COMPARISON OF IOPROMIDE WITH IOHEXOL AND IOPAMIDOL IN CORONARY ARTERIOGRAPHY AND LEFT VENTRICULOGRAPHY

RATIONALE AND OBJECTIVES. Low-osmolality contrast agents, ionic and no nionic, are being used more frequently in coronary arteriography. A ne w nonionic contrast agent, iopromide, has recently become available fo r use in clinical trials. The purpose of this phase II-phase III Food and Drug Administration (FDA) trial was to compare the side effects an d diagnostic quality of iopromide with iohexol and iopamidol for coron ary arteriography and left ventriculography. METHODS. TWO separate dou ble-blind trials were performed using iopromide and comparison nonioni c contrast agents. In the first trial, 41 patients were randomized to receive iopromide or iopamidol. The second trial was a three-center tr ial involving 120 patients, of whom half received iopromide (370 mg I/ mL) and the other half received iohexol (350 mg I/mL), In a third stud y, 26 patients received iopromide (370 mg I/mL) according to an open-l abel design. RESULTS. Comparison of iopromide with the other agents re vealed that there were no significant differences in adverse events be tween iopromide and the comparison agents. Most adverse reactions were mild or moderate in severity in all patient groups. There was no diff erence in the patients' perceptions of heat and pain and no statistica lly significant difference in systolic or diastolic blood pressure at baseline, at 30 to 60 minutes, or at 24 hours after the procedure. No difference was found in the biochemical or hematologic analysis at bas eline or at 24-hour follow-up. No difference between the contrast medi a groups in terms of the quality of the left ventriculogram or the qua lity of the coronary arteriography was noted. CONCLUSION. Compared to the other nonionic agents, iopromide showed no statistically significa nt differences in terms of safety or efficacy.