Flurpiridaz F-18 PET demonstrated higher sensitivity (80.3% vs 68.7%; P=0.0003) and noninferior specificity (63.8% vs 61.7%; P=0.0004) compared to SPECT for detecting coronary artery disease.
RCT (n=578)
Blinded
Yes
Does flurpiridaz F-18 PET improve diagnostic accuracy for detecting CAD compared to Tc-99m SPECT in patients with suspected CAD?
Flurpiridaz F-18 PET provides superior sensitivity and noninferior specificity compared to Tc-99m SPECT for detecting coronary artery disease, particularly in women and obese patients.
Absolute Event Rate: 80.3% vs 68.7%
p-value: p=0.0003
BACKGROUND Flurpiridaz F-18 (flurpiridaz) is a novel positron emission tomography (PET) myocardial perfusion imaging tracer. OBJECTIVES The purpose of this study was to further assess 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 In this second phase 3 prospective multicenter clinical study, 730 patients with suspected CAD from 48 clinical sites in the United States, Canada, and Europe were enrolled. Patients underwent 1-day rest/stress flurpiridaz PET and 1- or 2-day rest-stress Tc-99m-labeled single photon emission computed tomography (SPECT) before ICA. PET and SPECT images were read by 3 experts blinded to clinical and ICA data. RESULTS A total of 578 patients (age 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 2 of the 3 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 This second flurpiridaz PET myocardial perfusion imaging trial shows that flurpiridaz has utility as a new tracer for CAD detection, specifically in women and obese patients. (An International Study to Evaluate Diagnostic Efficacy of Flurpiridaz 18F Injection PET MPI in the Detection of Coronary Artery Disease CAD; NCT03354273).
“This could be a paradigm shift. With flurpiridaz, we have a radiotracer that not only surpasses SPECT in terms of diagnostic performance but also offers enhanced confidence for clinicians. This is a long-awaited development in nuclear cardiology, and I believe it will lead to much greater use of PET in the diagnosis and management of heart disease.”
Maddahi et al. (Sun,) conducted a rct in Suspected coronary artery disease (n=578). Flurpiridaz F-18 PET vs. Tc-99m-labeled SPECT was evaluated on Sensitivity for the detection of coronary artery disease defined as ≥50% stenosis by quantitative invasive coronary angiography (p=0.0003). Flurpiridaz F-18 PET demonstrated higher sensitivity (80.3% vs 68.7%; P=0.0003) and noninferior specificity (63.8% vs 61.7%; P=0.0004) compared to SPECT for detecting coronary artery disease.