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Submitted on September 19, 2006
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 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.
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*,
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).
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