Cardiac Angiography in REnally impaired patients - CARE

Oct 27, 2006
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Trial Sponsor:
Bracco Diagnostics Inc.
Date Presented:
01/01/2006
Date Published:
01/01/2007
Date Updated:
10/27/2006
Original Posted Date:
10/27/2006
References

Description:

The goal of the trial was to compare the low osmolar contrast iopamidol versus the iso-osmolar contrast iodixanol among patients at high risk for contrast-induced nephropathy undergoing coronary angiography.

Study Design

Study Design:

Patients Enrolled: 414
Mean Follow Up: Up to 96 hours
Mean Patient Age: Mean age 72 years
Female: 36

Patient Populations:

Age ≥18 years; documented eGFR 20 to <60 ml/min/1.73m2 within 72 hours of enrollment; and scheduled for coronary angiography

Exclusions:

History of sensitivity to dye; New York Heart Association class IV heart failure; hyperthyroidism; unstable renal function or dialysis; recent prior contrast dye; loop diuretics within 24 hours of contrast; use of renally toxic medications, including nonsteroidal anti-inflammatory drugs and aminoglycosides; or planned use of adenosine or dipyridamole during angiography

Primary Endpoints:

Contrast-induced nephropathy

Drug/Procedures Used:

Patients scheduled for angiography were randomized to iopamidol (n = 204) or iodixanol (n = 210). Patients were treated with intravenous sodium bicarbonate. N-acetyl-cysteine (NAC) was used at some centers. Serum creatinine was re-checked >45 hours after contrast administration. All serum creatinine analyses were performed at a single laboratory.

Principal Findings:

At baseline, mean estimated glomerular filtration rate (eGFR) was 50 ml/min/1.73m2. Diabetes was present in 41% of patients. Percutaneous coronary intervention (PCI) was performed in 39% of patients. Mean contrast volume used did not differ between groups (133.7 ml for iopamidol vs. 136.4 ml for iodixanol). NAC was used in 41% of patients. Post-contrast serum creatinine was measured by 45-71 hours in 83% of patients.

Contrast-induced nephropathy did not differ between treatment groups, whether defined as an increase in serum creatinine ≥0.5 mg/dl (4.4% for iopamidol vs. 6.7% for iodixanol, p = 0.39), increase in serum creatinine ≥25% (9.8% vs. 12.4%, p = 0.44), or reduction in eGFR by ≥25% (5.9% vs. 10.0%, p = 0.15). Results were similar in the diabetic subgroup and in patients treated with NAC. However, among patients who underwent PCI, a reduction in eGFR by ≥25% was more frequent in the iodixanol group (1.2% vs. 12.2%, p = 0.01). Mean change in peak serum creatinine was 0.07 mg/dl for iopamidol versus 0.12 mg/dl for iodixanol (p = 0.03).

Interpretation:

Among patients at high risk for contrast-induced nephropathy undergoing coronary angiography, there was no difference between use of the low osmolar contrast iopamidol versus the iso-osmolar contrast iodixanol in rates of contrast-induced nephropathy, despite a slightly larger increase in mean serum creatinine with iodixanol.

Results were similar in diabetic patients and in patients also treated with NAC. It should be noted that patients in the present study were also treated with IV sodium bicarbonate to ensure proper hydration, as was done in the recent ICON trial, which also showed no significant benefit of iodixanol.

References:

Solomon RJ, et al. Cardiac Angiography in Renally Impaired Patients (CARE) Study: A Randomized Double-Blind Trial of Contrast-Induced Nephropathy in Patients With Chronic Kidney Disease. Circulation. 2007;115:epub before print.

Presented by Dr. Richard Solomon at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2006), Washington, DC, October 2006.

Keywords: Triiodobenzoic Acids, Iopamidol, Coronary Disease, Sodium Bicarbonate, Creatinine, Percutaneous Coronary Intervention, Contrast Media, Kidney Diseases, Coronary Angiography, Glomerular Filtration Rate, Diabetes Mellitus


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