Ionic Versus Nonionic Contrast to Obviate Worsening Nephropathy After Angioplasty in Chronic Renal Failure Patients - ICON
The goal of the trial was to compare ionic versus nonionic contrast among patients with chronic renal insufficiency undergoing coronary angiography.
Patients Enrolled: 145
Mean Follow Up: 30 days
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
Peak increase in creatinine concentration from day 0 to day 3
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.
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).
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.
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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