evaluations) with gadobenate dimeglumine was noted on-site for technical adequacy and vessel visualization quality and offsite for anatomic delineation and detection/exclusion of pathologic features. Contrast enhancement (P < .0001) and detection of clinically relevant disease (P < .0028) were significantly improved with gadobenate dimeglumine. Interreader agreement for stenosis detection and grading was good to excellent (k = 0.749 and 0.805, respectively). Mild adverse events were reported for four (six events) and five (eight events) patients after gadobenate dimeglumine and gadopentetate dimeglumine, respectively. Conclusion: Higher- quality vessel visualization, greater contrast enhancement, fewer technical failures, and improved diagnostic performance are obtained with gadobenate dimeglumine, relative to gadopentetate dimeglumine, when compared intraindividually at 0.1-mmol/kg doses in patients undergoing contrast-enhanced MR angiography for suspected peripheral arterial occlusive disease. (c) RSNA, 2010
引用
收藏
页码:988 / 1000
页数:13
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