Flurpiridaz F-18 PET Myocardial Perfusion Imaging in Patients With Suspected Coronary Artery Disease
Key result
Flurpiridaz F-18 PET outperforms SPECT for detecting CAD, delivering ~80% sensitivity and noninferior specificity.
- P=0.0003
- n=578
Journal of the American College of Cardiology published a graphical abstract
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Why the study?
The study was designed to further evaluate the diagnostic efficacy and safety of flurpiridaz F-18 PET myocardial perfusion imaging for detecting CAD defined as ≥50% stenosis by quantitative ICA.
Does flurpiridaz F-18 PET improve diagnostic accuracy for detecting CAD compared to Tc-99m SPECT in patients with suspected CAD?
Key Points
- This study investigates the diagnostic efficacy and safety of flurpiridaz PET in detecting ≥50% stenosis from coronary artery disease.
- Phase 3 prospective multicenter clinical study with 730 patients across 48 sites in North America and Europe.
- Patients underwent 1-day rest/stress flurpiridaz PET and SPECT before invasive coronary angiography.
- Imaging results were analyzed by three experts blinded to clinical and invasive coronary outcomes.
- Flurpiridaz PET demonstrated sensitivity of 80.3% (higher than SPECT at 68.7%; P=0.0003).
- Specificity of flurpiridaz PET was noninferior at 63.8% versus 61.7% for SPECT (P=0.0004).
- Flurpiridaz PET outperformed SPECT in diagnostic quality, radiation exposure, and evaluation of perfusion defect size compared with Tc-99m SPECT (P<0.001 for all).
Study Design
Type
RCT (n=578)
Blinding
Blinded
Multicenter
Yes
Structured PICO
Does flurpiridaz F-18 PET improve diagnostic accuracy for detecting CAD compared to Tc-99m SPECT in patients with suspected CAD?
P
Population
578 evaluable patients (mean age 63.7 years, 32.5% women) with suspected coronary artery disease who underwent both flurpiridaz PET and Tc-99m SPECT before invasive coronary angiography.
I
Intervention
1-day rest/stress flurpiridaz F-18 PET myocardial perfusion imaging
C
Comparator
1- or 2-day rest-stress Tc-99m-labeled single photon emission computed tomography (SPECT)
O
Outcome
Diagnostic efficacy (sensitivity and specificity) for the detection and evaluation of coronary artery disease (CAD) defined as ≥50% stenosis by quantitative invasive coronary angiography (ICA)surrogate
Main Result
Absolute Event Rate: 80.3% vs 68.7%
p-value: p=0.0003
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.
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Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“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.”
“Image quality is much, much better, confidence of interpretation is much higher, and also quantitation of myocardial blood flow is optimal with this tracer. But that also means that physicians have to learn how to appropriately interpret the findings from the enhanced images.”
“Multiple phase II and two phase III clinical trials have further established the utility of 18F-flurpiridaz as a valuable PET radiotracer for the non-invasive evaluation of CAD. Owing to its favorable molecular imaging characteristics and extended half-life, 18F-flurpiridaz is poised to become a valuable agent for cardiac stress PET imaging, offering clinicians a robust tool for the evaluation of CAD.”
Implication
Flurpiridaz PET may enhance CAD detection sensitivity versus SPECT; leaves open effects on outcomes and routine adoption.
Abstract
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).
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Cite This Study
Maddahi et al. (2023) conducted an 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.