RESUMO
OBJECTIVE: A double-blind randomised study was conducted in two British centres, to evaluate the safety, tolerance and efficacy of the new dimeric non-ionic contrast medium Iotrolan 320 in comparison with the monomeric non-ionic compound Iohexol 350 in coronary angiography. METHODS AND MATERIAL: 120 patients were randomised to receive either Iotrolan at a concentration of 320 mgI/ml or Iohexol at a concentration of 350 mgI/ml, during selective coronary angiography and left ventriculography. The variables measured were: maximum increase of the left ventricular end-diastolic pressure up to 6 min after ventriculography, haemodynamic and electrocardiographic variables, arrhythmogenicity, clinical laboratory parameters, tolerance, adverse events and efficacy. RESULTS: Iotrolan resulted in a smaller change of left ventricular end-diastolic pressure compared to Iohexol, but the difference was not statistically significant. Transient changes in left ventricular systolic pressure, intra-arterial systolic pressure, intra-arterial diastolic pressure, and in electrocardiographic parameters, occurred after the injections, but they were not clinically significant. Changes in the clinical 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 Iohexol (P = 0.002). Adverse events, which were mild or moderate in most cases, were observed with no statistical difference between the two agents. The contrast quality of both agents was good with no statistical difference. CONCLUSION: This study did not show a significant difference between Iotrolan 320 and Iohexol 350 with regard to cardiovascular safety or patient tolerance, except for a minor difference in the intensity of heat/warmth sensation.