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CLINICAL RESEARCH: CARDIAC IMAGING

Initial Clinical Experience With Regadenoson, a Novel Selective A_2A Agonist for Pharmacologic Stress Single-Photon Emission Computed Tomography Myocardial Perfusion Imaging

Robert C. Hendel, MD^_*,1,2,_*, Timothy M. Bateman, MD^1,2,, Manuel D. Cerqueira, MD^1,2,, Ami E. Iskandrian, MD^1,, Jeffrey A. Leppo, MD^1,||, Brent Blackburn, PhD^¶ and John J. Mahmarian, MD^1,2,#

^_* Rush University Medical Center, Chicago, Illinois
Cardiovascular Consultants, Kansas City, Missouri
Cleveland Clinic, Cleveland, Ohio
University of Alabama at Birmingham, Birmingham, Alabama
^|| Berkshire Medical Center, Pittsfield, Massachusetts
^¶ CV Therapeutics, Palo Alto, California
^# Methodist DeBakey Heart Center, The Methodist Hospital/Baylor College of Medicine, Houston, Texas

Manuscript received January 24, 2005; revised manuscript received April 24, 2005, accepted May 18, 2005.

^_* Reprint requests and correspondence: Dr. Robert C. Hendel, 912 Northwest Highway, Suite 7, Fox River Grove, Illinois. (Email: rhendel{at}midwestheart.org).

OBJECTIVES: Regadenoson, a selective A_2A adenosine receptor agonist, was evaluated for tolerability and effectiveness as a pharmacological stress agent for detecting reversible myocardial hypoperfusion when combined with single-photon emission computed tomography (SPECT).

BACKGROUND: Adenosine and dipyridamole are nonselective adenosine agonists currently used as pharmacologic stressors. Despite proven safety, these agents often cause undesirable side effects and require a continuous infusion.

METHODS: This Phase II, multicenter, open-label trial was conducted in 36 patients who had demonstrated ischemia on a 6-min adenosine SPECT imaging study within the previous 2 to 46 days. Patients received regadenoson as a rapid intravenous bolus dose of 400 µg (n = 18) or 500 µg (n = 18). The radiopharmaceutical was then delivered within one minute. The SPECT images were acquired in a standard manner and uniformly processed at a central laboratory. Regadenoson and adenosine studies were presented in random order and interpreted blindly with a 17-segment model by three observers. Additionally, quantitative analysis was performed with 4D-MSPECT software (University of Michigan, Ann Arbor, Michigan).

RESULTS: Overall agreement for the presence of reversible hypoperfusion was 86%. The 400-µg dose was better tolerated. Overall, regadenoson was well-tolerated; side effects (e.g., chest discomfort, flushing, dyspnea) were generally mild in severity and self-limiting. High-grade atrioventricular block and bronchospasm were not observed.

CONCLUSIONS: Regadenoson is well-tolerated and seems as effective as adenosine for detecting and quantifying the extent of hypoperfusion observed with SPECT perfusion imaging. Phase III clinical trials are now underway, given the promise of regadenoson’s reduced side effects and simplicity of bolus administration.

Abbreviations and Acronyms   AV = atrioventricular   IV = intravenous   MPI = myocardial perfusion imaging   SBP = systolic blood pressure   SDS = summed difference score (SSS – SRS)   SPECT = single-photon emission computed tomography   SRS = summed rest score   SSS = summed stress score

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