Consensus Report from Oncology Advisory Board Meeting

22 • Strategies for Prevention and Management of CI-AKI and the Role of Contrast in Oncology CT Settings that if iodixanol is used in such patients, the rate of AKI is not prohibitively high to preclude this group from receiving diagnostic imaging, if clinically required. Aprospective randomized, double-blind trial investigated the effects of IV administration of IOCM (iodixanol, n = 61) vs LOCM (iopromide, n = 56) on renal functions in high-risk patients undergoing IV CECT; renal functions were assessed in terms of change in serum Cr and GFR [3]. The high-risk study patients had decreased renal function at baseline. The use of measures to protect the kidney (e.g. hydration and prophylactic treatments) was at the discretion of the referring clinician requesting the scan. Outcome measures were serum Cr increase or GFR decrease for 3 days after CT, a serum Cr increase (of ≥0.5 mg/dL [25%] or ≥1.0 mg/dL [50%]), a GFR reduction (of ≥5 mL/min), and patient outcome at 30- and 90-day follow-up. AKI was defined as ≥25% or 0.5 mg/dl increase in serum Cr from baseline. Even though iodixanol group included higher proportion of patients with diabetes and hypertension than iopromide group, the rate of AKI was lower in iodixanol group than iopromide group (Fig. 3). Another interesting observation was that serum Cr levels decreased within 24 hours of iodixanol use, whereas they increased over the same period following iopromide use. It was concluded that IV CM use even in high-risk patients is unlikely to be associated with permanent adverse outcomes. Furthermore, use of iodixanol produces significantly less rise in serum Cr levels than iopromide use. More recently, a randomized controlled trial assessed the safety profile of IOCM versus LOCM in cancer patients at very low risk of AKI (eGFR of > 60 ml/min), undergoing CECT [4]. This study was prospective, multicentre, double- blind, and randomized in patients with a clinical indication for CT. Out of total 497 patients who were eligible for the study, 247 were randomized to iodixanol (IOCM) and 250 to iopromide (LOCM). Primary outcomes were development of CI-AKI at 24 and/or 72 hours. Other outcomes assessed were irreversible CI-AKI, average eGFR percentage variation (%Δ), and adverse events. Seven and three CI-AKI at 24 hr (p= 0.34) and 8 and 2 CIN at 72 hr (p= 0.11) occurred in the iopromide and iodixanol groups, respectively (Fig. 4). Within the subgroup of individual patients who developed CI-AKI (N: 17), the event rate was higher in the iopromide arm (p = 0.045; Fig. 4). No cases of permanent CI-AKI or significant differences in terms of AEs or GFR %Δ were observed. Favourable safety profile of iodixanol was reflected by comparative lower rate of CI-AKI in iodixanol group than iopromide group (p= 0.045). Safety and Tolerability of Iodixanol in Clinical Settings Tangible evidence shows IOCM iodixanol to have favourable safety profile as compared with LOCM iopromide when administered intra-arterially. Patients with cancer often experience severe pain and heat sensations because of chemotherapy or CM on their venous integrity. Therefore, it is important to assess the safety profile of IV administration of CM in these patients. Weiland, et al. in a prospective, randomized, double-blind, multicenter study sought to evaluate and compare the frequency and intensity of patient Fig. 2. Risk of AKI with iodixanol in high-risk patients. AKI: acute kidney injury (increase in SCr ≥25% or ≥0.5 mg/dl from baseline) SCr: serum creatinine Source: [2] Fig. 3. Risk of AKI with iodixanol vs iopromide in high-risk patients. AKI: acute kidney injury; SCr: serum creatinine Source: [3] JB6810 01-2016AKI in cancerpatients Risk of AKI with iodixanol in high-risk patients 9% 5% 3% 5% 3% 1% 0 20 40 60 80 100 Iodixanol: elevated baseline SCr (n=189) Iodixanol: patients at high risk of CIN but normal baseline SCr (n=185) Iohexol: patients at low risk of CIN and normal baseline SCr (n=194) Patients with AKI, % AKI Irreversible AKI Cheruvu B et al. J Comput Assist Tomogr 2007; 31 : 493 – 8. AKI: acute kidney injury (increase in SCr ≥25% or ≥0.5 mg/dl from baseline) SCr: serum creatinine JB6810 01-2016AKI in cancerpatients Risk of AKI with iodixanol vs iopromide in high-risk patients 18.5 27.8 5.1 8.5 0 20 40 60 80 100 SCr increase ≥0.5 mg/dl SCr increase ≥25% from baseline Patients with AKI, % Iopromide Iodixanol Nguyen SA et al. Radiology 2008; 248 : 97 – 105. AKI: acute kidney injury SCr: serum creatinine p=0.037 p=0.012