Phase II Safety and Clinical Comparison With Single-Photon Emission Computed Tomography Myocardial Perfusion Imaging for Detection of Coronary Artery Disease Flurpiridaz F 18 Positron Emission Tomography

被引：136

作者：

Berman, Daniel S. ^{[1
,2
]}

Maddahi, Jamshid ^{[3
,4
]}

Tamarappoo, B. K. ^{[1
,2
]}

Czernin, Johannes ^{[3
,4
]}

Taillefer, Raymond ^{[5
]}

Udelson, James E. ^{[6
]}

Gibson, C. Michael ^{[7
]}

Devine, Marybeth ^{[8
]}

Lazewatsky, Joel ^{[8
]}

Bhat, Gajanan ^{[8
]}

Washburn, Dana ^{[8
]}

机构：

[1] Cedars Sinai Med Ctr, Cedars Sinai Heart Inst, Dept Imaging, Los Angeles, CA 90048 USA

[2] Cedars Sinai Med Ctr, Cedars Sinai Heart Inst, Dept Med, Los Angeles, CA 90048 USA

[3] Univ Calif Los Angeles, David Geffen Sch Med, Dept Mol Med, Los Angeles, CA 90095 USA

[4] Univ Calif Los Angeles, David Geffen Sch Med, Dept Pharmacol, Los Angeles, CA 90095 USA

[5] Hop Hotel Dieu Montreal, Montreal, PQ, Canada

[6] Tufts Med Ctr, Div Cardiol & CardioVasc Ctr, Boston, MA USA

[7] Perfuse Study Grp, Boston, MA USA

[8] Lantheus Med Imaging, N Billerica, MA USA

来源：

JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY | 2013年 / 61卷 / 04期

关键词：

flurpiridaz F 18; myocardial perfusion; SPECT; BLOOD-FLOW; PET; TRACER; STENOSIS; STRESS; REST; ECHOCARDIOGRAPHY; N-13-AMMONIA; SEVERITY; TL-201;

D O I：

10.1016/j.jacc.2012.11.022

中图分类号：

R5 [内科学];

学科分类号：

100201 [内科学];

摘要：

Objectives This was a phase II trial to assess flurpiridaz F 18 for safety and compare its diagnostic performance for positron emission tomography (PET) myocardial perfusion imaging (MPI) with Tc-99m single-photon emission computed tomography (SPECT) MPI with regard to image quality, interpretative certainty, defect magnitude, and detection of coronary artery disease (CAD) (>= 50% stenosis) on invasive coronary angiography (ICA). Background In pre-clinical and phase I studies, flurpiridaz F 18 has shown characteristics of an essentially ideal MPI tracer. Methods One hundred forty-three patients from 21 centers underwent rest-stress PET and Tc-99m SPECT MPI. Eighty-six patients underwent ICA, and 39 had low-likelihood of CAD. Images were scored by 3 independent, blinded readers. Results A higher percentage of images were rated as excellent/good on PET versus SPECT on stress (99.2% vs. 88.5%, p < 0.01) and rest (96.9% vs. 66.4, p < 0.01) images. Diagnostic certainty of interpretation (percentage of cases with definitely abnormal/normal interpretation) was higher for PET versus SPECT (90.8% vs. 70.9%, p < 0.01). In 86 patients who underwent ICA, sensitivity of PET was higher than SPECT (78.8% vs. 61.5%, respectively, p < 0.02). Specificity was not significantly different (PET: 76.5% vs. SPECT: 73.5%). Receiver-operating characteristic curve area was 0.82 +/- 0.05 for PET and 0.70 +/- 0.06 for SPECT (p = 0.04). Normalcy rate was 89.7% with PET and 97.4% with SPECT (p = NS). In patients with CAD on ICA, the magnitude of reversible defects was greater with PET than SPECT (p = 0.008). Extensive safety assessment revealed that flurpiridaz F 18 was safe in this cohort. Conclusions In this phase 2 trial, PET MPI with flurpiridaz F 18 was safe and superior to SPECT MPI for image quality, interpretative certainty, and overall CAD diagnosis. (J Am Coll Cardiol 2013;61:469-77) (C) 2013 by the American College of Cardiology Foundation

引用

页码：469 / 477

页数：9

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