Cardiac Angiography in Renally Impaired Patients (CARE) study: a randomized double-blind trial of contrast-induced nephropathy in patients with chronic kidney disease.
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.


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 > or = 0.5 mg/dL (44.2 micromol/L) over baseline. Secondary outcomes were a postdose SCr increase > or = 25%, a postdose estimated glomerular filtration rate decrease of > or = 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 > or = 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 > or = 25% were 9.8% and 12.4%, respectively (P=0.44). In patients with diabetes, SCr increases > or = 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 > or = 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 micromol/L, P=0.03; patients with diabetes: 0.07 versus 0.16 mg/dL, 6.2 versus 14.1 micromol/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.
Solomon
Richard J
RJ
Department of Renal Services, Fletcher Allen Health Care, University of Vermont, Burlington, VT 05401, USA. richard.solomon@vtmednet.org
Natarajan
Madhu K
MK
Doucet
Serge
S
Sharma
Samin K
SK
Staniloae
Cezar S
CS
Katholi
Richard E
RE
Gelormini
Joseph L
JL
Labinaz
Marino
M
Moreyra
Abel E
AE
D000368:Aged; D000369:Aged, 80 and over; D006328:Cardiac Catheterization; D002908:Chronic Disease; D003287:Contrast Media / Q000008:administration & dosage / Q000009:adverse effects* / Q000737:chemistry; D003404:Creatinine / Q000097:blood; D004311:Double-Blind Method; D005260:Female; D005919:Glomerular Filtration Rate; D006801:Humans; D015994:Incidence; D007269:Injections, Intra-Arterial; D007479:Iopamidol / Q000008:administration & dosage / Q000009:adverse effects* / Q000737:chemistry; D007674:Kidney Diseases / Q000097:blood / Q000139:chemically induced* / Q000150:complications / Q000453:epidemiology / Q000517:prevention & control; D008297:Male; D008875:Middle Aged; D009994:Osmolar Concentration; D011446:Prospective Studies; D014283:Triiodobenzoic Acids / Q000008:administration & dosage / Q000009:adverse effects* / Q000737:chemistry
D003287:Contrast Media; D014283:Triiodobenzoic Acids; D003404:Creatinine; C044834:iodixanol; D007479:Iopamidol