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

Roxy Senior, Mark Monaghan, Michael L. Main, Jose L. Zamorano, Klaus Tiemann, Luciano Agati, Neil J. Weissman, Allan L. Klein, Thomas H. Marwick, Masood Ahmad, Anthony N. DeMaria, Miguel Zabalgoitia, Harald Becher, Sanjiv Kaul, James E. Udelson, Frans J. Wackers, Richard C. Walovitch, Michael H. Picard

    Research output: Contribution to journalArticle

    53 Citations (Scopus)

    Abstract

    Aims: To determine if perfusion stress echocardiography (PSE) with Imagify™ (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 non-inferior 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.

    Original languageEnglish (US)
    Pages (from-to)26-35
    Number of pages10
    JournalEuropean Journal of Echocardiography
    Volume10
    Issue number1
    DOIs
    StatePublished - Jan 2009

    Fingerprint

    Stress Echocardiography
    Perfusion Imaging
    Radionuclide Imaging
    Coronary Artery Disease
    Ultrasonography
    Perfusion
    Single-Photon Emission-Computed Tomography
    Dipyridamole
    Chest Pain

    Keywords

    • Contrast echocardiography
    • Echocardiography
    • Myocardial perfusion
    • Nuclear imaging
    • Stress echocardiography

    ASJC Scopus subject areas

    • Cardiology and Cardiovascular Medicine
    • Radiology Nuclear Medicine and imaging

    Cite this

    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. / Senior, Roxy; Monaghan, Mark; Main, Michael L.; Zamorano, Jose L.; Tiemann, Klaus; Agati, Luciano; Weissman, Neil J.; Klein, Allan L.; Marwick, Thomas H.; Ahmad, Masood; DeMaria, Anthony N.; Zabalgoitia, Miguel; Becher, Harald; Kaul, Sanjiv; Udelson, James E.; Wackers, Frans J.; Walovitch, Richard C.; Picard, Michael H.

    In: European Journal of Echocardiography, Vol. 10, No. 1, 01.2009, p. 26-35.

    Research output: Contribution to journalArticle

    Senior, R, Monaghan, M, Main, ML, Zamorano, JL, Tiemann, K, Agati, L, Weissman, NJ, Klein, AL, Marwick, TH, Ahmad, M, DeMaria, AN, Zabalgoitia, M, Becher, H, Kaul, S, Udelson, JE, Wackers, FJ, Walovitch, RC & Picard, MH 2009, '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, vol. 10, no. 1, pp. 26-35. https://doi.org/10.1093/ejechocard/jen321
    Senior, Roxy ; Monaghan, Mark ; Main, Michael L. ; Zamorano, Jose L. ; Tiemann, Klaus ; Agati, Luciano ; Weissman, Neil J. ; Klein, Allan L. ; Marwick, Thomas H. ; Ahmad, Masood ; DeMaria, Anthony N. ; Zabalgoitia, Miguel ; Becher, Harald ; Kaul, Sanjiv ; Udelson, James E. ; Wackers, Frans J. ; Walovitch, Richard C. ; Picard, Michael H. / 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. In: European Journal of Echocardiography. 2009 ; Vol. 10, No. 1. pp. 26-35.
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    abstract = "Aims: To determine if perfusion stress echocardiography (PSE) with Imagify™ (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 non-inferior 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.",
    keywords = "Contrast echocardiography, Echocardiography, Myocardial perfusion, Nuclear imaging, Stress echocardiography",
    author = "Roxy Senior and Mark Monaghan and Main, {Michael L.} and Zamorano, {Jose L.} and Klaus Tiemann and Luciano Agati and Weissman, {Neil J.} and Klein, {Allan L.} and Marwick, {Thomas H.} and Masood Ahmad and DeMaria, {Anthony N.} and Miguel Zabalgoitia and Harald Becher and Sanjiv Kaul and Udelson, {James E.} and Wackers, {Frans J.} and Walovitch, {Richard C.} and Picard, {Michael H.}",
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    T1 - Detection of coronary artery disease with perfusion stress echocardiography using a novel ultrasound imaging agent

    T2 - Two Phase 3 international trials in comparison with radionuclide perfusion imaging

    AU - Senior, Roxy

    AU - Monaghan, Mark

    AU - Main, Michael L.

    AU - Zamorano, Jose L.

    AU - Tiemann, Klaus

    AU - Agati, Luciano

    AU - Weissman, Neil J.

    AU - Klein, Allan L.

    AU - Marwick, Thomas H.

    AU - Ahmad, Masood

    AU - DeMaria, Anthony N.

    AU - Zabalgoitia, Miguel

    AU - Becher, Harald

    AU - Kaul, Sanjiv

    AU - Udelson, James E.

    AU - Wackers, Frans J.

    AU - Walovitch, Richard C.

    AU - Picard, Michael H.

    PY - 2009/1

    Y1 - 2009/1

    N2 - Aims: To determine if perfusion stress echocardiography (PSE) with Imagify™ (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 non-inferior 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.

    AB - Aims: To determine if perfusion stress echocardiography (PSE) with Imagify™ (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 non-inferior 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.

    KW - Contrast echocardiography

    KW - Echocardiography

    KW - Myocardial perfusion

    KW - Nuclear imaging

    KW - Stress echocardiography

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