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

Jamshid Maddahi; Denis Agostini; Timothy M Bateman; Jeroen J Bax; Rob S B Beanlands; Daniel S Berman; Sharmila Dorbala; Ernest V Garcia; James Feldman; Gary V Heller; Juhani M Knuuti; Pedro Martinez-Clark; Matthieu Pelletier-Galarneau; Benjamin Shepple; Nagara Tamaki; Francois Tranquart; James E Udelson

doi:10.1016/j.jacc.2023.08.016

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

J Am Coll Cardiol. 2023 Oct 17;82(16):1598-1610. doi: 10.1016/j.jacc.2023.08.016.

Authors

Jamshid Maddahi¹, Denis Agostini², Timothy M Bateman³, Jeroen J Bax⁴, Rob S B Beanlands⁵, Daniel S Berman⁶, Sharmila Dorbala⁷, Ernest V Garcia⁸, James Feldman⁹, Gary V Heller¹⁰, Juhani M Knuuti¹¹, Pedro Martinez-Clark¹², Matthieu Pelletier-Galarneau¹³, Benjamin Shepple¹⁴, Nagara Tamaki¹⁵, Francois Tranquart¹⁶, James E Udelson¹⁷

Affiliations

¹ Department of Molecular and Medical Pharmacology (Nuclear Medicine), David Geffen School of Medicine at University of California, Los Angeles, Los Angeles, California, USA; Department of Medicine (Cardiology), David Geffen School of Medicine at University of California, Los Angeles, Los Angeles, California, USA. Electronic address: jmaddahi@gmail.com.
² University Hospital Caen, Caen, France.
³ Mid-America Heart, Kansas City, Kansas, USA.
⁴ University of Leiden, Leiden, the Netherlands.
⁵ Division of Cardiology, Department of Medicine, University of Ottawa Heart Institute, Ottawa, Ontario, Canada.
⁶ Cedars Sinai Medical Center, Los Angeles, California, USA.
⁷ Brigham and Women's Hospital, Boston, Massachusetts, USA.
⁸ Emory University, Atlanta, Georgia, USA.
⁹ Memorial City and Katy Cardiology, Katy, Texas, USA.
¹⁰ Morristown Medical Center, Morristown, New Jersey, USA.
¹¹ Turku University, Turku, Finland.
¹² Amavita Heart and Vascular Health, North Miami Beach, Florida, USA.
¹³ Montreal Heart Institute, Montreal, Quebec, Canada.
¹⁴ University of Tennessee Medical Center, Knoxville, Tennessee, USA.
¹⁵ Kyoto Prefectural University of Medicine, Kyoto, Japan.
¹⁶ GE Healthcare Ltd and its Affiliates, Chalfont St Giles, United Kingdom.
¹⁷ Tufts Medical Center, Boston, Massachusetts, USA.

PMID: 37821170
DOI: 10.1016/j.jacc.2023.08.016

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.

Publication types

Clinical Trial, Phase III
Multicenter Study
Research Support, Non-U.S. Gov't

MeSH terms

Aged
Arteries
Coronary Angiography / methods
Coronary Artery Disease* / diagnostic imaging
Female
Humans
Male
Middle Aged
Myocardial Perfusion Imaging* / methods
Obesity
Positron-Emission Tomography / methods
Prospective Studies
Radiopharmaceuticals / pharmacology
Tomography, Emission-Computed, Single-Photon / methods

Substances

Radiopharmaceuticals

Associated data

ClinicalTrials.gov/NCT03354273