2. Academic Validation
  3. Flurpiridaz F-18 PET Myocardial Perfusion Imaging in Patients With Suspected Coronary Artery Disease

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.
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
Affiliations

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.

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