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Renal tolerability of iopromide and iodixanol in 562 renally impaired patients undergoing cardiac catheterisation: the DIRECT study.
MedLine Citation:
PMID:  23045301     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
Aims: 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). Methods and 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:
Yundai Chen; Shunying Hu; Yin Liu; Ru Zhao; Lefeng Wang; Guosheng Fu; Qing He; Xi Su; Yang Zheng; Xiangqian Qi; Huiliang Liu; Jianan Wang; Wei Gao; Mingsheng Wang; Shaowen Liu; Xing Zheng; Ben He; Ping Yang; Shenghua Zhou; Chuanyu Gao; Chunguang Qiu
Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-10-10
Journal Detail:
Title:  EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology     Volume:  -     ISSN:  1969-6213     ISO Abbreviation:  EuroIntervention     Publication Date:  2012 Oct 
Date Detail:
Created Date:  2012-10-9     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101251040     Medline TA:  EuroIntervention     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Affiliation:
Department of Cardiology, Chinese PLA General Hospital, Beijing, China.
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