PERIPHERAL ARTERIOGRAPHY WITH A NEW NONIONIC AGENT - COMPARISON OF IOMEPROL WITH IOPAMIDOL

Aim of this randomized, double-blind, parallel group study was to comp are the safety, tolerance and diagnostic efficacy of iomeprol and iopa midol, both at iodine concentration of 150 mgI/ml, in 100 adult patien ts undergoing peripheral intra-arterial digital subtraction angiograph y (IA-DSA). All patients underwent extensive pre- and post-contrast cl inical, instrumental and laboratory evaluation for safety assessments. The tolerance to the test compounds was evaluated in terms of discomf ort associated with the injection of the test compounds. Image quality was prospectively graded by two independent readers according to a fi ve-point scale as 1, insufficient; 2, sufficient; 3, good; 4, excellen t; or E, excessive. At the end of the study, two experienced radiologi sts working at institutions other than the study centre and not aware of patients identity, clinical profile or results of other imaging pro cedures, jointly evaluated study images using the same ordinal scare. The procedure was always well tolerated. None of the studied patients experienced adverse events. All angiographic examinations were rated a s diagnostic. The quality of the radiographs was judged as excellent o r good in most individual patient studies, without significant differe nces between the two study groups. No significant differences between the results of prospective on-site assessment and retrospective extern al assessment were detected. The results of our study show that iomepr ol and iopamidol are equally effective, well tolerated and safe contra st agents when used for peripheral IA-DSA.