TY - JOUR
T1 - Adenosine versus regadenoson comparative evaluation in myocardial perfusion imaging
T2 - Results of the ADVANCE phase 3 multicenter international trial
AU - Iskandrian, Ami E.
AU - Bateman, Timothy M.
AU - Belardinelli, Luiz
AU - Blackburn, Brent
AU - Cerqueira, Manuel D.
AU - Hendel, Robert C.
AU - Lieu, Hsiao
AU - Mahmarian, John J.
AU - Olmsted, Ann
AU - Underwood, S. Richard
AU - Vitola, João
AU - Wang, Whedy
PY - 2007/9
Y1 - 2007/9
N2 - Background: Earlier phase 1 and 2 studies have shown that regadenoson has desirable features as a stress agent for myocardial perfusion imaging. Methods and Results: This multicenter, double-blinded phase 3 trial involved 784 patients at 54 sites. Each patient underwent 2 sets of gated single photon emission computed tomography myocardial perfusion imaging studies: an initial qualifying study with adenosine and a subsequent randomized study with either regadenoson (2/3 of patients) or adenosine. Regadenoson was administered as a rapid bolus (<10 seconds) of 400 μg. The primary endpoint was to demonstrate noninferiority by showing that the difference in the strength of agreement in detecting reversible defects, based on blinded reading, between sequential adenosine-regadenoson images and adenosine-adenosine images, lay above a prespecified noninferiority margin. Other prospectively defined safety and tolerability comparisons and supporting analyses were also performed. The average agreement rate based on the median of 3 independent blinded readers was 0.63 ± 0.03 for regadenoson-adenosine and 0.64 ± 0.04 for adenosine-adenosine-a 1% absolute difference with the lower limit of the 95% confidence interval lying above the prespecified noninferiority margin. Side-by-side interpretation of regadenoson and adenosine images provided comparable results for detecting reversible defects. The peak increase in heart rate was greater with regadenoson than adenosine, but the blood pressure nadir was similar. A summed symptom score of flushing, chest pain, and dyspnea was less with regadenoson than adenosine (P = .013). Conclusions: This phase 3 trial shows that regadenoson provides diagnostic information comparable to a standard adenosine infusion. There were no serious drug-related side effects, and regadenoson was better tolerated than adenosine.
AB - Background: Earlier phase 1 and 2 studies have shown that regadenoson has desirable features as a stress agent for myocardial perfusion imaging. Methods and Results: This multicenter, double-blinded phase 3 trial involved 784 patients at 54 sites. Each patient underwent 2 sets of gated single photon emission computed tomography myocardial perfusion imaging studies: an initial qualifying study with adenosine and a subsequent randomized study with either regadenoson (2/3 of patients) or adenosine. Regadenoson was administered as a rapid bolus (<10 seconds) of 400 μg. The primary endpoint was to demonstrate noninferiority by showing that the difference in the strength of agreement in detecting reversible defects, based on blinded reading, between sequential adenosine-regadenoson images and adenosine-adenosine images, lay above a prespecified noninferiority margin. Other prospectively defined safety and tolerability comparisons and supporting analyses were also performed. The average agreement rate based on the median of 3 independent blinded readers was 0.63 ± 0.03 for regadenoson-adenosine and 0.64 ± 0.04 for adenosine-adenosine-a 1% absolute difference with the lower limit of the 95% confidence interval lying above the prespecified noninferiority margin. Side-by-side interpretation of regadenoson and adenosine images provided comparable results for detecting reversible defects. The peak increase in heart rate was greater with regadenoson than adenosine, but the blood pressure nadir was similar. A summed symptom score of flushing, chest pain, and dyspnea was less with regadenoson than adenosine (P = .013). Conclusions: This phase 3 trial shows that regadenoson provides diagnostic information comparable to a standard adenosine infusion. There were no serious drug-related side effects, and regadenoson was better tolerated than adenosine.
KW - Adenosine
KW - coronary artery disease
KW - ischemia
KW - perfusion imaging
KW - regadenoson
KW - single photon emission computed tomography
KW - stress imaging
UR - http://www.scopus.com/inward/record.url?scp=34548394451&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=34548394451&partnerID=8YFLogxK
U2 - 10.1016/j.nuclcard.2007.06.114
DO - 10.1016/j.nuclcard.2007.06.114
M3 - Article
C2 - 17826318
AN - SCOPUS:34548394451
VL - 14
SP - 645
EP - 658
JO - Journal of Nuclear Cardiology
JF - Journal of Nuclear Cardiology
SN - 1071-3581
IS - 5
ER -