Iodixanol in femoral arteriography (phase III): a comparative double-blind parallel trial between iodixanol and iopromide.

Iodixanol is a new non-ionic, dimeric contrast medium (CM) which is formulated to be isotonic with blood in all clinically relevant concentrations. This is a report of a parallel, double-blind study comparing the safety and efficacy of iodixanol with iopromide (Ultravist) in aortofemoral arteriography. One hundred consecutive, eligible patients scheduled to undergo peripheral arteriography were entered into the study and randomly allocated to receive one or other CM. Radiographic quality, discomfort, adverse events, femoral blood flow and renal function were examined. Ninety-five patients were successfully included in the study. Radiographic quality (efficacy) was found to be similar in both groups. Three patients (6%) in the iodixanol group and five patients (11%) in the iopromide group reported adverse events. In this respect there was no statistically significant difference between the two groups (P = 0.48), and all adverse events were mild and transient. Forty-six (97%) patients in the iodixanol group and 45 (100%) patients in the iopromide group experienced a sensation of warmth (discomfort) in connection with one or more of the injections. There was no statistically significant difference in the frequency of discomfort in the two groups. However, the intensity of warmth was significantly milder following iodixanol than after iopromide (P = 0.003, two-sided Mantel-Haenszel test). The mean percentage increase in femoral blood flow was found to be less with iodixanol (43.4%) than with iopromide (96.3%) (P < 0.05, Student's t-test). Renal function was affected slightly after administration of both CM. Serum creatinine and creatinine clearance were affected more by iodixanol than by iopromide, while the excretion of tubular enzymes was more affected by iopromide. In conclusion, this comparison between iodixanol and iopromide showed both contrast media to be safe, effective and well tolerated and the only major difference between them was in their effect on femoral blood flow.

RCT Entities:   Population Interventions Outcomes