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Detection of coronary artery disease with perfusion stress echocardiography using a novel ultrasound imaging agent: two Phase 3 international trials in comparison with radionuclide perfusion imaging
Citation
Senior, R and Monaghan, M and Main, ML and Zamorano, JL and Tiemann, K and Agati, L and Weissman, NJ and Klein, AL and Marwick, TH and Ahmad, M and DeMaria, AN and Zabalgoitia, M and Becher, H and Kaul, S and Udelson, JE and Wackers, FJ and Walovitch, RC and Picard, MH, Detection of coronary artery disease with perfusion stress echocardiography using a novel ultrasound imaging agent: two Phase 3 international trials in comparison with radionuclide perfusion imaging, European Journal of Echocardiography, 10, (1) pp. 26-35. ISSN 1525-2167 (2009) [Refereed Article]
Copyright Statement
Copyright 2009 Oxford University Press
DOI: doi:10.1093/ejechocard/jen321
Abstract
Aims To determine if perfusion stress echocardiography (PSE) with ImagifyTM (perflubutane polymer
microspheres) is comparable to stress perfusion imaging using 99mTc single photon emission computed
tomography (SPECT) for coronary artery disease (CAD) detection. PSE is a novel technique for evaluating
myocardial perfusion. RAMP (real-time assessment of myocardial perfusion)-1 and -2 were international,
Phase 3 trials that evaluated the ability of PSE with Imagify, to detect CAD.
Methods and results Chronic, stable, chest pain patients (n = 662) underwent Imagify PSE and gated SPECT imaging at rest and during dipyridamole stress. Independent blinded cardiologists [three PSE readers per trial, and four SPECT readers (one for RAMP-1, three for RAMP-2)] interpreted images. CAD was defined by quantitative coronary angiography or 90-day outcome with clinical review. Accuracy, sensitivity, and specificity were evaluated using non-inferiority analysis (one-sided alpha = 0.025) compared with SPECT. SPECT results for RAMP-1 and -2 were: accuracy (70%, 67%), sensitivity (78%, 61%), and specificity (64%, 76%). Accuracy of all six PSE readers was non-inferior to SPECT (66-71%, P <=0.004). Four demonstrated non-inferior sensitivity (68-77%, P<= 0.002), three demonstrated noninferior specificity (72-88%, P <= 0.013). Three PSE readers (RAMP-2) were superior for sensitivity. Two PSE readers (RAMP-1) were superior for specificity. Area under the multi-reader receiver operating characteristics curve (0.72) was equal for both modalities. Majority of adverse events followed dipyridamole dosing, and were mild, transient, and required no treatment.
Conclusions Imagify PSE was well-tolerated. Its diagnostic performance in chest pain patients is comparable with SPECT perfusion imaging.
Methods and results Chronic, stable, chest pain patients (n = 662) underwent Imagify PSE and gated SPECT imaging at rest and during dipyridamole stress. Independent blinded cardiologists [three PSE readers per trial, and four SPECT readers (one for RAMP-1, three for RAMP-2)] interpreted images. CAD was defined by quantitative coronary angiography or 90-day outcome with clinical review. Accuracy, sensitivity, and specificity were evaluated using non-inferiority analysis (one-sided alpha = 0.025) compared with SPECT. SPECT results for RAMP-1 and -2 were: accuracy (70%, 67%), sensitivity (78%, 61%), and specificity (64%, 76%). Accuracy of all six PSE readers was non-inferior to SPECT (66-71%, P <=0.004). Four demonstrated non-inferior sensitivity (68-77%, P<= 0.002), three demonstrated noninferior specificity (72-88%, P <= 0.013). Three PSE readers (RAMP-2) were superior for sensitivity. Two PSE readers (RAMP-1) were superior for specificity. Area under the multi-reader receiver operating characteristics curve (0.72) was equal for both modalities. Majority of adverse events followed dipyridamole dosing, and were mild, transient, and required no treatment.
Conclusions Imagify PSE was well-tolerated. Its diagnostic performance in chest pain patients is comparable with SPECT perfusion imaging.
Item Details
| Item Type: | Refereed Article |
|---|---|
| Keywords: | myocardial perfusion; echocardiography; contract echocardiography; stress echocardiography; nuclear imaging |
| Research Division: | Biomedical and Clinical Sciences |
| Research Group: | Cardiovascular medicine and haematology |
| Research Field: | Cardiology (incl. cardiovascular diseases) |
| Objective Division: | Health |
| Objective Group: | Clinical health |
| Objective Field: | Clinical health not elsewhere classified |
| UTAS Author: | Marwick, TH (Professor Tom Marwick) |
| ID Code: | 90806 |
| Year Published: | 2009 |
| Web of Science® Times Cited: | 61 |
| Deposited By: | Menzies Institute for Medical Research |
| Deposited On: | 2014-04-24 |
| Last Modified: | 2022-09-01 |
| Downloads: | 0 |
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