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Effects of Age, Gender, Obesity, and Diabetes on the Efficacy and Safety of the Selective A_2A Agonist Regadenoson Versus Adenosine in Myocardial Perfusion Imaging

Integrated ADVANCE-MPI Trial Results

Manuel D. Cerqueira, MD, FACC^_*,_*, Patricia Nguyen, MD, Peter Staehr, MD, S. Richard Underwood, MD, FACC, Ami E. Iskandrian, MD, MACC on behalf of the ADVANCE-MPI Trial Investigators

^_* Departments of Nuclear Medicine and Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio
Cardiovascular Therapeutics, Inc., Palo Alto, California
Imperial College London, Royal Brompton Hospital, London, England
University of Alabama, Birmingham, Alabama.

^_* Reprint requests and correspondence: Dr. Manuel D. Cerqueira, Departments of Nuclear Medicine and Cardiovascular Medicine, Cleveland Clinic (Gb3), 9500 Euclid Avenue, Cleveland, Ohio 44195. (Email: cerquem{at}ccf.org).

Objectives: To compare the effects of age, gender, body mass index, and diabetes on the safety and efficacy of regadenoson stress myocardial perfusion imaging, and to assess the noninferiority of regadenoson to adenosine for the detection of reversible myocardial perfusion defects.

Background: Previous reports have shown that a fixed unit bolus of regadenoson is safe and noninferior to adenosine for the detection of reversible perfusion defects by radionuclide imaging.

Methods: Using a database of 2,015 patients, we evaluated the effects of age, gender, body mass index, and diabetes on the safety and efficacy of regadenoson compared to adenosine.

Results: For detection of ischemia relative to adenosine, noninferiority was demonstrated for all patients (agreement rate difference 0%, 95% CI –6.2% to +6.8%). The average agreement rate between adenosine-adenosine and adenosine-regadenoson were 0.62 ± 0.03 and 0.63 ± 0.02. Detection of ischemia was also comparable in specific subgroups. Agreement was less for both agents in women versus men with moderate and large areas of ischemia. Compared to adenosine, regadenoson had a lower combined symptom score and less chest pain, flushing, and throat, neck, or jaw pain, but more headache and gastrointestinal discomfort. This was true in nearly all subgroups. Regadenoson patients reported feeling more comfortable (1.7 ± .02 vs. 1.9 ± 0.03, p < 0.001). Based on the overall tolerability score, women felt less comfortable than men with both stress agents. Image quality was rated good or excellent in 92% for both agents.

Conclusions: Regadenoson can be safely administered as a fixed unit bolus and is as efficacious as adenosine in detecting ischemia regardless of age, gender, body mass index, and diabetes. Regadenoson is better tolerated overall and across various subgroups.

Abbreviations and Acronyms   AV = atrioventricular   BMI = body mass index   DM = diabetes mellitus   MPI = myocardial perfusion imaging   SDS = summed difference score   SPECT = Single photon emission computed tomography   SSS = summed stress score

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