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Clinical Trial
. 2023 Oct 17;82(16):1598-1610.
doi: 10.1016/j.jacc.2023.08.016.

Flurpiridaz F-18 PET Myocardial Perfusion Imaging in Patients With Suspected Coronary Artery Disease

Jamshid Maddahi  1 , Denis Agostini  2 , Timothy M Bateman  3 , Jeroen J Bax  4 , Rob S B Beanlands  5 , Daniel S Berman  6 , Sharmila Dorbala  7 , Ernest V Garcia  8 , James Feldman  9 , Gary V Heller  10 , Juhani M Knuuti  11 , Pedro Martinez-Clark  12 , Matthieu Pelletier-Galarneau  13 , Benjamin Shepple  14 , Nagara Tamaki  15 , Francois Tranquart  16 , James E Udelson  17
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Free article
Clinical Trial

Flurpiridaz F-18 PET Myocardial Perfusion Imaging in Patients With Suspected Coronary Artery Disease

Jamshid Maddahi et al. J Am Coll Cardiol. .
Free article

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).

Keywords: coronary artery disease; flurpiridaz; myocardial perfusion imaging; phase 3 PET trial; positron emission tomography.

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Conflict of interest statement

Funding Support and Author Disclosures This study was funded by GE Healthcare Ltd and its Affiliates, Chalfont St Giles, United Kingdom. Drs Bax, Dorbala, Garcia, Heller, Tamaki, and Udelson have served as a consultant to GE Healthcare Ltd and its Affiliates. Drs Maddahi, Agostini, Bateman, Beanlands, Berman, and Knuuti have served as a consultant to and received a research grant from GE Healthcare Ltd and its Affiliates. Dr Beanlands has served as a consultant for and received research grants from Lantheus Medical Imaging and Jubilant DraxImage. Drs Feldman, Martinez-Clark, Pelletier-Galarneau, and Shepple have received a research grant from GE Healthcare Ltd and its Affiliates. Dr Tranquart is an employee and Global Head of Development of GE Healthcare Ltd and its Affiliates.

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