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 Academic Article uri icon

abstract

  • AIMS: To determine if perfusion stress echocardiography (PSE) with Imagify (perflubutane polymer microspheres) is comparable to stress perfusion imaging using (99m)Tc 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

authors

  • 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

publication date

  • January 1, 2009

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