TY - JOUR
T1 - A randomized, multicenter, multivendor study of myocardial perfusion imaging with regadenoson CT perfusion vs single photon emission CT
AU - Cury, Ricardo C.
AU - Kitt, Therese M.
AU - Feaheny, Kathleen
AU - Blankstein, Ron
AU - Ghoshhajra, Brian B.
AU - Budoff, Matthew J.
AU - Leipsic, Jonathon
AU - Min, James K.
AU - Akin, Jamie
AU - George, Richard T.
N1 - Funding Information:
Conflict of interest: Ricardo C. Cury has received grants and research support from Astellas . Therese M. Kitt, Kathleen Feaheny, and Jamie Akin are employees of Astellas. Ron Blankstein has received grants and research support from Astellas . Matthew J. Budoff has received grants and research support from Astellas and GE Healthcare . Jonathon Leipsic has received consulting fees and honoraria from GE Healthcare and Heartflow and fees for image reading from ICON and Astellas for this study. James K. Min has research agreements with Philips Healthcare and Vital Images, has received consulting fees and honoraria from Abbott Vascular, GE Healthcare, and Heartflow, has served on medical advisory boards for Arineta, and holds equity interest in Autoplaq, MDDX, and TC3. Richard T. George has received consulting fees and honoraria from ICON Medical Imaging, has served on advisory boards for Astellas, has received grants and research support from Toshiba and GE Healthcare , educational grants from Toshiba, holds a patent for an x-ray CT apparatus and myocardial perfusion image generating system (US 7,853,309, issued December 2010), and has a pending patent for “combined multi-detector CT angiography and CT myocardial perfusion imaging for the diagnosis of coronary artery disease” (US 2011/0110,488, filed September 2008). Brian B. Ghoshhajra has no potential conflicts of interest to declare.
Funding Information:
The study was supported by Astellas Pharma Global Development . Medical writing support was provided by Emily Howard and Tara N Miller, PhD, and by medical writers at Envision Scientific Solutions, and was funded by Astellas Scientific and Medical Affairs, Inc.
Publisher Copyright:
© 2015 The Authors.
PY - 2015
Y1 - 2015
N2 - Background: Myocardial CT perfusion (CTP) is a promising tool for the detection of myocardial ischemia. We hypothesize that regadenoson CTP is noninferior to regadenoson single photon emission CT (SPECT) for detecting or excluding myocardial ischemia. Methods: Patients (men ≥45years; women ≥50years) with known or suspected coronary artery disease (n= 124) were randomized to 1 of 2 diagnostic sequences: rest and regadenoson SPECT on day 1, then regadenoson CTP and rest CTP (and coronary CT angiography [CTA]) (CTA; same acquisition) on day 2 or regadenoson CTP and rest CTP (and CTA) on Day 1, then rest and regadenoson SPECT on day 2. Scanning platforms included 64-, 128-, 256-, and 320-slice systems. The primary analysis examined the agreement rate between CTP and SPECT for detecting or excluding reversible ischemia in ≥2 myocardial segments as assessed by independent, blinded readers. Results: Complete and interpretable CTP and SPECT scans were obtained for 110 patients. Regadenoson CTP was noninferior to SPECT for detecting or excluding reversible ischemia with an agreement rate of 0.87 (95% confidence interval [CI], 0.77-0.97) and sensitivity and specificity of 0.90 (95% CI, 0.71-1.00) and 0.84 (95% CI, 0.77-0.91), respectively. The agreement rate for detecting or excluding ≥1 fixed defects by regadenoson CTP and SPECT was 0.86 (95% CI, 0.74-0.98). With SPECT as the reference standard, the diagnostic accuracies for detecting or excluding ischemia by regadenoson CTP and CTA alone were 0.85 (95% CI, 0.78-0.91) and 0.69 (95% CI, 0.60-0.77), respectively. Conclusions: This study establishes the noninferiority of regadenoson CTP to SPECT for detecting or excluding myocardial ischemia.
AB - Background: Myocardial CT perfusion (CTP) is a promising tool for the detection of myocardial ischemia. We hypothesize that regadenoson CTP is noninferior to regadenoson single photon emission CT (SPECT) for detecting or excluding myocardial ischemia. Methods: Patients (men ≥45years; women ≥50years) with known or suspected coronary artery disease (n= 124) were randomized to 1 of 2 diagnostic sequences: rest and regadenoson SPECT on day 1, then regadenoson CTP and rest CTP (and coronary CT angiography [CTA]) (CTA; same acquisition) on day 2 or regadenoson CTP and rest CTP (and CTA) on Day 1, then rest and regadenoson SPECT on day 2. Scanning platforms included 64-, 128-, 256-, and 320-slice systems. The primary analysis examined the agreement rate between CTP and SPECT for detecting or excluding reversible ischemia in ≥2 myocardial segments as assessed by independent, blinded readers. Results: Complete and interpretable CTP and SPECT scans were obtained for 110 patients. Regadenoson CTP was noninferior to SPECT for detecting or excluding reversible ischemia with an agreement rate of 0.87 (95% confidence interval [CI], 0.77-0.97) and sensitivity and specificity of 0.90 (95% CI, 0.71-1.00) and 0.84 (95% CI, 0.77-0.91), respectively. The agreement rate for detecting or excluding ≥1 fixed defects by regadenoson CTP and SPECT was 0.86 (95% CI, 0.74-0.98). With SPECT as the reference standard, the diagnostic accuracies for detecting or excluding ischemia by regadenoson CTP and CTA alone were 0.85 (95% CI, 0.78-0.91) and 0.69 (95% CI, 0.60-0.77), respectively. Conclusions: This study establishes the noninferiority of regadenoson CTP to SPECT for detecting or excluding myocardial ischemia.
KW - CT perfusion
KW - Myocardial ischemia
KW - Regadenoson
KW - Single photon emission CT
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U2 - 10.1016/j.jcct.2015.01.002
DO - 10.1016/j.jcct.2015.01.002
M3 - Article
C2 - 25726411
AN - SCOPUS:84930927308
SN - 1934-5925
VL - 9
SP - 103-112.e2
JO - Journal of cardiovascular computed tomography
JF - Journal of cardiovascular computed tomography
IS - 2
ER -