Original Article
Renal effects of contrast media in diabetic patients undergoing diagnostic or interventional coronary angiography

https://doi.org/10.1016/j.jdiacomp.2006.11.002Get rights and content

Abstract

Background

The use of safe iodinated contrast media (CM) to prevent contrast-induced nephropathy (CIN) is an important consideration among renally impaired diabetic patients during coronary angiography.

Hypothesis

Diabetic patients with normal or mild renal dysfunction are less likely to receive renal protective measures during angiography, yet they may also be at risk for CIN. We compared the renal effects of iopamidol and iodixanol in diabetic patients who were referred for angiography.

Methods

Diabetic patients (N=122) with a serum creatinine (SCr) level of ≤2 mg/dl were double-blind randomized to receive nonionic CM: iopamidol-370 (low osmolar, monomeric) or iodixanol-320 (iso-osmolar, dimeric). Renal stability was evaluated at baseline and at Days 1, 3, and 7 postangiography. The primary endpoint was a ≥25% increase in SCr.

Results

Seventeen (10 iopamidol, 7 iodixanol; P=NS) patients had an increase in SCr ≥25% over baseline. Over all days, analysis revealed nonsignificant differences in the incidence of CIN between the two study groups regardless of how CIN was defined.

Conclusions

Diabetic patients with normal or mild renal dysfunction are at risk for CIN. No significant difference in renal response was observed for these CM in this at-risk population.

Introduction

Coronary artery disease is a major complication of diabetes mellitus. The use of safe, effective contrast media (CM) is important as the frequency of cardiac diagnostic and interventional procedures escalates, particularly among populations at risk for developing contrast-induced nephropathy (CIN). The increased risk of CIN in diabetic patients with reduced renal function is well documented (Barrett & Carlisle, 1993, Parfrey et al., 1989, Rudnick et al., 1995, Rudnick et al., 1995). Yet, diabetic patients without overt renal dysfunction are also at risk, as compromised renal function may not manifest until an acute renal insult results from the administration of CM (Burns, 2000, McCullough et al., 1997, Parfrey et al., 1989, Pflueger et al., 2000, Weisberg et al., 1994). Early studies demonstrated a partial CIN risk reduction by lowering CM osmolality (Barrett & Carlisle, 1993, Barrett et al., 1992, Katholi et al., 1993, Rudnick et al., 1995, Rudnick et al., 1995), which led researchers to evaluate the possible benefits of iso-osmolar CM (Carraro et al., 1998, Chalmers & Jackson, 1999, Deray et al., 1999, Grynne et al., 1995, Jakobsen, 1995, Jakobsen et al., 1996, Jakobsen et al., 1992, Laissy et al., 2000, Lancelot et al., 1999, Lancelot et al., 2002, Lee et al., 1996, Walday et al., 1995). As individual CM have specific effects on renal cells (Hardiek, Katholi, Ramkumar, & Deitrick, 2001), head-to-head studies are needed to compare the safer CM in at-risk patients undergoing angiography. Since our in vitro proximal renal tubular cell studies suggested that iopamidol and iodixanol are the least nephrotoxic molecules (Hardiek et al., 2001), we compared these CM in diabetic patients with normal or mild renal dysfunction, who are less likely to receive renal protective measures.

Section snippets

Methods

Between July 2001 and October 2002, eligible patients referred to the cardiac catheterization laboratory for diagnostic or interventional angiography were enrolled in this study. Eligible patients were ≥18 years of age with a history of diabetes and with a serum creatinine (SCr) level of ≤2 mg/dl. Exclusion criteria included hypersensitivity to iodine or CM, urinary obstruction or evidence of dehydration, dialysis, pregnancy, and administration of CM (within 72 h) or theophylline or N

Results

Of the 56 patients randomized to the iopamidol group, 4 never received the CM, while another 4 patients did not complete the follow-up phase of the study, leaving a total of 48 evaluable patients. Of the 66 patients randomized to the iodixanol group, 3 patients did not receive CM and 9 failed to complete follow-up, resulting in 54 evaluable patients. As shown in Table 1, baseline demographics (age, sex, and body mass index), baseline clinical parameters (SCr and CrCl), and procedural

Discussion

Our findings indicate that severe renal dysfunction need not be present to create a risk of CIN in patients with diabetes mellitus. We also found that the renal effects of these safer molecules, iopamidol and iodixanol, were comparable in this moderate-risk diabetic population. While this head-to-head trial was designed and carried out with the hope of being able to reject the null hypothesis and demonstrate a difference between CM, findings regarding the absence of significant differences in

Limitations

The study sample of this head-to-head, randomized, double-blinded comparison of iopamidol versus iodixanol, while similar in size to the NEPHRIC study, is relatively small. At the time this study was designed, there were little data available concerning the likely prevalence of CIN in diabetic patients with normal or mild renal dysfunction. Sample sizes chosen were thought adequate for comparing changes in renal function over time between the two groups by means of repeated-measures ANOVA. A

Conclusions and practical applications

The renal effects of iopamidol and iodixanol were comparable in this moderate-risk diabetic population. Our findings indicate that severe renal dysfunction need not be present to create a risk of CIN in diabetic patients. Moreover, pharmacological prevention therapies, which are not routinely utilized on this moderate-risk population due to their apparently normal or mild renal dysfunction, should be considered since many of these patients will likely require an intervention after diagnostic

Acknowledgment

This original research study was funded by a grant provided by Bracco Diagnostics, Inc.

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