Abstract | OBJECTIVES: BACKGROUND: Small-scale studies have shown that myocardial perfusion assessed by SonoVue-enhanced MCE is a viable alternative to SPECT for CAD assessment. However, large multicenter studies are lacking. METHODS: Patients referred for myocardial ischemia testing at 34 centers underwent rest/ vasodilator SonoVue-enhanced flash-replenishment MCE, standard (99m)Tc-labeled electrocardiography-gated SPECT, and quantitative CA within 1 month. Myocardial ischemia assessments by 3 independent, blinded readers for MCE and 3 readers for SPECT were collapsed into 1 diagnosis per patient per technique and were compared to CA (reference standard) read by 1 independent blinded reader. RESULTS: Of 628 enrolled patients who received SonoVue (71% males; mean age: 64 years; >1 cardiovascular [CV] risk factor in 99% of patients) 516 patients underwent all 3 examinations, of whom 161 (31.2%) had ≥70% stenosis (131 had single-vessel disease [SVD]; 30 had multivessel disease), and 310 (60.1%) had ≥50% stenosis. Higher sensitivity was obtained with MCE than with SPECT (75.2% vs. 49.1%, respectively; p < 0.0001), although specificity was lower (52.4% vs. 80.6%, respectively; p < 0.0001) for ≥70% stenosis. Similar findings were obtained for patients with ≥50% stenosis. Sensitivity levels for detection of SVD and proximal disease for ≥70% stenosis were higher for MCE (72.5% vs. 42.7%, respectively; p < 0.0001; 80% vs. 58%, respectively; p = 0.005, respectively). CONCLUSIONS:
SonoVue-enhanced MCE demonstrated superior sensitivity but lower specificity for detection of CAD compared to SPECT in a population with a high incidence of CV risk factors and intermediate-high prevalence of CAD. (A phase III study to compare SonoVue® enhanced myocardial echocardiography [MCE] to single photon emission computerized tomography [ECG-GATED SPECT], at rest and at peak of low-dose Dipyridamole stress test, in the assessment of significant coronary artery disease [CAD] in patients with suspect or known CAD using Coronary Angiography as Gold Standard- SonoVue MCE vs SPECT; EUCTR2007-003492-39-GR).
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Authors | Roxy Senior, Antonella Moreo, Nicola Gaibazzi, Luciano Agati, Klaus Tiemann, Bharati Shivalkar, Stephan von Bardeleben, Leonarda Galiuto, Hervé Lardoux, Giuseppe Trocino, Ignasi Carrió, Dominique Le Guludec, Gianmario Sambuceti, Harald Becher, Paolo Colonna, Folkert Ten Cate, Ezio Bramucci, Ariel Cohen, Gianpaolo Bezante, Costantina Aggeli, Jaroslaw D Kasprzak |
Journal | Journal of the American College of Cardiology
(J Am Coll Cardiol)
Vol. 62
Issue 15
Pg. 1353-61
(Oct 08 2013)
ISSN: 1558-3597 [Electronic] United States |
PMID | 23770168
(Publication Type: Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved. |
Chemical References |
- Contrast Media
- Technetium Tc 99m Sestamibi
- Sulfur Hexafluoride
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Topics |
- Contrast Media
- Coronary Angiography
- Coronary Artery Disease
(diagnosis)
- Coronary Stenosis
(diagnosis)
- Echocardiography
(methods)
- Electrocardiography
- Europe
- Female
- Humans
- Image Enhancement
(methods)
- Male
- Microbubbles
- Middle Aged
- Prospective Studies
- Sensitivity and Specificity
- Sulfur Hexafluoride
- Technetium Tc 99m Sestamibi
- Tomography, Emission-Computed, Single-Photon
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