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Iodixanol in femoral arteriography (phase III): a comparative double-blind parallel trial between iodixanol and
N D Pugh1, G R Sissons, M S Ruttley
1Department of Medical Physics, University Hospital of Wales, Cardiff, UK.
Insights
This study compared iodixanol and iopromide, two contrast media (CM), in aortofemoral arteriography. Both were safe and effective, with iodixanol causing less warmth sensation and a smaller increase in femoral blood flow.
Area of Science:
- Radiology
- Vascular Imaging
- Contrast Media Research
Background:
- Iodixanol is a non-ionic, dimeric contrast medium (CM) designed to be isotonic with blood.
- Iopromide is another commonly used non-ionic CM.
Purpose of the Study:
- To compare the safety and efficacy of iodixanol versus iopromide in aortofemoral arteriography.
- To evaluate radiographic quality, patient discomfort, adverse events, femoral blood flow, and renal function.
Main Methods:
- A parallel, double-blind study involving 100 patients undergoing peripheral arteriography.
- Patients were randomly assigned to receive either iodixanol or iopromide.
- Assessment included radiographic quality, adverse events, patient-reported warmth sensation, femoral blood flow measurements, and renal function markers.
Main Results:
- Radiographic quality was similar between iodixanol and iopromide.
- Adverse events were mild and transient, with no significant difference between groups (6% iodixanol vs. 11% iopromide).
- Iodixanol resulted in a significantly milder sensation of warmth and a smaller increase in femoral blood flow compared to iopromide. Renal function was minimally affected by both, with differing impacts on specific markers.
Conclusions:
- Both iodixanol and iopromide are safe, effective, and well-tolerated contrast media for aortofemoral arteriography.
- The primary difference lies in their hemodynamic effects, with iodixanol showing a lesser impact on femoral blood flow and patient-reported warmth.
Abstract:
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.
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