U. Ugolotti et al., PERIPHERAL ARTERIOGRAPHY WITH A NEW NONIONIC AGENT - COMPARISON OF IOMEPROL WITH IOPAMIDOL, European journal of radiology, 18, 1994, pp. 190000077-190000082
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.