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
1 Department of Cardiovascular Medicine, Northwick Park Hospital, Watford Road, Harrow, Middlesex HAI 3UJ, UK
2 King's College Hospital, Denmark Hill, London SE5 9RS, UK
3 Cardiovascular Consultants, Mid America Heart Institute, 4330 Wornall Rd, Kansas City, MO 64111, USA
4 Servicio de Eco-Cardiologia, University Clinic San Carlos, Planta baja Sur. Puerta I, 28040 Madrid, Spain
5 Department of Cardiology, University of Bonn, Sigmund Freudstr. 25, 53105 Bonn, Germany
6 Department of Cardiology, La Sapienza University of Rome, Via del Policlinico 155, 00161 Rome, Italy
7 Cardiovascular Research Institute, 100 Irving St, Washington, DC 20010, USA
8 Cleveland Clinic Foundation, 9500 Euclid Ave, Cleveland, OH 44195, USA
9 University of Queensland/School of Medicine, Level 4, C Wing, Princess Alexandra Hospital, Ipswich Road, Woolloongabba, 4102 QLD, Australia
10 Division of Cardiology, University of Texas, 301 University Blvd, Galveston, TX 77555-0553, USA
11 Cardiology Division, UCSD Med Center, 200 W. Arbor Drive #8411, San Diego, CA 92103, USA
12 University of Texus Health Science Center, 7703 Floyd Curl Drive, San Antonio, TX 78229, USA
13 John Radcliffe Hospital, Headley Way, Oxford 0X3 9DZ, UK
14 OHSU, UHN62, 3181 SW Sam Jackson Park Road, Portland, OR 97239, USA
15 Division of Cardiology, Department of Medicine, Tufts-New England Medical Center, Boston, MA 02111, USA
16 Yale University School of Medicine, 333 Cedar Street Fitkin-3, New Haven, CT 06520, USA
17 Acusphere, Inc, 500 Arsenal Street, Watertown, MA 02472, USA
18 Massachusetts General Hospital, 55 Fruit St, Boston, MA 02114, USA
Received 16 November 2008; accepted after revision 22 November 2008.
* Corresponding author. Middlesex University, London; Imperial College, London; Northwick Park Hospital and Institute of Postgraduate Medical Education and Research. Tel: +44 208 869 2548; fax: +44 208 864 0075. E-mail address: roxysenior{at}cardiac-research.org
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Abstract |
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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 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: Myocardial perfusion; Echocardiography; Contrast echocardiography; Stress echocardiography; Nuclear imaging
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