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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 B, Cheng WJ, Li YF, Cao Z, Yang Q, Zhao YX, Guo YH, Zhou YJ

Affiliation(s): Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, People's Republic of China.

Publication date & source: 2008-12-01, Catheter Cardiovasc Interv., 72(7):958-65.

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 < or =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) > or =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. Copyright 2008 Wiley-Liss, Inc.

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