Iobitridol 768mg/ml (Iodine 350mg/ml) infusion 100ml bags

OBJECTIVES: To demonstrate non-inferiority of iobitridol 350 for coronary CT angiography (CTA) compared to higher iodine content contrast media regarding rate of patients evaluable for the presence of coronary artery stenoses. METHODS: In this multicentre trial, 452 patients were randomized to receive iobitridol 350, iopromide 370 or iomeprol 400 and underwent coronary CTA using CT systems with 64-detector rows or more. Two core lab readers assessed 18 coronary segments per patient regarding image quality (score 0 = non diagnostic to 4 = excellent quality), vascular attenuation, signal and contrast to noise ratio (SNR, CNR). Patients were considered evaluable if no segment had a score of 0. RESULTS: Per-patient, the rate of fully evaluable CT scans was 92.1, 95.4 and 94.6 % for iobitridol, iopromide and iomeprol, respectively. Non-inferiority of iobitridol over the best comparator was demonstrated with a 95 % CI of the difference of [-8.8 to 2.1], with a pre-specified non-inferiority margin of -10 %. Although average attenuation increased with higher iodine concentrations, average SNR and CNR did not differ between groups. CONCLUSIONS: With current CT technology, iobitridol 350 mg iodine/ml is not inferior to contrast media with higher iodine concentrations in terms of image quality for coronary stenosis assessment. KEY POINTS: • Iodine concentration is an important parameter for image quality in coronary CTA. • Contrast enhancement must be balanced against the amount of iodine injected. • Iobitridol 350 is non-inferior compared to CM with higher iodine concentrations. • Higher attenuation with higher iodine concentrations, but no SNR or CNR differences.

Abstract licence: CC BY 4.0

To study the effect of non-ionic contrast media on anticoagulated and non-anticoagulated human whole blood samples, calorimetric measurements were performed. The anticoagulated plasma showed the greatest fall in the total ΔH after Iodixanol treatment. The plasma-free erythrocytes revealed a pronounced shift in the Tmax and a decrease in the ΔH of hemoglobin and transferrin. The total ΔH of Iodixanol treatment showed the highest decline, while Iomeprol and Iobitridol had fewer adverse effects. Similarly, the non-anticoagulated samples revealed a decrease both in the Tmax and the ΔH of albumin and immunoglobulin-specific transitions. The total ΔH showed that Iodixanol had more influence on the serum. The serum-free erythrocyte samples resulted in a significant drop in the Tmax of erythrocyte and transferrin (~5–6 °C). The ΔH of deconvolved hemoglobin and transferrin decreased considerably; however, the ΔH of albumin increased. Surprisingly, compared to Iomeprol and Iobitridol treatments, the total ΔH of Iodixanol was less pronounced in the non-anticoagulated erythrocyte samples. In sum, each non-ionic contrast medium affected the thermal stability of anticoagulated and non-anticoagulated erythrocyte proteins. Interestingly, Iodixanol treatment caused more significant effects. These findings suggest that conformational changes in blood components can occur, which can potentially lead to the increased prevalence of cardiovascular dysfunctions and blood clotting.

Abstract licence: CC BY 4.0

BackgroundAlthough the pathogenesis of acute kidney injury (AKI) in patients with acute coronary syndrome (ACS) undergoing invasive treatment is multifactorial, the role of iodinated contrast media (CM) has been well established. The DyeVert system (Osprey Medical) is designed to reduce the CM volume during invasive coronary procedures while maintaining fluoroscopic image quality.ObjectiveThe aim of the Renal Insufficiency Following Contrast Media Administration Trial IV (REMEDIAL IV) is to test whether the use of the DyeVert system is effective in reducing contrast-associated acute kidney injury (CA-AKI) rate in patients with ACS undergoing urgent invasive procedures.Trial designPatients with ACS treated by urgent invasive approach will be enrolled. Participants will be randomly assigned into one of the following groups: (1) DyeVert group and (2) control group. In participants enrolled in the DyeVert group, CM injection will be handled by the DyeVert system. On the contrary, in the control group, CM injection will be performed by a conventional manual or automatic injection syringe. In all cases, iobitridol (a low-osmolar, nonionic CM) will be administered. Participants will receive intravenous 0.9% sodium chloride as soon as moved to the catheterization laboratory. The primary end points are CM volume administration and CA-AKI rate (ie, an increase in serum creatinine concentration of ≥0.3 mg/dL within 48 hours after CM exposure). A sample size of at least 522 randomized participants (261 in each group) is needed to demonstrate an 8.5% difference in the CA-AKI rate between the groups (that is, from 19% in the control group to 10.5% in the DyeVert group), with a 2-sided 95% confidence interval and 80% power (P < .05).

Abstract licence: CC BY