Renal tolerability of iopromide and iodixanol in 562 renally impaired patients undergoing cardiac catheterisation: the DIRECT study

Abstract

This multi-centre, randomised, double-blind study compared the nephrotoxicity of low-osmolar, low-viscous iopromide and iso-osmolar, high-viscous iodixanol in Chinese patients with moderate renal dysfunction, after coronary angiography or percutaneous coronary intervention (PCI). The primary endpoint was contrast-induced nephropathy (CIN) on day 3, defined as a post-dose increase in serum creatinine (SCr) of ≥50% from baseline. All patients were rigorously hydrated from six hours before intervention. In 562 evaluable patients (of 592 recruited), the contrast volume, presence of diabetes mellitus, mean baseline SCr and estimated glomerular filtration rate (eGFR) were comparable between the iopromide- and iodixanol-treated groups. SCr increases of ≥50% occurred in 1/278 (0.4%) of patients after iopromide and 1/284 (0.3%) after iodixanol. Incidences in the secondary endpoints were the following: SCr increases of ≥0.5 mg/dL, 1.4% and 0.7%, respectively; SCr increases of ≥25%, 5.4% and 2.8%; eGFR decreases of ≥25%, 3.6% and 2.5%. Only one patient showed renal failure, one week after dosing with iodixanol. All differences were statistically insignificant, in the overall collective group and in the subgroup with diabetes (n=170). With rigorous hydration, the CIN incidence was very low in patients with moderate renal dysfunction who underwent coronary angiography or PCI. No difference in nephrotoxicity was found between iopromide and iodixanol.