COMPARISON OF IOTROLAN-320 AND IOHEXOL-350 IN CARDIAC ANGIOGRAPHY - ARANDOMIZED DOUBLE-BLIND CLINICAL-STUDY

Objective: A double-blind randomised study was conducted in two Britis h centres, to evaluate the safety, tolerance and efficacy of the new d imeric non-ionic contrast medium Iotrolan 320 in comparison with the m onomeric non-ionic compound Iohexol 350 in coronary angiography. Metho ds and Material: 120 patients were randomised to receive either Iotrol an at a concentration of 320 mgI/ml or Iohexol at a concentration of 3 50 mgI/ml, during selective coronary angiography and left ventriculogr aphy. The variables measured were: maximum increase of the left ventri cular end-diastolic pressure up to 6 min after ventriculography, haemo dynamic and electrocardiographic variables, arrhythmogenicity, clinica l laboratory parameters, tolerance, adverse events and efficacy. Resul ts: Iotrolan resulted in a smaller change of left ventricular end-dias tolic pressure compared to Iohexol, but the difference was not statist ically significant. Transient changes in left ventricular systolic pre ssure, intra-arterial systolic pressure, intra-arterial diastolic pres sure, and in electrocardiographic parameters, occurred after the injec tions, but they were not clinically significant. Changes in the clinic al laboratory markers from baseline values were comparable between the two groups and confirmed good renal and hepatic tolerance. During the left ventriculogram, Iotrolan resulted in less symptoms compared to I ohexol (P = 0.002). Adverse events, which were mild or moderate in mos t cases, were observed with no statistical difference between the two agents. The contrast quality of both agents was good with no statistic al difference. Conclusion: This study did not show a significant diffe rence between Iotrolan 320 and Iohexol 350 with regard to cardiovascul ar safety or patient tolerance, except for a minor difference in the i ntensity of heat/warmth sensation. (C) 1998 Elsevier Science Ireland L td. All rights reserved.