title: 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.
abstract: OBJECTIVE
  This randomized, prospective, double-blind, multicenter study compared nephrotoxicity of the nonionic iso-osmolar contrast media (CM) iodixanol versus the ionic low-osmolar CM ioxaglate in patients with chronic renal insufficiency undergoing coronary angiography.
  
  
  BACKGROUND
  The properties of iodinated CM might contribute to the incidence of contrast-induced nephropathy (CIN).
  
  
  METHODS
  Patients with renal impairment undergoing coronary angiography were randomly assigned to iodixanol (n = 72) or ioxaglate (n = 74).
  
  
  RESULTS
  Baseline characteristics were well-matched between the 2 groups. The predicted risk score for CIN was similar in the iodixanol and in the ioxaglate groups (11.9 +/- 4.1 vs. 11.8 +/- 4.1), as was the use of N-acetylcysteine (70% vs. 73%). The primary end point of the study, median peak increase of serum creatinine from day 0 through day 3 after angiography, did not differ between the iodixanol (0.09 mg/dl; interquartile range 0.00 to 0.30 mg/dl) and the ioxaglate (0.15 mg/dl; interquartile range 0.00 to 0.40 mg/dl; p = 0.07) groups. The percentages of patients with a peak increase of serum creatinine >or=0.5 mg/dl (15.9% in iodixanol vs. 18.2% in ioxaglate), >or=1.0 mg/dl (1.4% vs. 4.5%), and >or=25% or >or=0.5 mg/dl (15.9% vs. 24.2%, respectively) also did not differ significantly between the 2 groups.
  
  
  CONCLUSIONS
  In high-risk patients undergoing coronary angiographic procedures, use of the nonionic iso-osmolar CM iodixanol does not reduce renal deterioration in patients with renal impairment, compared with the ionic low-osmolar CM ioxaglate. Given that the study was underpowered to compare nephrotoxicity of the 2 groups under the active medical protection of CIN, a larger randomized study is warranted that will enroll patients with higher risks of CIN under a strict control of hydration regimens and adjunctive medications.
authors.affiliation: Center for Interventional Vascular Therapies, Columbia University Medical Center, New York, New York 10032, USA. rmehran@crf.org
authors.forename: Roxana
authors.initials: R
authors.lastname: Mehran
authors.forename: Eugenia
authors.initials: E
authors.lastname: Nikolsky
authors.forename: Ajay J
authors.initials: AJ
authors.lastname: Kirtane
authors.forename: Adriano
authors.initials: A
authors.lastname: Caixeta
authors.forename: S Chiu
authors.initials: SC
authors.lastname: Wong
authors.forename: Paul S
authors.initials: PS
authors.lastname: Teirstein
authors.forename: William E
authors.initials: WE
authors.lastname: Downey
authors.forename: Wayne B
authors.initials: WB
authors.lastname: Batchelor
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Casterella
authors.forename: Young-Hak
authors.initials: YH
authors.lastname: Kim
authors.forename: Martin
authors.initials: M
authors.lastname: Fahy
authors.forename: George D
authors.initials: GD
authors.lastname: Dangas
mesh_terms: D000368:Aged; D000800:Angioplasty, Balloon; D003287:Contrast Media / Q000009:adverse effects*; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000150:complications / Q000175:diagnosis*; D003404:Creatinine; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007485:Ioxaglic Acid / Q000009:adverse effects; D007674:Kidney Diseases / Q000139:chemically induced; D007676:Kidney Failure, Chronic / Q000503:physiopathology / Q000517:prevention & control*; D008297:Male; D018570:Risk Assessment; D013997:Time Factors; D014283:Triiodobenzoic Acids / Q000009:adverse effects
chemical_list: D003287:Contrast Media; D014283:Triiodobenzoic Acids; D003404:Creatinine; C044834:iodixanol; D007485:Ioxaglic Acid