Why the study?
The radiopacity and complications of two contrast agents used in selective coronary arteriography were compared to assess safety and efficacy in patients with and without cardiac disease.
Observational (n=2,258)
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The radiopacity and complications of meglumine iothalamate 52% and sodium iothalamate 26% (Vascoray) were compared with those of meglumine diatrizoate 66% and sodium diatrizoate 10% (Renografin -76) in 2258 patients with and without cardiac disease. There was no difference in radiopacity and the type and incidence of adverse reactions were similar, but the frequency was significantly higher (p less than 0.05) with Vascoray in patients with constrictive pericarditis, dissecting aortic aneurysm, and primary pulmonary hypertension. The difference in the frequency of hypotension, sinus bradycardia, and transient asystole in the Renografin -76 and Vascoray groups was statistically significant. Ventricular arrhythmias occurred in 6% of the patients with primary myocardial disease compared to an average of 0.7% in those without this cardiac abnormality (p less than 0.01), but there was no significant difference in the frequency in the two contrast agent groups. All reactions were treated and the studies were performed without mortality. Results of this study show that iothalamate formulation with sodium to meglumine ratio of 1:2 containing 410 mEq/L of sodium (Vascoray) is suitable and safe for clinical use for roentgenographic studies of the heart, and coronary artery circulation.
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Shirey et al. (1983) conducted an observational in Cardiac disease (n=2,258). Meglumine iothalamate 52% and sodium iothalamate 26% (Vascoray) vs. Meglumine diatrizoate 66% and sodium diatrizoate 10% (Renografin-76) was evaluated on Radiopacity and complications (adverse reactions).
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