INJECTION-ASSOCIATED PAIN IN FEMORAL ARTERIOGRAPHY - A EUROPEAN MULTICENTER STUDY COMPARING SAFETY, TOLERABILITY, AND EFFICACY OF IODIXANOLAND IOPROMIDE

Purpose: To evaluate injection-associated pain, safety, and efficacy w ith the isotonic contrast medium iodixanol (Visipaque 270 mg I/ml) com pared with iopromide (Ultravist 300 mg I/ml) in femoral arteriography. Methods: A multicenter, double-blind, randomized, parallel-group clin ical investigation was carried out in 54 hospitals in Europe, Of the p atients evaluated, 1225 received iodixanol and 1227 iopromide in conve ntional and/or digital subtraction angiography, Results: The iodixanol group reported statistically significantly less injection-associated pain (0.9%) than the iopromide group (9.5%) (p < 0.001). Further, 4.1% in the iodixanol group experienced pain and/or severe heat sensation vs 19.8% in the iopromide group (p < 0.001), In the iodixanol group, 1 .8% of the patients experienced contrast-related adverse events vs 2.4 % in the iopromide group (p = NS), Overall diagnostic information was optimal for 94.1% in the iodixanol group and 95.3% in the iopromide gr oup (p = NS). Conclusions: Iodixanol 270 mg I/ml causes significantly less injection-associated pain during femoral arteriography and is as safe and efficacious as iopromide 300 mg I/ml.