title: The EXERRT trial: "EXErcise to Regadenoson in Recovery Trial": A phase 3b, open-label, parallel group, randomized, multicenter study to assess regadenoson administration following an inadequate exercise stress test as compared to regadenoson without exercise for myocardial perfusion imaging using a SPECT protocol.
abstract: This study assessed the non-inferiority and safety of regadenoson administration during recovery from inadequate exercise compared with administration without exercise.
  
  
  
  Patients unable to achieve adequate exercise stress were randomized to regadenoson 0.4 mg either during recovery (Ex-Reg) or 1 hour after inadequate exercise (Regadenoson) (MPI1). All patients also underwent non-exercise regadenoson MPI 1-14 days later (MPI2). The number of segments with reversible perfusion defects (RPDs) detected using single photon emission computerized tomography imaging was categorized. The primary analysis evaluated the majority agreement rate between Ex-Reg and Regadenoson groups.
  
  
  
  1,147 patients were randomized. The lower bound of the 95% confidence interval of the difference in agreement rates (-6%) was above the -7.5% non-inferiority margin, demonstrating non-inferiority of Ex-Reg to Regadenoson. Adverse events were numerically less with Ex-Reg (MPI1). In the Ex-Reg group, one patient developed an acute coronary syndrome and another had a myocardial infarction following regadenoson after exercise. Upon review, both had electrocardiographic changes consistent with ischemia prior to regadenoson.
  
  
  
  Administering regadenoson during recovery from inadequate exercise results in comparable categorization of segments with RPDs and with careful monitoring appears to be well tolerated in patients without signs/symptoms of ischemia during exercise and recovery.
authors.affiliation: MemorialCare Heart & Vascular Institute, Long Beach Memorial, 2801 Atlantic Ave, Long Beach, CA, 90806, USA. gthomas1@memorialcare.org.|University of California, Irvine, CA, USA. gthomas1@memorialcare.org.
authors.forename: Gregory S
authors.initials: GS
authors.lastname: Thomas
authors.affiliation: AdaptivePharma, Leawood, KS, USA.|University of Missouri, Columbia, MO, USA.
authors.forename: S James
authors.initials: SJ
authors.lastname: Cullom
authors.affiliation: Astellas Pharma Global Development, Inc., Northbrook, IL, USA.
authors.forename: Therese M
authors.initials: TM
authors.lastname: Kitt
authors.affiliation: Astellas Pharma Global Development, Inc., Northbrook, IL, USA.
authors.forename: Kathleen M
authors.initials: KM
authors.lastname: Feaheny
authors.affiliation: Department of Internal Medicine, Heart and Vascular Institute, Henry Ford Hospital, Detroit, MI, USA.
authors.forename: Karthikeyan
authors.initials: K
authors.lastname: Ananthasubramaniam
authors.affiliation: Division of Radiological Sciences, Mallinckrodt Institute of Radiology, Washington University School of Medicine, St Louis, MO, USA.
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Gropler
authors.affiliation: Cardiovascular Nuclear Imaging Laboratory, New York Medical College, Westchester Medical Center, Valhalla, NY, USA.
authors.forename: Diwakar
authors.initials: D
authors.lastname: Jain
authors.affiliation: Saint Luke's Mid America Heart Institute, Kansas City, MO, USA.|University of Missouri-Kansas City, Kansas City, MO, USA.
authors.forename: Randall C
authors.initials: RC
authors.lastname: Thompson
mesh_terms: D003324:Coronary Artery Disease / Q000000981:diagnostic imaging*; D005080:Exercise Test / Q000187:drug effects* / Q000706:statistics & numerical data*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D055414:Myocardial Perfusion Imaging / Q000379:methods / Q000706:statistics & numerical data*; D011687:Purines / Q000008:administration & dosage*; D011720:Pyrazoles / Q000008:administration & dosage*; D020127:Recovery of Function / Q000187:drug effects; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D015899:Tomography, Emission-Computed, Single-Photon / Q000706:statistics & numerical data*; D014481:United States; D014665:Vasodilator Agents / Q000008:administration & dosage
chemical_list: D011687:Purines; D011720:Pyrazoles; D014665:Vasodilator Agents; C430916:regadenoson
keywords: Exercise; myocardial perfusion imaging; pharmacologic stress; regadenoson; vasodilator stress