Evaluation and comparison between visipaque (iodixanol) and hexabrix (ioxaglate) in coronary angiography
2007 (English)In: Journal of the American College of Cardiology, ISSN 0735-1097, E-ISSN 1558-3597, Vol. 49, no 15, 1668-1669 p.Article in journal (Refereed) Published
We read with interest the report by Jo et al. (1). The reportedhead-to-head study (RECOVER [Renal Toxicity Evaluation and ComparisonBetween Visipaque and Hexabrix in Patients With Renal InsufficiencyUndergoing Coronary Angiography]) compares the renal toleranceof the iso-osmolar contrast medium (CM) iodixanol to the low-osmolarCM ioxaglate using established surrogate definitions for contrast-inducednephropathy (CIN). Jo et al. (1) believe the results of theRECOVER study support the conclusions of the NEPHRIC (NephrotoxicEffects in High-Risk Patients Undergoing Angiography) study(2), which created the hypothesis that iso-osmolar CM are superiorregarding CIN as compared to the well-established low-osmolarcontrast media (LOCM). To date, the NEPHRIC study was neverconfirmed in a larger series, a fact that has increasingly raisedconcerns (3).
The results of RECOVER are in complete disagreement with theresults of our recent registry analysis in over 57,000 patients(4). The latter study clearly demonstrates a higher incidenceof actual renal failure after iodixanol application as comparedto ioxaglate or iohexol application. We note that the RECOVERstudy includes more patients (n = 275) than the NEPHRIC study(n = 129), but taking the reported figures of the RECOVER studyat face value one cannot fail to notice some inconsistenciesin the results. The broad surrogate definition of CIN, 25% relativeor 0.5 mg/dl increase over baseline, reaches significance inthe RECOVER study (p = 0.021); however, the 2 more stringentsurrogate definitions that were used in the NEPHRIC study (0.5mg/dl; 1.0 mg/dl increase over baseline) both did not reachsignificance. Thus, in terms of statistical significance theRECOVER study does not confirm the NEPHRIC study (i.e., no beneficialeffect 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 requiringdialysis occurred only once in both the iodixanol and the ioxaglategroups. One can argue that the more stringent/relevant the endpoints the less or even nonexistent are the differences betweenthe 2 groups in the RECOVER study. Still, the RECOVER studyresults seem to contradict the findings of our registry study,as the outcome end points showed no differences between theagents. However, the size of the RECOVER study with 275 patientsis much too small to detect differences between the rarely occurringoutcome events.
Our registry study, conversely, included over 57,000 patients,a size adequate to detect such small differences in an importantend point as acute renal failure. Finally, we notice a discrepancybetween the patient numbers in the groups published in a previousabstract on the RECOVER study (5) where the iodixanol grouphad some 20 patients more and the ioxaglate group had some 20patients less, which may interfere with the investigators’analysis.
Place, publisher, year, edition, pages
2007. Vol. 49, no 15, 1668-1669 p.
Contrast Media/adverse effects, Coronary Angiography/adverse effects/methods, Coronary Disease/complications/*radiography, Humans, Ioxaglic Acid/*adverse effects/diagnostic use, Kidney Failure; Acute/*chemically induced, Prognosis, Registries, Renal Insufficiency; Chronic/*complications, Risk Assessment, Triiodobenzoic Acids/*adverse effects/diagnostic use
Medical and Health Sciences
IdentifiersURN: urn:nbn:se:uu:diva-17208DOI: 10.1016/j.jacc.2007.02.006PubMedID: 17433962OAI: oai:DiVA.org:uu-17208DiVA: diva2:44979