CORRESPONDENCE: LETTER TO THE EDITOR
Evaluation and Comparison Between Visipaque (Iodixanol) and Hexabrix (Ioxaglate) in Coronary Angiography
Pontus Persson, MD*,
Per Liss, MD and
Peter Hansell, MD
* Humboldt-Universität zu Berlin, Institute of Vegetative Physiology, Tucholskystrasse 2, Berlin D-10117, Germany (Email: pontus.persson{at}charite.de).
We read with interest the report by Jo et al. (1). The reported head-to-head study (RECOVER [Renal Toxicity Evaluation and Comparison Between Visipaque and Hexabrix in Patients With Renal Insufficiency Undergoing Coronary Angiography]) compares the renal tolerance of the iso-osmolar contrast medium (CM) iodixanol to the low-osmolar CM ioxaglate using established surrogate definitions for contrast-induced nephropathy (CIN). Jo et al. (1) believe the results of the RECOVER study support the conclusions of the NEPHRIC (Nephrotoxic Effects in High-Risk Patients Undergoing Angiography) study (2), which created the hypothesis that iso-osmolar CM are superior regarding CIN as compared to the well-established low-osmolar contrast media (LOCM). To date, the NEPHRIC study was never confirmed in a larger series, a fact that has increasingly raised concerns (3).
The results of RECOVER are in complete disagreement with the results of our recent registry analysis in over 57,000 patients (4). The latter study clearly demonstrates a higher incidence of actual renal failure after iodixanol application as compared to ioxaglate or iohexol application. We note that the RECOVER study includes more patients (n = 275) than the NEPHRIC study (n = 129), but taking the reported figures of the RECOVER study at face value one cannot fail to notice some inconsistencies in the results. The broad surrogate definition of CIN, 25% relative or 0.5 mg/dl increase over baseline, reaches significance in the RECOVER study (p = 0.021); however, the 2 more stringent surrogate definitions that were used in the NEPHRIC study (0.5 mg/dl; 1.0 mg/dl increase over baseline) both did not reach significance. Thus, in terms of statistical significance the RECOVER study does not confirm the NEPHRIC study (i.e., no beneficial effect of iso-osmolar CM over LOCM). Regarding outcome end points, the RECOVER study actually shows no, let alone significant, differences between the agents. Acute renal failure requiring dialysis occurred only once in both the iodixanol and the ioxaglate groups. One can argue that the more stringent/relevant the end points the less or even nonexistent are the differences between the 2 groups in the RECOVER study. Still, the RECOVER study results seem to contradict the findings of our registry study, as the outcome end points showed no differences between the agents. However, the size of the RECOVER study with 275 patients is much too small to detect differences between the rarely occurring outcome events.
Our registry study, conversely, included over 57,000 patients, a size adequate to detect such small differences in an important end point as acute renal failure. Finally, we notice a discrepancy between the patient numbers in the groups published in a previous abstract on the RECOVER study (5) where the iodixanol group had some 20 patients more and the ioxaglate group had some 20 patients less, which may interfere with the investigators’ analysis.
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1. Jo SH, Youn TJ, Koo BK, et al. 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 J Am Coll Cardiol 2006;48:924-930.[Abstract/Free Full Text]2. Aspelin P, Aubry P, Fransson SG, et al. Nephrotoxic effects in high-risk patients undergoing angiography N Engl J Med 2003;348:491-499.[Abstract/Free Full Text] 3. Thomsen HS, Morcos SK. Contrast-medium-induced nephropathy: is there a new consensus?A review of published guidelines. Eur Radiol 2006;16:1835-1840.[CrossRef][Web of Science][Medline] 4. Liss P, Persson PB, Hansell P, et al. Renal failure in 57,925 patients undergoing coronary procedures using iso-osmolar or low-osmolar contrast media Kidney Int 2006;70:1811-1817.[CrossRef][Web of Science][Medline] 5. Jo SH, Youn TJ, Park JS, et al. Iodixanol is less nephrotoxic than ioxaglate in patients with renal insufficiency after coronary angiography J Am Coll Cardiol 2005;45(Suppl A):32A.
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