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A prospective, double‐blind, randomized, controlled trial on the efficacy and cardiorenal safety of iodixanol vs. iopromide in patients with chronic kidney disease undergoing coronary angiography with or without percutaneous coronary intervention
Author(s) -
Nie Bin,
Cheng WanJun,
Li YanFang,
Cao Zheng,
Yang Qing,
Zhao YingXin,
Guo YongHe,
Zhou YuJie
Publication year - 2008
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.21713
Subject(s) - iodixanol , medicine , iopromide , contrast induced nephropathy , kidney disease , percutaneous coronary intervention , coronary artery disease , clinical endpoint , randomized controlled trial , creatinine , urology , acute kidney injury , cardiology , gastroenterology , contrast medium , radiology , myocardial infarction
Objectives: This study was undertaken to compare the renal safety as well as cardiovascular (CV) effects and diagnostic image quality of iso‐osmolar iodixanol vs. low‐osmolar iopromide in patients with chronic kidney disease (CKD) undergoing coronary interventions. Background: With the growing number of contrast‐enhanced procedures being performed for coronary artery disease management, the safety and efficacy of iodinated contrast media (CM) have come under increased scrutiny. Methods: Patients with CKD (CrCl ≤60 mL/min) were randomized to iodixanol ( n = 106) or iopromide ( n = 102). The primary endpoint was incidence of contrast‐induced nephropathy (CIN), defined as an increase in serum creatinine (SCr) ≥25% or 0.5 mg/dL within 72 hr of CM administration. Secondary endpoints were mean SCr increase, a composite of CV events in‐hospital and 30 days postdischarge, and diagnostic image quality. Results: CIN incidence was significantly lower with iodixanol than iopromide (5.7% vs. 16.7%; P = 0.011). Baseline SCr (OR 2.21, 95% CI: 1.25–3.47; P = 0.031), iopromide use (OR 2.56, 95% CI: 1.18–5.76; P = 0.024), and CM volume (OR 2.01, 95% CI: 1.01–3.21; P = 0.038) were identified as independent risk factors for CIN. Cardiovascular events were reduced with iodixanol (1.9% vs. 8.8%; P = 0.025); diagnostic image quality was similar for both CM ( P = 0.353). Conclusions: Consistent with several previous trials comparing iso‐osmolar iodixanol and low‐osmolar comparator CM, iodixanol was associated with a lower incidence of CIN and fewer CV events than iopromide. © 2008 Wiley‐Liss, Inc.