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

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. The properties of iodinated CM might...

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Veröffentlicht in:JACC. Cardiovascular interventions 2009-05, Vol.2 (5), p.415
Hauptverfasser: Mehran, Roxana, Nikolsky, Eugenia, Kirtane, Ajay J, Caixeta, Adriano, Wong, S Chiu, Teirstein, Paul S, Downey, William E, Batchelor, Wayne B, Casterella, Peter J, Kim, Young-Hak, Fahy, Martin, Dangas, George D
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container_issue 5
container_start_page 415
container_title JACC. Cardiovascular interventions
container_volume 2
creator Mehran, Roxana
Nikolsky, Eugenia
Kirtane, Ajay J
Caixeta, Adriano
Wong, S Chiu
Teirstein, Paul S
Downey, William E
Batchelor, Wayne B
Casterella, Peter J
Kim, Young-Hak
Fahy, Martin
Dangas, George D
description 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. The properties of iodinated CM might contribute to the incidence of contrast-induced nephropathy (CIN). Patients with renal impairment undergoing coronary angiography were randomly assigned to iodixanol (n = 72) or ioxaglate (n = 74). 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. 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.
doi_str_mv 10.1016/j.jcin.2009.03.007
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The properties of iodinated CM might contribute to the incidence of contrast-induced nephropathy (CIN). Patients with renal impairment undergoing coronary angiography were randomly assigned to iodixanol (n = 72) or ioxaglate (n = 74). 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 &gt;or=0.5 mg/dl (15.9% in iodixanol vs. 18.2% in ioxaglate), &gt;or=1.0 mg/dl (1.4% vs. 4.5%), and &gt;or=25% or &gt;or=0.5 mg/dl (15.9% vs. 24.2%, respectively) also did not differ significantly between the 2 groups. 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. 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Cardiovascular interventions</jtitle><addtitle>JACC Cardiovasc Interv</addtitle><date>2009-05</date><risdate>2009</risdate><volume>2</volume><issue>5</issue><spage>415</spage><pages>415-</pages><eissn>1876-7605</eissn><abstract>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. The properties of iodinated CM might contribute to the incidence of contrast-induced nephropathy (CIN). Patients with renal impairment undergoing coronary angiography were randomly assigned to iodixanol (n = 72) or ioxaglate (n = 74). 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 &gt;or=0.5 mg/dl (15.9% in iodixanol vs. 18.2% in ioxaglate), &gt;or=1.0 mg/dl (1.4% vs. 4.5%), and &gt;or=25% or &gt;or=0.5 mg/dl (15.9% vs. 24.2%, respectively) also did not differ significantly between the 2 groups. 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.</abstract><cop>United States</cop><pmid>19463464</pmid><doi>10.1016/j.jcin.2009.03.007</doi></addata></record>
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subjects Aged
Angioplasty, Balloon
Contrast Media - adverse effects
Coronary Angiography
Coronary Artery Disease - complications
Coronary Artery Disease - diagnosis
Creatinine
Double-Blind Method
Female
Humans
Ioxaglic Acid - adverse effects
Kidney Diseases - chemically induced
Kidney Failure, Chronic - physiopathology
Kidney Failure, Chronic - prevention & control
Male
Risk Assessment
Time Factors
Triiodobenzoic Acids - adverse effects
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
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