Abstract 1384: Safety of Regadenoson in Patients With End-Stage Renal Disease
Background: Regadenoson is a selective A2A receptor agonist that was recently approved by the Food and Drug Administration for vasodilator stress myocardial perfusion imaging (MPI). Since the drug is cleared by renal excretion, its safety in patients with end-stage renal disease (ESRD) on hemodialysis needs to determined as such patients often undergo stress MPI before kidney transplantation or for other clinical indications.
Methods: There were 277 consecutive patients with ESRD who had regadenoson stress gated SPECT MPI and the results were compared to 134 patients with normal kidney function who were studied during the same time period for clinical indications.
Results: There were 164 men (59%) in ESRD vs. 73 men (54%) in the control group (p=NS). The patients with ESRD were younger than the control group (52±11 vs. 61±12 years (p <0.001). The MPI images were normal in 224 patients (81%) and showed fixed or reversible perfusion defects in 53 patients (19 %) with ESRD. In the control group, the images were normal in 110 patients (82%) and abnormal in 24 patients (18 %) (p=NS). The left ventricular ejection fraction was 57±12% in ESRD and 64±12 % in control patients (p <0.001). The changes in heart rate and systolic blood pressure from baseline to peak stress were 20±12 vs. 22±13 bpm and −11±24 vs. −12±23 mmHg in ESRD and control patients respectively (p=NS for both). The changes in diastlolic blood pressure were also not significantly different. The side effects profile was similar in the 2 groups and very few reported symptoms during the stress test in either group. There were no medication related hospitalizations, serious events or death in either group within 30 days of the study.
Conclusion: This is the first study to document the safety of regadenoson in a large number of patients with ESRD; the drug was well tolerated and it’s hemodynamic and side effects profiles were similar to patients with normal kidney function.