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J Am Coll Cardiol, 2006; 48:924-930, doi:10.1016/j.jacc.2006.06.047 (Published online 15 August 2006).
© 2006 by the American College of Cardiology Foundation
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CLINICAL RESEARCH: CLINICAL TRIAL

Renal Toxicity Evaluation and Comparison Between Visipaque (Iodixanol) and Hexabrix (Ioxaglate) in Patients With Renal Insufficiency Undergoing Coronary Angiography

The RECOVER Study: A Randomized Controlled Trial

Sang-Ho Jo, MD*,1, Tae-Jin Youn, MD*,1, Bon-Kwon Koo, MD*,*, Jin-Shik Park, MD*, Hyun-Jae Kang, MD*, Young-Seok Cho, MD*, Woo-Young Chung, MD*, Gwon-Wook Joo, MD{dagger}, In-Ho Chae, MD*, Dong-Ju Choi, MD*, Byung-Hee Oh, MD*, Myoung-Mook Lee, MD{ddagger}, Young-Bae Park, MD* and Hyo-Soo Kim, MD*,*

* Division of Cardiology, Department of Internal Medicine, Seoul National University College of Medicine/Cardiovascular Center, Seoul National University Hospital, Seoul, Korea
{dagger} Division of Nephrology, Department of Internal Medicine, Seoul National University College of Medicine/Cardiovascular Center, Seoul National University Hospital, Seoul, Korea
{ddagger} Cardiovascular Center, Dongguk University International Hospital, Goyang-si, Gyeonggi-do, Korea.

Manuscript received April 17, 2006; revised manuscript received June 1, 2006, accepted June 26, 2006.

* Reprint requests and correspondence: Dr. Hyo-Soo Kim or Dr. Bon-Kwon Koo, Department of Internal Medicine, Seoul National University College of Medicine, 28 Yongon-dong Jongno-gu, Seoul 110-744, Korea. (Email: hyosoo{at}snu.ac.kr).

OBJECTIVES: This study sought to compare the nephrotoxicity of iodixanol and ioxaglate in patients with renal impairment undergoing coronary angiography.

BACKGROUND: Iodixanol, a nonionic, dimeric, iso-osmolar contrast medium (IOCM), may be less nephrotoxic than low-osmolar contrast media (LOCM) in high-risk patients.

METHODS: In a prospective, randomized trial in 300 adults with creatinine clearance (CrCl) ≤60 ml/min, patients received either iodixanol or ioxaglate and underwent coronary angiography with or without percutaneous coronary intervention. The primary end point was the incidence of contrast-induced nephropathy (CIN) (an increase in serum creatinine [SCr] ≥25% or ≥0.5 mg/dl [≥44.2 µmol/l]). The incidence of CIN in patients with severe renal impairment at baseline (CrCl <30 ml/min) or diabetes and in those receiving large doses (≥140 ml) of contrast medium was also determined.

RESULTS: The incidence of CIN was significantly lower with iodixanol (7.9%) than with ioxaglate (17.0%; p = 0.021), corresponding to an odds ratio (OR) of CIN of 0.415 (95% confidence interval [CI] 0.194 to 0.889) for iodixanol. The incidence of CIN was also significantly lower with iodixanol in patients with severe renal impairment (p = 0.023) or concomitant diabetes (p = 0.041), or in patients given ≥140 ml of contrast media (p = 0.038). Multivariate analysis identified use of ioxaglate (OR 2.65, 95% CI 1.11 to 6.33, p = 0.028), baseline SCr, mg/dl (OR 2.0, 95% CI 1.04 to 3.85, p = 0.038), and left ventricular ejection fraction, % (OR 0.97, 95% CI 0.94 to 0.99, p = 0.019) as independent risk factors for CIN.

CONCLUSIONS: The IOCM iodixanol was significantly less nephrotoxic than ioxaglate, an ionic, dimeric LOCM. (The RECOVER Trial; http://clinicaltrials.gov; NCT00247325 [ClinicalTrials.gov] )

Abbreviations and Acronyms
  CI = confidence interval
  CIN = contrast-induced nephropathy
  CM = contrast medium
  CrCl = creatinine clearance
  HOCM = high-osmolar contrast medium
  IOCM = iso-osmolar contrast medium
  LOCM = low-osmolar contrast medium
  LVEF = left ventricular ejection fraction
  OR = odds ratio
  PCI = percutaneous coronary intervention
  SCr = serum creatinine




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