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Clinical Trial
. 2017 Jun;24(3):788-802.
doi: 10.1007/s12350-017-0813-3. Epub 2017 Feb 21.

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  1   2 , S James Cullom  3   4 , Therese M Kitt  5 , Kathleen M Feaheny  5 , Karthikeyan Ananthasubramaniam  6 , Robert J Gropler  7 , Diwakar Jain  8 , Randall C Thompson  9   10
Affiliations
Clinical Trial

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 et al. J Nucl Cardiol. 2017 Jun.

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.

Trial registration: ClinicalTrials.gov NCT01618669.

Keywords: Exercise; myocardial perfusion imaging; pharmacologic stress; regadenoson; vasodilator stress.

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Figures

Figure 1
Figure 1
Illustration of the flow of patients through all stages of the study. *As described in the Methods section, patients experiencing signs or symptoms of ischemia prior to receiving regadenoson were not to be randomized. †Administered intravenously over 10 seconds. MPI, Myocardial perfusion imaging; SPECT, single photon emission computed tomography
Figure 2
Figure 2
Diagram outlining the flow of patients in the study, including events that precluded patients from analysis. Reasons for exclusion from efficacy analysis set were factors that prevented completion of all MPI assessments. MET, Metabolic equivalent; MPHR, maximum predicted heart rate
Figure 3
Figure 3
Primary endpoint: Majority agreement rate difference (results of the primary endpoint). MPI, Myocardial perfusion imaging; SE, standard error
Figure 4
Figure 4
Responses for heart rate (A) and systolic blood pressure (B). Illustration of the mean and SD changes in heart rates (A) and systolic blood pressure (B) over 60 minutes in Ex-Reg and Regadenoson during the first and second stress MPI procedures. MPI, Myocardial perfusion imaging; SD, standard deviation
See this image and copyright information in PMC

Comment in

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