A multicenter randomized trial of ionic (ioxaglate) and nonionic (iopamidol) low‐osmolality contrast agents in cardiac angiography

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Abstract
A multicentered double‐blind randomized study was performed comparing the electrocardiographic and hemodynamic changes induced by two new low osmolar contrast agents used for cardiac angiography. The low osmolar ionic (ioxaglate) contrast agent was compared with a low osmolar nonionic (iopamidol) contrast agent in 150 patients with angina pectoris undergoing angiography. Systolic blood pressure, left ventricular enddiastolic pressure, heart rate, and QT interval were measured just before and for 90s following the left ventricular angiography and selective coronary angiography. Each group was also evaluated for adverse events and quality of radiographic images. Following left ventricular angiography, the systolic blood pressure dropped slightly in both groups with a greater decrease seen in the iopamidol group at 5 s (p<0.05). After selective right and left coronary angiography, systolic blood pressure decreased transiently and equally in both treatment groups. The left ventricular end‐diastolic pressure increased after the ventriculogram in both groups (15.9±6.3 to 18.9±8.6 mmHg in the ioxaglate group and 16.1±6.7 to 20.1±7.8 mmHg in the iopamidol group), the change being significant only in the iopamidol group (p<0.05). Heart rate increased slightly but significantly in the ioxaglate‐treated patients following left ventricular angiography (71.4±15.2 to 74.4±13.7 beats/min) (p<0.01). QT interval transiently increased following left ventriculography with ioxaglate (407±59.5 to 420±58.3 ms) (p<0.05) compared with iopamidol. Following coronary angiography the QT interval increased transiently but significantly in the ioxaglate group compared to iopamidol (p<0.05) for right coronary artery, p<0.01 for left coronary artery). However, no significant change from baseline was observed at 90 s. No significant change in QT interval or heart rate was seen with iopamidol‐treated patients. Side effects were infrequent in both groups. Nausea was more frequent with ioxaglate injection than with iopamidol (10 patients versus 1 patient) (p<0.01) as was hives (8 patients versus 1 patient) (p<0.05). No severe life‐threatening adverse effects occurred. There was no difference in the quality of radiographic images obtained with either contrast agent. Electrocardiographic and hemodynamic changes are minimal with both contrast agents and no clinically important changes were seen with either group. In conclusion, both low osmolar contrast agents are safe for use in cardiac angiography although the incidence of nausea and hives occurs more frequently with the use of ioxaglate.