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.
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.
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DOI：
10.1016/j.jacc.2012.11.022
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发表时间：
2013-01-29
影响因子：
24
通讯作者：
Washburn, Dana
中科院分区：
文献类型：
--
作者：
Berman, Daniel S.;Maddahi, Jamshid;Tamarappoo, B. K.;Czernin, Johannes;Taillefer, Raymond;Udelson, James E.;Gibson, C. Michael;Devine, Marybeth;Lazewatsky, Joel;Bhat, Gajanan;Washburn, Dana
II期试验，旨在评估氟吡达兹F 18的安全性，并比较其在PET心肌灌注成像（MPI）与Tc-99 m SPECT-MPI中的诊断性能，包括图像质量、解释确定性、缺陷程度和有创冠状动脉造影（伊卡）中冠状动脉疾病（CAD）（≥ 50%狭窄）的检测。在临床前和I期研究中，氟吡达兹F 18显示出基本上理想的MPI示踪剂的特征。来自21个中心的143名患者接受了静息负荷PET和Tc-99 m SPECT-MPI。86例患者接受了伊卡，39例患者的CAD可能性较低。由3名独立的盲法阅片员对图像进行评分。PET与SPECT在负荷（99.2% vs. 88.5%，p<0.01）和静息（96.9% vs. 66.4，p<0.01）图像上的图像被评定为优/良的百分比更高。PET与SPECT的诊断解释确定性（明确异常/正常解释的病例%）更高（90.8% vs. 70.9%，p<0.01）。在86例接受伊卡的患者中，PET的灵敏度高于SPECT [分别为78.8%和61.5%（p=0.02）]。特异性无显著差异（PET：76.5% vs. SPECT：73.5%）。PET和SPECT的受试者工作特征曲线面积分别为0.82±0.05和0.70±0.06（p=0.04）。PET和SPECT的正常率分别为89.7%和97.4%（p=NS）。在伊卡上的CAD患者中，PET的可逆性缺损程度大于SPECT（p=0.008）。广泛的安全性评估显示，氟吡哒唑F18在该队列中是安全的。在这项II期试验中，使用氟吡达兹F 18的PET MPI是安全的，并且在图像质量、解释确定性和总体CAD诊断方面优于SPECT MPI上级。
Phase II trial to assess flurpiridaz F 18 for safety and compare its diagnostic performance for PET myocardial perfusion imaging (MPI) to Tc-99m SPECT-MPI regarding image quality, interpretative certainty, defect magnitude and detection of coronary artery disease (CAD)(≥ 50% stenosis) on invasive coronary angiography (ICA). In preclinical and phase I studies, flurpiridaz F 18 has shown characteristics of an essentially ideal MPI tracer. 143 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. A higher % of images were rated as excellent/good on PET vs. 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 (% cases with definitely abnormal/normal interpretation) was higher for PET vs. 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. In this Phase 2 trial, PET MPI using flurpiridaz F 18 was safe and superior to SPECT MPI for image quality, interpretative certainty, and overall CAD diagnosis.
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