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Circulation. 2007;115:3189-3196
Published online before print June 11, 2007, doi: 10.1161/CIRCULATIONAHA.106.671644
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(Circulation. 2007;115:3189-3196.)
© 2007 American Heart Association, Inc.


Interventional Cardiology

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.

Correspondence to Richard J. Solomon, MD, Fletcher Allen Health Care, University of Vermont, UHC 2309, 1 South Prospect St, Burlington, VT 05401. E-mail richard.solomon{at}vtmednet.org

Received September 19, 2006; accepted April 30, 2007.

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.


 

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