PURPOSE:
To assess the diagnostic efficacy of Xenetix 350 compared to Iomeron 400 in the visualization of the abdominal aorta and visceral arteries.
MATERIALS AND METHODS:
In this randomized, double-blind, phase IV trial, 310 patients scheduled for MSCTA of the abdominal arteries were included in nine European centres. Patients underwent MSCTA after administration of either Xenetix or Iomeron, each centre applying its own current injection protocol. Diagnostic efficacy, image quality, arterial enhancement and general tolerance were evaluated.
RESULTS:
Of the 310 study patients, three patients were excluded from evaluation for technical problems. 153 patients receiving Xenetix(average dose:35.4g iodine) and 154 Iomeron(average dose:40.6g iodine) were evaluated. The ability of diagnostic assessment was “satisfactory” to “totally satisfactory” in 152 (99.3%) and 153 (99.4%), and the image quality was rated as “good” to “excellent” in 94.7% and 94.8% (Xenetix versus Iomeron), respectively. Regarding the relative arterial enhancement, no significant difference was found (p = 0.0673). The good safety of both products was also confirmed.
CONCLUSION:
This large study demonstrated the equivalence between Xenetix 350 and Iomeron 400 in terms of diagnostic efficacy in abdominal MSCTA and confirms the high reliability of this technique through multinational practices.
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SS 06 CV-07.pdf
