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J Am Coll Cardiol Intv, 2009; 2:415-421, doi:10.1016/j.jcin.2009.03.007
© 2009 by the American College of Cardiology Foundation
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Clinical Research

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

Roxana Mehran, MD*,{dagger},*, Eugenia Nikolsky, MD, PhD*,{dagger}, Ajay J. Kirtane, MD, SM*,{dagger}, Adriano Caixeta, MD, PhD*,{dagger}, S. Chiu Wong, MD{ddagger}, Paul S. Teirstein, MD§, William E. Downey, MD||, Wayne B. Batchelor, MD, MHS, Peter J. Casterella, MD#, Young-Hak Kim, MD, PhD*,{dagger}, Martin Fahy, MSc*,{dagger}, George D. Dangas, MD, PhD*,{dagger}

* Columbia University Medical Center, New York, New York
{dagger} Cardiovascular Research Foundation, New York, New York
{ddagger} Weill-Cornell Medical College, New York, New York
§ Scripps Clinic, San Diego, California
|| Moses Cone Heart and Vascular Center, Greensboro, North Carolina
St. Michaels Hospital, Toronto, Ontario, Canada
# LDS Hospital, Salt Lake City, Utah

* Reprint requests and correspondence: Dr. Roxana Mehran, Associate Professor of Medicine, Director, Outcomes Research, Data Coordination and Analysis, Center for Interventional Vascular Therapies, Columbia University Medical Center, Joint Chief Scientific Officer, Clinical Trial Center, Cardiovascular Research Foundation, New York, New York 10032 (Email: rmehran{at}crf.org).

Objectives: 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 ≥0.5 mg/dl (15.9% in iodixanol vs. 18.2% in ioxaglate), ≥1.0 mg/dl (1.4% vs. 4.5%), and ≥25% 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.

Key Words: angiography • contrast media • renal insufficiency

Abbreviations and Acronyms
  CIN = contrast-induced nephropathy
  CM = contrast media
  IOCM = iso-osmolar contrast media
  LOCM = low-osmolar contrast media




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