Safety and tolerability of regadenoson CMR.
OBJECTIVE
Knowledge of adverse events associated with regadenoson perfusion cardiac magnetic resonance (CMR) and patient tolerability has implications for patient safety and staff training. We sought to assess the safety and tolerability of regadenoson stress CMR.


METHODS
A group of 728 consecutive patients (median age 58, 44% female) and 25 normal volunteers (median age 21, 24% female) were recruited from August 2009 to March 2012 using a prospective, cross-sectional study design. Subjects were stressed using fixed-dose regadenoson and imaged using a 1.5T MRI scanner. Symptoms and adverse events including death, myocardial infarction (MI), ventricular tachycardia (VT)/ventricular fibrillation (VF), hospitalization, arrhythmias, and haemodynamic stability were assessed.


RESULTS
There were no occurrences of death, MI, VT/VF, high-grade atrioventricular block, or stress-induced atrial fibrillation. Notable adverse events included one case of bronchospasm and one case of heart failure exacerbation resulting in hospitalization. The most common symptoms in patients were dyspnoea (30%, n = 217), chest discomfort (27%, n = 200), and headache (15%, n = 111). There was minimal change between baseline and peak systolic and diastolic blood pressure in both patients and volunteers (P > 0.05). A blunted heart rate response to regadenoson was noted in patients with body mass index (BMI) ≥ 30 kg/m(2) (P < 0.001), and diabetes (P = 0.001).


CONCLUSIONS
Regadenoson CMR is well tolerated and can be performed safely with few adverse events.
Cardiovascular and Pulmonary Branch, National Heart, Lung and Blood Institute, National Institutes of Health, 10 Center Drive Bldg 10, Rm B1D416, MSC 1061, Bethesda, MD 20892-1061, USA Division of Cardiology, David Geffen School of Medicine at UCLA, Los Angeles, CA 90073, USA.
Kim-Lien
KL
Nguyen
Cardiovascular and Pulmonary Branch, National Heart, Lung and Blood Institute, National Institutes of Health, 10 Center Drive Bldg 10, Rm B1D416, MSC 1061, Bethesda, MD 20892-1061, USA.
W Patricia
WP
Bandettini
Cardiovascular and Pulmonary Branch, National Heart, Lung and Blood Institute, National Institutes of Health, 10 Center Drive Bldg 10, Rm B1D416, MSC 1061, Bethesda, MD 20892-1061, USA.
Sujata
S
Shanbhag
Cardiovascular and Pulmonary Branch, National Heart, Lung and Blood Institute, National Institutes of Health, 10 Center Drive Bldg 10, Rm B1D416, MSC 1061, Bethesda, MD 20892-1061, USA Division of Cardiovascular Medicine, University of Kentucky, Lexington, KY 40536, USA.
Steve W
SW
Leung
Cardiovascular and Pulmonary Branch, National Heart, Lung and Blood Institute, National Institutes of Health, 10 Center Drive Bldg 10, Rm B1D416, MSC 1061, Bethesda, MD 20892-1061, USA Division of Cardiovascular Medicine, University of California, San Diego, San Diego, CA 92103, USA.
Joel R
JR
Wilson
Cardiovascular and Pulmonary Branch, National Heart, Lung and Blood Institute, National Institutes of Health, 10 Center Drive Bldg 10, Rm B1D416, MSC 1061, Bethesda, MD 20892-1061, USA araia@nih.gov.
Andrew E
AE
Arai
D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D016022:Case-Control Studies; D016009:Chi-Square Distribution; D003287:Contrast Media / Q000009:adverse effects; D004361:Drug Tolerance; D005260:Female; D006801:Humans; D016015:Logistic Models; D019028:Magnetic Resonance Imaging, Cine / Q000009:adverse effects / Q000379:methods*; D008297:Male; D008875:Middle Aged; D055414:Myocardial Perfusion Imaging / Q000009:adverse effects / Q000379:methods; D061214:Patient Safety; D011687:Purines / Q000009:adverse effects; D011720:Pyrazoles / Q000009:adverse effects; D012372:ROC Curve; D018570:Risk Assessment; D018709:Statistics, Nonparametric; D055815:Young Adult
D003287:Contrast Media; D011687:Purines; D011720:Pyrazoles; C430916:regadenoson
Cardiovascular MRI; Coronary artery disease; Myocardial perfusion; Perfusion imaging; Regadenoson; Vasodilator agents