title: Renal tolerability of iopromide and iodixanol in 562 renally impaired patients undergoing cardiac catheterisation: the DIRECT study.
abstract: OBJECTIVE
  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).
  
  
  RESULTS
  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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Cardiology, Chinese PLA General Hospital, Beijing 100853, China. cyundai@medmail.com.cn
authors.forename: Yundai
authors.initials: Y
authors.lastname: Chen
authors.forename: Shunying
authors.initials: S
authors.lastname: Hu
authors.forename: Yin
authors.initials: Y
authors.lastname: Liu
authors.forename: Ru
authors.initials: R
authors.lastname: Zhao
authors.forename: Lefeng
authors.initials: L
authors.lastname: Wang
authors.forename: Guosheng
authors.initials: G
authors.lastname: Fu
authors.forename: Qing
authors.initials: Q
authors.lastname: He
authors.forename: Xi
authors.initials: X
authors.lastname: Su
authors.forename: Yang
authors.initials: Y
authors.lastname: Zheng
authors.forename: Xiangqian
authors.initials: X
authors.lastname: Qi
authors.forename: Huiliang
authors.initials: H
authors.lastname: Liu
authors.forename: Jianan
authors.initials: J
authors.lastname: Wang
authors.forename: Wei
authors.initials: W
authors.lastname: Gao
authors.forename: Mingsheng
authors.initials: M
authors.lastname: Wang
authors.forename: Shaowen
authors.initials: S
authors.lastname: Liu
authors.forename: Xing
authors.initials: X
authors.lastname: Zheng
authors.forename: Ben
authors.initials: B
authors.lastname: He
authors.forename: Ping
authors.initials: P
authors.lastname: Yang
authors.forename: Shenghua
authors.initials: S
authors.lastname: Zhou
authors.forename: Chuanyu
authors.initials: C
authors.lastname: Gao
authors.forename: Chunguang
authors.initials: C
authors.lastname: Qiu
mesh_terms: D000368:Aged; D015415:Biomarkers / Q000097:blood; D006328:Cardiac Catheterization / Q000009:adverse effects; D002681:China / Q000453:epidemiology; D003287:Contrast Media / Q000009:adverse effects; D017023:Coronary Angiography / Q000009:adverse effects; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging* / Q000453:epidemiology / Q000628:therapy*; D003404:Creatinine / Q000097:blood; D003920:Diabetes Mellitus / Q000453:epidemiology; D004311:Double-Blind Method; D005260:Female; D005440:Fluid Therapy; D005919:Glomerular Filtration Rate; D006801:Humans; D015994:Incidence; D007472:Iohexol / Q000009:adverse effects / Q000031:analogs & derivatives*; D007668:Kidney / Q000378:metabolism / Q000503:physiopathology*; D007674:Kidney Diseases / Q000097:blood / Q000453:epidemiology* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects; D011237:Predictive Value of Tests; D015995:Prevalence; D051437:Renal Insufficiency / Q000139:chemically induced / Q000453:epidemiology; D016896:Treatment Outcome; D014283:Triiodobenzoic Acids / Q000009:adverse effects
chemical_list: D015415:Biomarkers; D003287:Contrast Media; D014283:Triiodobenzoic Acids; D007472:Iohexol; C038192:iopromide; D003404:Creatinine; C044834:iodixanol