A comparison of iodixanol with iopamidol in aorto-femoral angiography.

This double-blind, randomized, parallel group clinical investigation in 140 consecutive patients undergoing aorto-femoral arteriography was carried out to compare iodixanol (Visipaque) 270 mgI ml-1 with iopamidol (Iopamiro) 300 mgI ml-1. The aims of the study were to compare adverse events and discomfort, clinical chemistry parameters in blood, haemodynamics and diagnostic information of the angiograms in the two groups. The main parameter for statistical analysis was the visual analogue scale (VAS) score for overall discomfort experienced by the patients during the examination. 134 patients, 69 and 65 receiving iodixanol and iopamidol, respectively, were examined according to the protocol and included in the evaluation. The two groups of patients were judged to be comparative. Statistically significant milder discomfort was felt with iodixanol than with iopamidol (p = 0.0001); mean VAS values 16 mm and 51 mm, respectively. Pain was reported far less frequently after iodixanol than after iopamidol (7.4% versus 50.8%) whereas sensation of warmth was less intense after iodixanol than after iopamidol. Four patients in the iodixanol group and two in the iopamidol group reported transient, non-serious adverse events. The difference was not statistically significant (p = 0.68). Systolic blood pressure was affected to a slightly greater degree after injection of iopamidol than after injection of iodixanol. Measurements of diastolic blood pressure, as well as clinical chemistry parameters in blood, revealed no changes of clinical importance, and all arteriograms performed were of diagnostic value. The conclusion is that iodixanol 270 mgI ml-1 is as efficacious as iopamidol 300 mgI ml-1, but produces less discomfort during arteriography. As such, iodixanol is a good alternative to iopamidol in aorto-femoral angiography.

RCT Entities:   Population Interventions Outcomes