Author + information
- Received August 18, 2008
- Revision received March 10, 2009
- Accepted March 19, 2009
- Published online May 1, 2009.
- Roxana Mehran, MD⁎,†,⁎ (, )
- Eugenia Nikolsky, MD, PhD⁎,†,
- Ajay J. Kirtane, MD, SM⁎,†,
- Adriano Caixeta, MD, PhD⁎,†,
- S. Chiu Wong, MD‡,
- Paul S. Teirstein, MD§,
- William E. Downey, MD∥,
- Wayne B. Batchelor, MD, MHS¶,
- Peter J. Casterella, MD#,
- Young-Hak Kim, MD, PhD⁎,†,
- Martin Fahy, MSc⁎,† and
- George D. Dangas, MD, PhD⁎,†
- ↵⁎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
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.
This study was supported by a research grant from Tyco Healthcare/Mallinckrodt, Inc. (St. Louis, Missouri) and Guerbet Group (Paris, France). Dr. Mehran is a consultant for Guerbet.
- Received August 18, 2008.
- Revision received March 10, 2009.
- Accepted March 19, 2009.
- American College of Cardiology Foundation