Influence of a nonionic, iso-osmolar contrast medium (iodixanol) versus anionic, low-osmolar contrast medium (ioxaglate) on major adverse cardiac events in patients undergoing percutaneous transluminal coronary angioplasty a multicenter, randomized, double-blind study

Background-The potential merits and disadvantages of the use of ionic or no nionic contrast media in patients undergoing percutaneous transluminal coro nary angioplasty (PTCA) have been the subjects of controversy. The present study was designed to evaluate the possible influence of both types of cont rast media on major adverse cardiac events (MACE) in patients undergoing PT CA. Methods and Results-In a randomized, parallel-group, double-blind study, 14 11 patients received either iodixanol (a nonionic, iso-osmolar contrast med ium) or ioxaglate (an ionic, low-osmolar contrast medium) during PTCA. A st andardized anticoagulation regimen was followed. Patients were monitored in the hospital for 2 days and followed-up at 1 month. The primary end point, a composite of MACE (death, stroke, myocardial infarction, coronary artery bypass grafting, and re-PTCA) after 2 days, occurred in 4.3% of the total population, with no statistically significant difference between groups (io dixanol, 4.7%; ioxaglate, 3.9%; P=0.45). Further, between 2-day and 1-month follow-ups, no significant difference (P=0.27) existed between the groups in the rates of MACE. Hypersensitivity reactions (P=0.007) and adverse drug reactions (P=0.002) were significantly less frequent in the iodixanol grou p. The only significant predicting factors for the occurrence of MACE were dissection/abrupt closure and country. Conclusions-No significant differences were observed between the iodixanol and ioxaglate groups with regard to MACE, although hypersensitivity and adv erse drug reactions were significantly less frequent in patients who receiv ed iodixanol.