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Open Access 01-02-2017 | Contrast Media

Comparative assessment of image quality for coronary CT angiography with iobitridol and two contrast agents with higher iodine concentrations: iopromide and iomeprol. A multicentre randomized double-blind trial

Authors: Stephan Achenbach, Jean-François Paul, François Laurent, Hans-Christoph Becker, Marco Rengo, Jerome Caudron, Sebastian Leschka, Olivier Vignaux, Gesine Knobloch, Giorgio Benea, Thomas Schlosser, Jordi Andreu, Beatriz Cabeza, Alexis Jacquier, Miguel Souto, Didier Revel, Salah Dine Qanadli, Filippo Cademartiri, on behalf of the X-ACT Study Group

Published in: European Radiology | Issue 2/2017

Abstract

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.

Rahsepar AA, Arbab-Zadeh A (2015) Cardiac CT vs. stress testing in patients with suspected coronary artery disease: review and expert recommendations. Curr Cardiovasc Imaging Rep 8

Roifman I, Rezai MR, Wijeysundera HC et al (2015) Utilization of cardiac computed tomography angiography and outpatient invasive coronary angiography in Ontario, Canada. J Cardiovasc Comput Tomogr 9:567–571CrossRefPubMed

Al-Mallah MH, Aljizeeri A, Villines TC et al (2015) Cardiac computed tomography in current cardiology guidelines. J Cardiovasc Comput Tomogr 9:514–523CrossRefPubMed

Lell M, Marwan M, Schepis T et al (2009) Prospectively ECG-triggered high-pitch spiral acquisition for coronary CT angiography using dual source CT: technique and initial experience. Eur Radiol 19:2576–2583CrossRefPubMed

Schuhbaeck A, Achenbach S, Layritz C et al (2013) Image quality of ultra-low radiation exposure coronary CT angiography with an effective dose <0.1 mSv using high-pitch spiral acquisition and raw data-based iterative reconstruction. Eur Radiol 23:597–606CrossRefPubMed

Maffei E, Martini C, De Crescenzo S et al (2010) Low dose CT of the heart: a quantum leap into a new era of cardiovascular imaging. Radiol Med 115:1179–1207CrossRefPubMed

Weustink AC, Neefjes LA, Kyrzopoulos S et al (2009) Impact of heart rate frequency and variability on radiation exposure, image quality, and diagnostic performance in dual-source spiral CT coronary angiography. Radiology 253:672–680CrossRefPubMed

Weustink AC, Mollet NR, Neefjes LA et al (2009) Preserved diagnostic performance of dual-source CT coronary angiography with reduced radiation exposure and cancer risk. Radiology 252:53–60CrossRefPubMed

Gordic S, Desbiolles L, Sedlmair M et al (2016) Optimizing radiation dose by using advanced modelled iterative reconstruction in high-pitch coronary CT angiography. Eur Radiol 26:459–468CrossRefPubMed

10.

Dey D, Schuhbaeck A, Min JK, Berman DS, Achenbach S (2013) Non-invasive measurement of coronary plaque from coronary CT angiography and its clinical implications. Expert Rev Cardiovasc Ther 11:1067–1077CrossRefPubMed

11.

Fischer C, Hulten E, Belur P, Smith R, Voros S, Villines TC (2013) Coronary CT angiography versus intravascular ultrasound for estimation of coronary stenosis and atherosclerotic plaque burden: a meta-analysis. J Cardiovasc Comput Tomogr 7:256–266CrossRefPubMed

12.

Cademartiri F, La Grutta L, Palumbo AA et al (2006) Coronary plaque imaging with multislice computed tomography: technique and clinical applications. Eur Radiol 16:M44–M53CrossRefPubMed

13.

Agatston AS, Janowitz WR, Hildner FJ, Zusmer NR, Viamonte M Jr, Detrano R (1990) Quantification of coronary artery calcium using ultrafast computed tomography. J Am Coll Cardiol 15:827–832CrossRefPubMed

14.

Becker CR, Vanzulli A, Fink C et al (2011) Multicenter comparison of high concentration contrast agent iomeprol-400 with iso-osmolar iodixanol-320: contrast enhancement and heart rate variation in coronary dual-source computed tomographic angiography. Investig Radiol 46:457–464CrossRef

15.

Cademartiri F, Mollet NR, Lemos PA et al (2006) Higher intracoronary attenuation improves diagnostic accuracy in MDCT coronary angiography. AJR Am J Roentgenol 187:W430–W433CrossRefPubMed

16.

Cademartiri F, Maffei E, Palumbo AA et al (2008) Influence of intra-coronary enhancement on diagnostic accuracy with 64-slice CT coronary angiography. Eur Radiol 18:576–583CrossRefPubMed

17.

Cademartiri F, Runza G, Mollet NR et al (2005) Impact of intravascular enhancement, heart rate, and calcium score on diagnostic accuracy in multislice computed tomography coronary angiography. Radiol Med 110:42–51PubMed

18.

Fleischmann D (2005) How to design contrast injection protocols for multiple detector-row CT angiography (MDCTA). Eur Radiol 15:E60–E65CrossRefPubMed

19.

Cademartiri F, Mollet NR, van der Lugt A et al (2005) Intravenous contrast material administration at helical 16-detector row CT coronary angiography: effect of iodine concentration on vascular attenuation. Radiology 236:661–665CrossRefPubMed

20.

Katzberg RW, Barrett BJ (2007) Risk of iodinated contrast material--induced nephropathy with intravenous administration. Radiology 243:622–628CrossRefPubMed

21.

Thomsen HS, Morcos SK, Barrett BJ (2008) Contrast-induced nephropathy: the wheel has turned 360 degrees. Acta Radiol 49:646–657CrossRefPubMed

22.

Nyman U, Almen T, Aspelin P, Hellstrom M, Kristiansson M, Sterner G (2005) Contrast-medium-Induced nephropathy correlated to the ratio between dose in gram iodine and estimated GFR in ml/min. Acta Radiol 46:830–842CrossRefPubMed

23.

Cademartiri F, de Monye C, Pugliese F et al (2006) High iodine concentration contrast material for noninvasive multislice computed tomography coronary angiography: iopromide 370 versus iomeprol 400. Investig Radiol 41:349–353CrossRef

24.

Rist C, Nikolaou K, Kirchin MA et al (2006) Contrast bolus optimization for cardiac 16-slice computed tomography: comparison of contrast medium formulations containing 300 and 400 milligrams of iodine per milliliter. Investig Radiol 41:460–467CrossRef

25.

Kim EY, Yeh DW, Choe YH, Lee WJ, Lim HK (2010) Image quality and attenuation values of multidetector CT coronary angiography using high iodine-concentration contrast material: a comparison of the use of iopromide 370 and iomeprol 400. Acta Radiol 51:982–989CrossRefPubMedPubMedCentral

26.

Cademartiri F, Nieman K, van der Lugt A et al (2004) Intravenous contrast material administration at 16-detector row helical CT coronary angiography: test bolus versus bolus-tracking technique. Radiology 233:817–823CrossRefPubMed

27.

Cademartiri F, van der Lugt A, Luccichenti G, Pavone P, Krestin GP (2002) Parameters affecting bolus geometry in CTA: a review. J Comput Assist Tomogr 26:598–607CrossRefPubMed

28.

Rumberger JA, Sheedy PF 2nd, Breen JF, Fitzpatrick LA, Schwartz RS (1996) Electron beam computed tomography and coronary artery disease: scanning for coronary artery calcification. Mayo Clin Proc 71:369–377CrossRefPubMed

29.

Raff GL, Abidov A, Achenbach S et al (2009) SCCT guidelines for the interpretation and reporting of coronary computed tomographic angiography. J Cardiovasc Comput Tomogr 3:122–136CrossRefPubMed

30.

Begaud B, Evreux JC, Jouglard J, Lagier G (1985) Imputation of the unexpected or toxic effects of drugs. Actualization of the method used in France. Therapie 40:111–118PubMed

31.

Bae KT, Heiken JP, Brink JA (1998) Aortic and hepatic contrast medium enhancement at CT. Part II Effect of reduced cardiac output in a porcine model. Radiology 207:657–662CrossRefPubMed

32.

Bae KT, Heiken JP, Brink JA (1998) Aortic and hepatic contrast medium enhancement at CT. Part I. Prediction with a computer model. Radiology 207:647–655CrossRefPubMed

33.

Bae KT, Heiken JP, Brink JA (1998) Aortic and hepatic peak enhancement at CT: effect of contrast medium injection rate--pharmacokinetic analysis and experimental porcine model. Radiology 206:455–464CrossRefPubMed

34.

Bae KT, Tran HQ, Heiken JP (2000) Multiphasic injection method for uniform prolonged vascular enhancement at CT angiography: pharmacokinetic analysis and experimental porcine model. Radiology 216:872–880CrossRefPubMed

35.

Lembcke A, Schwenke C, Hein PA et al (2014) High-pitch dual-source CT coronary angiography with low volumes of contrast medium. Eur Radiol 24:120–127CrossRefPubMed

36.

Lell MM, Jost G, Korporaal JG et al (2015) Optimizing contrast media injection protocols in state-of-the art computed tomographic angiography. Investig Radiol 50:161–167CrossRef

37.

Oda S, Utsunomiya D, Yuki H et al (2015) Low contrast and radiation dose coronary CT angiography using a 320-row system and a refined contrast injection and timing method. J Cardiovasc Comput Tomogr 9:19–27CrossRefPubMed

38.

Yin WH, Lu B, Gao JB et al (2015) Effect of reduced x-ray tube voltage, low iodine concentration contrast medium, and sinogram-affirmed iterative reconstruction on image quality and radiation dose at coronary CT angiography: results of the prospective multicenter REALISE trial. J Cardiovasc Comput Tomogr 9:215–222CrossRefPubMed

39.

Mangold S, Wichmann JL, Schoepf UJ, et al (2016) Automated tube voltage selection for radiation dose and contrast medium reduction at coronary CT angiography using 3rd generation dual-source CT. Eur Radiol. Feb 4

40.

Kim R, Park EA, Lee W, Chung JW (2016) Feasibility of 320-row area detector CT coronary angiography using 40 mL of contrast material: assessment of image quality and diagnostic accuracy. Eur Radiol. Feb 23

41.

Petersein J, Peters CR, Wolf M, Hamm B (2003) Results of the safety and efficacy of iobitridol in more than 61,000 patients. Eur Radiol 13:2006–2011CrossRefPubMed

42.

Vogl TJ, Honold E, Wolf M, Mohajeri H, Hammerstingl R (2006) Safety of iobitridol in the general population and at-risk patients. Eur Radiol 16:1288–1297CrossRefPubMed

43.

Wendt-Nordahl G, Rotert H, Trojan L et al (2006) Intravenous contrast media in uroradiology: evaluation of safety and tolerability in almost 50,000 patients. Med Princ Pract 15:358–361CrossRefPubMed

Title: Comparative assessment of image quality for coronary CT angiography with iobitridol and two contrast agents with higher iodine concentrations: iopromide and iomeprol. A multicentre randomized double-blind trial
Authors: Stephan Achenbach
Jean-François Paul
François Laurent
Hans-Christoph Becker
Marco Rengo
Jerome Caudron
Sebastian Leschka
Olivier Vignaux
Gesine Knobloch
Giorgio Benea
Thomas Schlosser
Jordi Andreu
Beatriz Cabeza
Alexis Jacquier
Miguel Souto
Didier Revel
Salah Dine Qanadli
Filippo Cademartiri
on behalf of the X-ACT Study Group
Publication date: 01-02-2017
Publisher: Springer Berlin Heidelberg
Published in: European Radiology / Issue 2/2017
Print ISSN: 0938-7994
Electronic ISSN: 1432-1084
DOI: https://doi.org/10.1007/s00330-016-4437-9

At a glance: The STEP trials

Springer Medicine

Comparative assessment of image quality for coronary CT angiography with iobitridol and two contrast agents with higher iodine concentrations: iopromide and iomeprol. A multicentre randomized double-blind trial

Abstract

Objectives

Methods

Results

Conclusions

Key Points

At a glance: The STEP trials

Springer Medicine

Abstract

Objectives

Methods

Results

Conclusions

Key Points

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