Comparison of Sulfur Hexafluoride Microbubble (SonoVue)-Enhanced Myocardial Contrast Echocardiography With Gated Single-Photon Emission Computed Tomography for Detection of Significant Coronary Artery Disease

• Published in: Journal of the American College of Cardiology 2013-10, Vol.62 (15), p.1353-1361
• Main Authors: Senior, Roxy, MD, Moreo, Antonella, MD, Gaibazzi, Nicola, MD, Agati, Luciano, MD, Tiemann, Klaus, MD, Shivalkar, Bharati, MD, von Bardeleben, Stephan, MD, Galiuto, Leonarda, MD, Lardoux, Hervé, MD, Trocino, Giuseppe, MD, Carrió, Ignasi, MD, Le Guludec, Dominique, MD, Sambuceti, Gianmario, MD, Becher, Harald, MD, Colonna, Paolo, MD, ten Cate, Folkert, MD, Bramucci, Ezio, MD, Cohen, Ariel, MD, PhD, Bezante, Gianpaolo, MD, Aggeli, Costantina, MD, Kasprzak, Jaroslaw D., MD
• Format: Article
• Language: English
• Subjects: Cardiology; Cardiovascular; contrast echocardiography; Coronary vessels; Electrocardiography; Heart attacks; Internal Medicine; ischemia; Medical imaging; SonoVue
• ISSN: 0735-1097; 1558-3597
• DOI: 10.1016/j.jacc.2013.04.082

Objectives The purpose of this study was to compare sulfur hexafluoride microbubble (SonoVue)-enhanced myocardial contrast echocardiography (MCE) with single-photon emission computed tomography (SPECT) relative to coronary angiography (CA) for assessment of coronary artery disease (CAD). 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, standard99m 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 )