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J Am Coll Cardiol, 2007; 49:1669-1670, doi:10.1016/j.jacc.2007.02.004 © 2007 by the American College of Cardiology Foundation |
* Division of Cardiology, Department of Internal Medicine, Seoul National University, College of Medicine, Cardiovascular Center, 28 Yongon-dong Jongno-gu, Seoul 110-744, Korea (Email: hyosoo{at}snu.ac.kr).
Persson et al. (4) reported the finding of iodixanol inferiority contrary to that of the RECOVER study. However, the study by Persson et al. (4) was a retrospective study that had many compounding factors influencing results. The researchers did not present the basal serum creatinine and contrast dose of all patients, and the baseline characteristics of study groups were significantly different. Most importantly, previous renal failure, prior dialysis, ST-segment elevation myocardial infarction (STEMI), and unstable coronary diseases were more frequent in the iodixanol group, all of which were very critical determinants in developing contrast-induced nephropathy (CIN) and affecting clinical outcomes. We do not agree with Persson et al. (4) because of these critical limitations.
We showed a trend of lower CIN incidence in iodixanol by the more stringent criteria (serum creatinine increase 
0.5 mg/dl) as in the NEPHRIC (Nephrotoxicity in High-Risk Patients Study of Iso-Osmolar and Low-Osmolar Non-Ionic Contrast Media) (5) despite failure to reach statistical significance (3.6% vs. 8.9%, p = 0.067). We disagree with the view of Dr. Persson and colleagues that iso-osmolar contrast media had no beneficial effect over low-osmolar contrast media owing to a p value of 0.067. Other investigations support the superiority of iodixanol, such as Chalmers’ study, the NEPHRIC study, and recent meta-analyses (6,7).
Regarding the different sample size, only preliminary data of the RECOVER study were shown in scientific meetings, and registry data collected during the same period that the RECOVER study was conducted were erroneously incorporated into randomization data. Therefore, the iodixanol group was asymmetrically larger, and total patient population was higher in abstracts of scientific meetings.
We agree with Dr. Deray’s comment that it would be better to present both intention-to-treat and per-protocol analyses. However, many investigators presented their data only by per-protocol analysis (8). Moreover, both analyses made no differences in the RECOVER trial.
We already addressed the issues regarding different age and similar clinical outcomes of our study. Some studies reported age over 75 as the risk factor of CIN (9). In the RECOVER study, the mean age of both groups was under 75 years, and the proportion of patients over 75 was 18% in the iodixanol group and 22% in the ioxaglate group, with no difference (p = 0.451). We do not believe that the age difference influenced our results.
Finally, all patients in the RECOVER study received adequate periprocedural hydration, and the body weight was similar in the 2 groups, as depicted in the study. Although the exact level of hydration was only available in some patients, volume status was evaluated by both physical examination and laboratory test in all patients. Thereafter, dehydrated and acute renal-failure patients were excluded.
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