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

Gregory S. Thomas, S. James Cullom, Therese M. Kitt, Kathleen M. Feaheny, Karthikeyan Ananthasubramaniam, Robert J. Gropler, Diwakar Jain, Randall C. Thompson

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13 Scopus citations

Abstract

Background: This study assessed the non-inferiority and safety of regadenoson administration during recovery from inadequate exercise compared with administration without exercise. Methods: 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. Results: 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. Conclusions: 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.

Original languageEnglish
Pages (from-to)788-802
Number of pages15
JournalJournal of Nuclear Cardiology
Volume24
Issue number3
DOIs
StatePublished - Jun 1 2017

Keywords

  • Exercise
  • myocardial perfusion imaging
  • pharmacologic stress
  • regadenoson
  • vasodilator stress

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