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Flurpiridaz F-18 PET Imaging in Patients With Suspected CAD
Quick Takes
- Flurpiridaz demonstrated significantly higher sensitivity and specificity for detection of CAD compared with prespecified threshold criteria.
- The diagnostic performance of flurpiridaz PET MPI was shown to be superior to Tc-labeled SPECT MPI for detection of CAD in the overall population as well as in a subset of women and obese patients.
- Additional studies are indicated to establish the added value of flow quantification by flurpiridaz PET compared with currently available PET tracers.
Study Questions:
What is the diagnostic efficacy and safety of flurpiridaz for the detection and evaluation of coronary artery disease (CAD), defined as ≥50% stenosis by quantitative invasive coronary angiography (ICA)?
Methods:
The investigators enrolled 730 patients with suspected CAD from 48 clinical sites in the United States, Canada, and Europe in this second phase 3 prospective multicenter clinical study. Patients underwent 1-day rest/stress flurpiridaz positron emission tomography (PET) and 1- or 2-day rest-stress Tc-99m–labeled single photon emission computed tomography (SPECT) before ICA. Three experts blinded to clinical and ICA data read PET and SPECT images. The primary efficacy endpoints were sensitivity and specificity of flurpiridaz for detection of CAD. Secondary efficacy endpoints included comparison of the diagnostic performance of flurpiridaz PET and SPECT in all patients (key secondary efficacy endpoint) and in women, obese patients, and patients with diabetes. Receiver-operating characteristic curves were generated from logistic regression and were derived from the middle (median) stress defect size and severity (SSS) value of the three readers. Sensitivity versus (1-specificity) was plotted for all possible values of the SSS cutoff criterion defining normal and abnormal.
Results:
A total of 578 patients (ages 63.7 ± 9.5 years) were evaluable; 32.5% were women, 52.3% had body mass index ≥30 kg/m2, and 33.6% had diabetes. Flurpiridaz PET met the efficacy endpoints of the study; its sensitivity and specificity were significantly higher than the prespecified threshold value by two of the three readers. The sensitivity of flurpiridaz PET was higher than SPECT (80.3% vs. 68.7%; p = 0.0003) and its specificity was noninferior to SPECT (63.8% vs. 61.7%; p = 0.0004). PET area under the receiver-operating characteristic curves were higher than SPECT in the overall population (0.80 vs. 0.68; p < 0.001), women, and obese patients (p < 0.001 for both). Flurpiridaz PET was superior to SPECT (p < 0.001) for perfusion defect size/severity evaluation, image quality, diagnostic certainty, and radiation exposure. Flurpiridaz PET was safe and well tolerated.
Conclusions:
The authors report that this imaging trial shows that flurpiridaz has utility as a new tracer for CAD detection, specifically in women and obese patients.
Perspective:
This phase 3 multicenter trial reports that flurpiridaz demonstrated significantly higher sensitivity and specificity for detection of CAD compared with prespecified threshold criteria. Furthermore, the diagnostic performance of flurpiridaz PET myocardial perfusion imaging (MPI) was shown to be superior to Tc-labeled SPECT MPI for detection of CAD in the overall population as well as in a subset of women and obese patients and flurpiridaz PET was superior to SPECT MPI with respect to image quality, confidence of interpretation, and radiation dose to patients. Overall, the data suggest that flurpiridaz has utility as a new tracer for CAD detection, specifically in women and obese patients. Additional studies are indicated to establish the added value of flow quantification by flurpiridaz PET compared with currently available PET tracers.
Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Atherosclerotic Disease (CAD/PAD), Interventions and Coronary Artery Disease, Interventions and Imaging, Computed Tomography, Nuclear Imaging
Keywords: Coronary Artery Disease, Myocardial Perfusion Imaging, Obesity, Positron-Emission Tomography, Single Photon Emission Computed Tomography Computed Tomography
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