A DOUBLE-BLIND COMPARATIVE-STUDY OF THE SAFETY AND EFFICACY OF IOMEPROL IN RENAL INTRAARTERIAL DIGITAL SUBTRACTION ANGIOGRAPHY

This randomised, double-blind, parallel group study was to compare the safety, tolerance and diagnostic efficacy of iomeprol and iopamidol, both at an iodine concentration of 150 mgI/ml, in 40 patients with art erial hypertension who required renal intraarterial digital subtractio n angiography (IA-DSA) for suspected renovascular stenosis. All patien ts underwent extensive pre- and post-contrast clinical, instrumental a nd laboratory controls for safety assessments. The tolerance to the te st contrast media was evaluated in terms of discomfort associated with the injection of the test compounds. Image quality was prospectively graded by two independent readers according to a five-point scale as f ollows: 1, insufficient; 2, sufficient; 3, good; 4, excellent; E, exce ssive. The quality of vascular opacification in the region of interest was rated as diagnostic in 87.8% of radiographs obtained in the iomep rol group and in 84.5% in the iopamidol group, without significant dif ferences between the two study groups. The results of angiography were always useful for subsequent patient management. The procedure was al ways well tolerated. There were no clinically significant changes in v ital signs, ECG and laboratory parameters during the study in both gro ups. The results of our study show that iomeprol 150 mgI/ml, and iopam idol 150 mgI/ml are equally effective, well tolerated and safe contras t agents when used for IA-DSA.