A randomized, multicenter, multivendor study of myocardial perfusion imaging with regadenoson CT perfusion vs single photon emission CT.
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 ≥ 45 years; women ≥ 50 years) 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.
Department of Radiology, Baptist Hospital of Miami, 8900 North Kendall Drive, Miami, FL 33176, USA; Miami Cardiac and Vascular Institute, Miami, FL, USA. Electronic address: rcury@baptisthealth.net.
Ricardo C
RC
Cury
Astellas Scientific and Medical Affairs, Inc., Northbrook, IL, USA.
Therese M
TM
Kitt
Astellas Pharma Global Development, Inc., Northbrook, IL, USA.
Kathleen
K
Feaheny
Cardiovascular Division, Department of Radiology, Brigham and Women's Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.
Ron
R
Blankstein
Harvard Medical School, Boston, MA, USA; Department of Radiology, Massachusetts General Hospital, Boston, MA, USA.
Brian B
BB
Ghoshhajra
Department of Medicine, Harbor UCLA Medical Center, Los Angeles, CA, USA.
Matthew J
MJ
Budoff
Division of Cardiology, Department of Medical Imaging, St Paul's Hospital, Vancouver, British Columbia, Canada.
Jonathon
J
Leipsic
Department of Radiology, Weill Cornell Medical College and The New York-Presbyterian Hospital, New York, NY, USA; Department of Medicine, Weill Cornell Medical College and The New York-Presbyterian Hospital, New York, NY, USA.
James K
JK
Min
Astellas Pharma Global Development, Inc., Northbrook, IL, USA.
Jamie
J
Akin
Division of Cardiology, Department of Medicine, Johns Hopkins University, Baltimore, MD, USA.
Richard T
RT
George
D000368:Aged; D016001:Confidence Intervals; D017023:Coronary Angiography / Q000379:methods; D023921:Coronary Stenosis / Q000000981:diagnostic imaging; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000000981:diagnostic imaging; D017202:Myocardial Ischemia / Q000000981:diagnostic imaging*; D055414:Myocardial Perfusion Imaging / Q000379:methods*; D015588:Observer Variation; D011687:Purines; D011720:Pyrazoles; D012680:Sensitivity and Specificity; D015899:Tomography, Emission-Computed, Single-Photon / Q000379:methods*; D014057:Tomography, X-Ray Computed / Q000379:methods*
D011687:Purines; D011720:Pyrazoles; C430916:regadenoson
CT perfusion; Myocardial ischemia; Regadenoson; Single photon emission CT