title: Diagnostic Accuracy, Image Quality, and Patient Comfort for Coronary CT Angiography Performed Using Iso-Osmolar versus Low-Osmolar Iodinated Contrast: A Prospective International Multicenter Randomized Controlled Trial.
abstract: The impact of iso-osmolar versus low-osmolar iodinated contrast on diagnostic accuracy for coronary computed tomography angiography (CCTA), against the reference standard of invasive coronary angiography (ICA), has not been determined. We sought to compare in an international multicenter randomized controlled trial the impact of iso-osmolar iodixanol versus low-osmolar iopamidol on diagnostic accuracy, image quality, patient symptoms, and heart rate variability.
  
  
  
  Adult patients who were clinically referred for ICA were randomly assigned to receive either iodixanol (n = 133) or iopamidol (n = 133) with an investigational CCTA. CCTA stenosis and image quality were scored by consensus of independent blinded core laboratory readers. Degree of stenosis by ICA was evaluated using quantitative coronary angiography and used to calculate diagnostic accuracy. Heart rate variability and patient-reported symptom questionnaires were compared between the two groups.
  
  
  
  A total of 266 subjects underwent both CCTA and ICA (57 ± 11 years, 58% male). The sensitivity, specificity, positive predictive value, negative predictive value, and accuracy for detecting coronary artery disease were 86.8%, 93.7%, 84.6%, 94.7%, and 91.7% for iodixanol and 94.7%, 88.4%, 76.6%, 97.7%, and 90.2% for iopamidol, respectively, on a per-patient level. These values were not significantly different between the two groups. There was no significant difference in image quality and heart rate increase or variability. The majority of patients reported symptoms (59.4%), with no differences in the overall or individual rate of any or moderate to severe symptoms between the two groups. Patients receiving iodixanol reported lower incidence of moderate to severe flushing (3.0% vs. 12.8%, P = .005). Lower rates of moderate to severe symptoms were particularly evident for patients with ≥55 years receiving iodixanol versus iopamidol (8.5% vs. 24.6%, P = .01).
  
  
  
  Diagnostic performance and image quality were similar for CCTA performed with iso-osmolar versus low-osmolar iodinated contrast. Indices of patient comfort were improved with iso-osmolar iodinated contrast.
authors.affiliation: Department of Radiology, Weill Cornell Medical College, New York, New York; St. Luke's International Hospital, Tokyo, Japan.
authors.forename: Ryo
authors.initials: R
authors.lastname: Nakazato
authors.affiliation: Department of Imaging, Cedars-Sinai Medical Center, Los Angeles, California.
authors.forename: Reza
authors.initials: R
authors.lastname: Arsanjani
authors.affiliation: Department of Radiology, Weill Cornell Medical College, New York, New York; Soroka University Medical Center, Be'er Sheva, Israel.
authors.forename: Aryeh
authors.initials: A
authors.lastname: Shalev
authors.affiliation: St. Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada.
authors.forename: Jonathon A
authors.initials: JA
authors.lastname: Leipsic
authors.affiliation: Department of Imaging, Cedars-Sinai Medical Center, Los Angeles, California.
authors.forename: Heidi
authors.initials: H
authors.lastname: Gransar
authors.affiliation: Department of Radiology, Weill Cornell Medical College, New York, New York.
authors.forename: Fay Y
authors.initials: FY
authors.lastname: Lin
authors.affiliation: Department of Radiology, Weill Cornell Medical College, New York, New York.
authors.forename: Millie
authors.initials: M
authors.lastname: Gomez
authors.affiliation: Department of Imaging, Cedars-Sinai Medical Center, Los Angeles, California.
authors.forename: Daniel S
authors.initials: DS
authors.lastname: Berman
authors.affiliation: Department of Radiology, Weill Cornell Medical College, New York, New York; Department of Medicine, Weill Cornell Medical College, New York, New York; Dalio Institute of Cardiovascular Imaging, New York-Presbyterian Hospital, New York, New York. Electronic address: jkm2001@med.cornell.edu.
authors.forename: James K
authors.initials: JK
authors.lastname: Min
mesh_terms: D000072226:Computed Tomography Angiography / Q000379:methods*; D003287:Contrast Media; D017023:Coronary Angiography / Q000379:methods*; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging; D005260:Female; D006801:Humans; D007089:Image Enhancement; D007479:Iopamidol; D008297:Male; D008875:Middle Aged; D009994:Osmolar Concentration; D000070659:Patient Comfort; D011446:Prospective Studies; D012680:Sensitivity and Specificity; D014283:Triiodobenzoic Acids
chemical_list: D003287:Contrast Media; D014283:Triiodobenzoic Acids; C044834:iodixanol; D007479:Iopamidol
keywords: Iso-osmolar contrast agent; coronary CT; diagnostic accuracy; image quality