Randomized trial of contrast media utilization in high-risk PTCA - The COURT trial

Background-Previous in vitro and in vivo studies have suggested an associat ion between thrombus-related events and type of contrast media, Low osmolar contrast agents appear to improve the safety of diagnostic and coronary ar tery interventional procedures. However, no data are available on PTCA outc omes with an isosmolar contrast agent. Methods and Results-A multicenter prospective randomized double-blind trial was performed in 856 high-risk patients undergoing coronary artery interve ntion. The objective was to compare the isosmolar nonionic dimer iodixanol (n=405) with the low osmolar ionic agent ioxaglate (n=410). A composite var iable of in-hospital major adverse clinical events (MACE) was the primary e nd point. A secondary objective was to evaluate major angiographic and proc edural events during and after PTCA, The composite in-hospital primary end point was less frequent in those receiving iodixanol compared with those re ceiving ioxaglate (5.4% versus 9.5%, respectively; P=0.027), Core laborator y defined angiographic success was more frequent in patients receiving iodi xanol (92.2% versus 85.9% fur ioxaglate, P=0.004), There was a trend toward lower total clinical events at 30 days in patients randomized to iodixanol (9.1% versus 13.2% for ioxaglate, P=0.07), Multivariate predictors of in-h ospital MACE were use of ioxaglate (P=0.01) and treatment of a de novo lesi on (P=0.03), Conclusions-In this contemporary prospective multicenter trial of PTCA in t he setting of acute coronary syndromes, there was a low incidence of in-hos pital clinical events for both treatment groups The cohort receiving the no nionic dimer iodixanol experienced a 45% reduction in in-hospital MACE when compared with the cohort receiving ioxaglate.