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Comparison of the Diagnostic Efficacy of Iobitridol 350 M

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Comparison of the Diagnostic Efficacy of Iobitridol 350 M Eur Radiol (2010) 20: 572–583 DOI 10.1007/s00330-009-1600-6 COMPUTED TOMOGRAPHY Christian Loewe 64-Slice CT angiography of the abdominal Christoph R. Becker Riccardo Berletti aorta and abdominal arteries: comparison Carlo Alberto Cametti Jerome Caudron of the diagnostic efficacy of iobitridol Walter Coudyzer Johan De Mey 350 mgI/ml versus iomeprol 400 mgI/ml Massimo Favat in a prospective, randomised, double-blind Jean-François Heautot Sam Heye multi-centre trial Markus Hittinger Antoine Larralde Jean-Pierre Lestrat Roberto Marangoni Koenraad Nieboer Peter Reimer Martin Schwarz Melanie Schernthaner Johannes Lammer Received: 27 March 2009 J. Caudron . J.-P. Lestrat own technique for delivery of contrast Accepted: 13 August 2009 Department of Radiology, medium, regardless of iodine con- Published online: 30 September 2009 University Hospital of Rouen, centration. Diagnostic efficacy, image # The Author(s) 2009. Rouen, France quality, visualisation of the arterial This article is published with open access at . wall and arterial enhancement were Springerlink.com W. Coudyzer S. Heye Department of Radiology, UZ Leuven, evaluated. A total of 153 patients Leuven, Belgium received iobitridol and 154 received . iomeprol. Results: The ability to J. De Mey K. Nieboer reach a diagnosis was “satisfactory” to This paper was presented as a scientific Department of Radiology, UZ Brussel, “ ” paper at ECR 2009. Brussels, Belgium totally satisfactory in 152 (99.3%) and 153 (99.4%) patients respectively. This clinical trial was supported by Guerbet, J.-F. Heautot . A. Larralde Image quality was rated as being Roissy, France. Department of Radiology, “ ” “ ” Pontchaillou Hospital, good to excellent in 94.7 and C. Loewe (*) . M. Schernthaner . Rennes, France 94.8% segments respectively. Similar J. Lammer results were observed for image qual- Section of Cardiovascular P. Reimer . M. Schwarz ity of arterial walls (84.3 vs. 83.2%). and Interventional Radiology, Department of Radiology, Städt. The mean relative changes in arterial Department of Radiology, Klinikum Karlsruhe, Medical University Vienna, Karlsruhe, Germany enhancement between baseline and Waehringer Guertel 18-20, arterial phase images showed no 1090 Vienna, Austria statistically significant differences. e-mail: christian.loewe@meduniwien. Abstract Purpose: The purpose of Conclusion: This study demonstrated ac.at this study was to assess the influence the non-inferiority of the 350 versus of iodine concentration on diagnostic C. R. Becker . M. Hittinger 400 mgI/ml iodine concentration, in Department of Clinical Radiology, efficacy in multi-detector-row com- terms of diagnostic efficacy, in ab- University Hospital Grosshadern, puted tomography (MDCT) angiog- dominal MDCT angiography. It also Munich, Germany raphy of the abdominal aorta and confirmed the high robustness and abdominal arteries. Methods: IRB R. Berletti . M. Favat reliability of this technique across Department of Radiology, approval and informed consent were multi-national practices. Belluno Civil Hospital, obtained. In this double-blind trial, Belluno, Italy patients were randomised to undergo . MDCT angiography of the abdominal Keywords CT angiography C. A. Cametti R. Marangoni arteries during administration of io- Abdominal arterial tree . Department of Radiology, . ASL TO2 Ospedale San G. Bosco, bitridol (350 mgI/ml) or iomeprol Diagnostic efficacy Iodinated Torino, Italy (400 mgI/ml). Each centre applied its contrast agents 573 Introduction used. In addition, the various centres participating in the present trial were to use their own injection protocols. A Multi-detector-row computed tomography (MDCT) has lack of relevant differences in diagnostic efficacy, image been established as the method of choice for the diagnosis, quality and arterial contrast enhancement among the treatment planning and follow-up of most diseases of the centres will emphasise how stable and easy to perform abdominal arteries, including the renal [1–4] and visceral abdominal CT angiography is in clinical settings if state-of- arteries [5, 6] and the aorta [7–9]. In these anatomical the-art equipment is used. regions, diagnostic invasive arteriography (digital subtrac- The aim of this prospective, randomised study was, tion angiography, DSA) has steadily been replaced over the therefore, to assess the influence of iodine concentration on past few years by non-invasive CT angiography and, in diagnostic efficacy in CT angiography of the abdominal some cases, by non-invasive magnetic resonance (MR) and visceral arteries. angiography [10–12]. However, the broad use of MDCT in the clinical routine, as well as the choice of contrast agent and administration Materials and methods technique thereof, still remains controversial. Many authors have shown that the enhancement of the abdominal Study design and patient enrolment conditions arteries is directly correlated to the amount of iodine (not contrast agent) per second [5, 13], also known as the This study was a non-inferiority, randomised, double-blind, “iodine flux”. The higher the iodine flux, the higher the prospective, multi-centre trial in patients referred for CT density will be within the region of interest. On the other angiography of the abdominal aorta and its branches. Nine hand, increasing the total amount of iodine could raise European centres were involved in this trial between safety issues such as concern of contrast-induced neph- August 2006 and February 2008. The study protocol was ropathy (CIN) in at-risk patients. Because a lower total approved by the local Ethics Committees and Competent amount of iodine lowers the risk of CIN [14–16], protocols Authorities. for CT angiography should always find a compromise As this study was designed to reflect the conditions of between the required contrast enhancement and the amount daily routine, patients were included in a consecutive of iodine injected. manner, regardless of the indication for the examination. Although many papers have been published about Patients between 18 and 85 years of age were eligible for preferred methods of administering contrast medium, study participation. A history of previous (open surgical or some questions remain unanswered. It is still unclear as endovascular) vascular treatment in the abdomen was not to what degree of vascular opacification (in Hounsfield an exclusion criterion. Patients with haemodynamic units, HU) is really necessary to obtain diagnostic images; instability, non-compensated heart failure or hypertension in other words, does higher density, which can possibly be (systolic blood pressure ≥180 mmHg or diastolic blood reached with more highly concentrated agents and higher pressure ≥110 mmHg) were not included. In addition, iodine flux, really further improve diagnostic accuracy? patients with severe renal insufficiency [defined as Finally, even injection parameters still need to be estimated creatinine clearance (Cockroft and Gault) standardised. Fleischmann and Hittmair [5, 17–19] have below 30 ml/min], treatment with diuretics or biguanides shown the advantages of using a biphasic contrast injec- within 48 h before CT angiography, known thyrotoxicosis tion, calculated individually for every patient, in CT or a history of hypersensitivity to iodinated contrast agents angiography of the abdominal aorta. However, these were not included. Breast-feeding or pregnant women were studies were performed on single-slice systems with long also excluded from participation in this trial. acquisition times. With fast imaging, using 64-slice CT After providing written, informed consent, patients were systems, it seems that injection protocols could be made randomised into two examination groups according to a much easier, and the benefit of a contrast medium with randomisation list stratified on centres and balanced every higher iodine concentrations could be of great importance. four patients. Patients in the first group were to undergo the In addition, optimum injection rate, optimum iodine abdominal CT angiography with injection of iobitridol concentration and optimum total volume of contrast 350 mgI/ml (Xenetix®, Guerbet, Roissy, France); patients medium for abdominal CT angiography still need to be in the second group were to be examined by means of CT determined. angiography with injection of iomeprol 400 mgI/ml In the present trial, patients were investigated during the (Iomeron®, Bracco, Italy). injection of two different contrast agents with different iodine concentrations (350 vs. 400 mgI/ml). In contrast to some recently published papers [20], where patients were CT angiography examined with different iodine concentrations but constant iodine flux rates, the injection protocol in the present study All patients included in the present evaluation were scheduled was not adapted to the iodine concentration of the agent to undergo CT angiography of the abdominal aorta and 574 abdominal arteries. All examinations were performed on 64- Evaluation slice single-source CT systems (two Siemens SOMATOM Sensation, four General Electrics LightSpeed VCT, two All CT images were assessed on-site by one local Philips Brillance 64), and on a dual-source Siemens investigator at each participating hospital. The investigator SOMATOM Definition used as a single-source. was blinded to the contrast material used for each patient. Imaging protocol Diagnostic efficacy To allow direct measurement of abdominal arterial en- Diagnostic efficacy (primary endpoint) of the CT exami- hancement, the study examination consisted
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