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Ionic Versus Nonionic Contrast to Obviate Worsening Nephropathy After Angioplasty in Chronic Renal Failure Patients - ICON
Description:
The goal of the trial was to compare ionic versus nonionic contrast among patients with chronic renal insufficiency undergoing coronary angiography.
Study Design
Patients Enrolled: 145
Mean Follow Up: 30 days
Patient Populations:
Age ≥18 years; scheduled for angiography with or without percutaneous coronary intervention; chronic renal insufficiency, defined as two consecutive stable serum creatinine values of 1.5-3.0 mg/dl at least 24 hours apart; and willing to return between 48-72 hours post-injection for lab evaluations
Primary Endpoints:
Peak increase in creatinine concentration from day 0 to day 3
Drug/Procedures Used:
Patients scheduled for angiography were randomized to ioxaglate (n = 74) or iodixanol (n = 71). All patients were hydrated with 0.45 normal saline 100 cc/hour for 3-5 hours prior to contrast injection, during the procedure, and for ≥12 hours following contrast injection. Use of N-acetyl-cysteine was at the discretion of the investigator.
Principal Findings:
Diabetes was present in 45.5% of patients, hypertension in 88%, and hyperlipidemia in 82%. Mean baseline creatinine clearance was 45 cc/min. PCI was performed in 66% of patients, and 34% had diagnostic angiography alone. Mean contrast used was 204 cc in the ioxaglate group and 217 cc in the iodixanol group. Mean duration of contrast administration was approximately 50 minutes. N-acetyl-cysteine was used in 72% of patients.
There was no difference in the primary endpoint of mean increase in creatinine (0.35 mg/dl with ioxaglate vs. 0.20 mg/dl with iodixanol, p = 0.08). By 48-72 hours, mean serum creatinine was 2.13 mg/dl in the ioxaglate group and 1.99 mg/dl in the iodixanol group (p = 0.38). Creatinine increases of ≥25% were observed in 24.2% of the ioxaglate group and 16.2% of the iodixanol group (p = 0.29). There was no difference in in-hospital death (0 with ioxaglate vs. 2.8% with iodixanol, p = 0.24) or 30-day death (1.4% vs. 5.9%, respectively, p = 0.20). Acute renal failure also did not differ in-hospital (18.9% with ioxaglate vs. 11.3% with iodixanol, p = 0.25) or by 30 days (23.9% vs. 19.1%). Dialysis also did not differ (2.8% vs. 1.5%, respectively, by 30 days).
Interpretation:
Among patients with chronic renal insufficiency undergoing coronary angiography, use of the nonionic contrast agent iodixanol was not associated with differences in serum creatinine increases by day 3 compared with use of the ionic contrast agent ioxaglate.
Patients with chronic renal insufficiency undergoing angiography represent a particularly high-risk cohort. This was evident in the high rate of acute renal failure reported in the trial, which occurred in more than 20% of patients by 30 days. Patients in the study received optimal hydration, and the use of N-acetyl-cysteine was high, at 72%. These patients continue to represent a difficult cohort when undergoing angiography.
References:
Presented by Dr. Roxana Mehran at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2006), Washington, DC, October 2006.
Mehran R, Nikolsky E, Kirtane AJ, et al. Ionic low-osmolar versus nonionic iso-osmolar contrast media to obviate worsening nephropathy after angioplasty in chronic renal failure patients: the ICON (Ionic versus non-ionic Contrast to Obviate worsening Nephropathy after angioplasty in chronic renal failure patients) study. JACC Cardiovasc Interv. 2009 May;2(5):415-21.
Keywords: Triiodobenzoic Acids, Hyperlipidemias, Acute Kidney Injury, Coronary Disease, Creatinine, Angioplasty, Percutaneous Coronary Intervention, Contrast Media, Ioxaglic Acid, Renal Dialysis, Coronary Angiography, Hypertension, Diabetes Mellitus, Renal Insufficiency, Chronic
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