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

Autor: Angelo Vanzulli, Josef Vymazal, Henrik J. Michaely, Miles A. Kirchin, Claudio Ballarati, Martin N. J. M. Wasser, Gianpaolo Pirovano, Christoph U. Herborn, S.C. Gerretsen, Tim Leiner, Stephan Miller, Siegfried Thurnher, Harald Kramer, Thierry F le Maire
Přispěvatelé: MUMC+: DA BV Medisch Specialisten Radiologie (9), Beeldvorming, RS: CARIM School for Cardiovascular Diseases
Jazyk: angličtina
Rok vydání: 2010
Předmět:
Adult
Gadolinium DTPA
Male
medicine.medical_specialty
Contrast Media
Statistics
Nonparametric
Magnetic resonance angiography
Pelvis
Double blind
Meglumine
Double-Blind Method
Peripheral arterial occlusive disease
Organometallic Compounds
medicine
Humans
Radiology
Nuclear Medicine and imaging
Prospective Studies
GADOBENATE DIMEGLUMINE
Aged
Aged
80 and over
Peripheral Vascular Diseases
magnetic-resonance angiography digital-subtraction-angiography nephrogenic systemic fibrosis aortoiliac occlusive disease dose gadodiamide injection diagnostic performance contrast agents renal-arteries phase-iii 3 tesla
Cross-Over Studies
medicine.diagnostic_test
business.industry
Mr angiography
Middle Aged
Crossover study
Peripheral
Lower Extremity
Female
Radiology
business
Magnetic Resonance Angiography
medicine.drug
Zdroj: Radiology, 255(3), 988-1000. Radiological Society of North America, Inc.
Radiology, 255(3), 988-1000
ISSN: 0033-8419
Popis: 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
Databáze: OpenAIRE
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