Published Online
on June 11, 2007

A more recent version of this article appeared on June 26, 2007

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Submitted on September 19, 2006
Accepted on April 30, 2007

Cardiac Angiography in Renally Impaired Patients (CARE) Study. A Randomized Double-Blind Trial of Contrast-Induced Nephropathy in Patients With Chronic Kidney Disease

Richard J. Solomon MD^*, Madhu K. Natarajan MD, Serge Doucet MD, Samin K. Sharma MD, Cezar S. Staniloae MD, Richard E. Katholi MD, Joseph L. Gelormini MD, Marino Labinaz MD, Abel E. Moreyra MD, the Investigators of the CARE Study

From the Department of Renal Services (R.J.S.), Fletcher Allen Health Care, Burlington, Vt.; Division of Cardiology (M.K.N.), Hamilton Health Sciences General Division, Hamilton, Ontario, Canada; Department of Medicine (S.D.), Montreal Heart Institute, University of Montreal, Quebec, Canada; Cardiovascular Institute (S.K.S.), Mount Sinai Medical Center, New York, NY; Comprehensive Cardiovascular Center (C.S.S.), St. Vincent’s Medical Center Manhattan, New York, NY; Department of Medicine (R.E.K.), Southern Illinois University, Springfield; Interventional Cardiology (J.L.G.), Buffalo Heart Group, Buffalo, NY; Department of Medicine (M.L.), Division of Cardiology, University of Ottawa Heart Institute, Ottawa, Ontario, Canada; Department of Medicine (A.E.M.), Division of Cardiology, Robert Wood Johnson Medical School, New Brunswick, NJ.

^* To whom correspondence should be addressed. E-mail: richard.solomon{at}vtmednet.org.

Background--No direct comparisons exist of the renal tolerability of the low-osmolality contrast medium iopamidol with that of the iso-osmolality contrast medium iodixanol in high-risk patients.

Methods and Results--The present study is a multicenter, randomized, double-blind comparison of iopamidol and iodixanol in patients with chronic kidney disease (estimated glomerular filtration rate, 20 to 59 mL/min) who underwent cardiac angiography or percutaneous coronary interventions. Serum creatinine (SCr) levels and estimated glomerular filtration rate were assessed at baseline and 2 to 5 days after receiving medications. The primary outcome was a postdose SCr increase 0.5 mg/dL (44.2 µmol/L) over baseline. Secondary outcomes were a postdose SCr increase 25%, a postdose estimated glomerular filtration rate decrease of 25%, and the mean peak change in SCr. In 414 patients, contrast volume, presence of diabetes mellitus, use of N-acetylcysteine, mean baseline SCr, and estimated glomerular filtration rate were comparable in the 2 groups. SCr increases 0.5 mg/dL occurred in 4.4% (9 of 204 patients) after iopamidol and 6.7% (14 of 210 patients) after iodixanol (P=0.39), whereas rates of SCr increases 25% were 9.8% and 12.4%, respectively (P=0.44). In patients with diabetes, SCr increases 0.5 mg/dL were 5.1% (4 of 78 patients) with iopamidol and 13.0% (12 of 92 patients) with iodixanol (P=0.11), whereas SCr increases 25% were 10.3% and 15.2%, respectively (P=0.37). Mean post-SCr increases were significantly less with iopamidol (all patients: 0.07 versus 0.12 mg/dL, 6.2 versus 10.6 µmol/L, P=0.03; patients with diabetes: 0.07 versus 0.16 mg/dL, 6.2 versus 14.1 µmol/L, P=0.01).

Conclusions--The rate of contrast-induced nephropathy, defined by multiple end points, is not statistically different after the intraarterial administration of iopamidol or iodixanol to high-risk patients, with or without diabetes mellitus. Any true difference between the agents is small and not likely to be clinically significant.

Key words: contrast media • diabetic nephropathy • iodixanol • iopamidol • kidney

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