title: Phase II safety and clinical comparison with single-photon emission computed tomography myocardial perfusion imaging for detection of coronary artery disease: flurpiridaz F 18 positron emission tomography.
abstract: OBJECTIVE
  This was a phase II trial to assess flurpiridaz F 18 for safety and compare its diagnostic performance for positron emission tomography (PET) myocardial perfusion imaging (MPI) with Tc-99m single-photon emission computed tomography (SPECT) MPI with regard to image quality, interpretative certainty, defect magnitude, and detection of coronary artery disease (CAD) (≥50% stenosis) on invasive coronary angiography (ICA).
  
  
  BACKGROUND
  In pre-clinical and phase I studies, flurpiridaz F 18 has shown characteristics of an essentially ideal MPI tracer.
  
  
  METHODS
  One hundred forty-three patients from 21 centers underwent rest-stress PET and Tc-99m SPECT MPI. Eighty-six patients underwent ICA, and 39 had low-likelihood of CAD. Images were scored by 3 independent, blinded readers.
  
  
  RESULTS
  A higher percentage of images were rated as excellent/good on PET versus SPECT on stress (99.2% vs. 88.5%, p < 0.01) and rest (96.9% vs. 66.4, p < 0.01) images. Diagnostic certainty of interpretation (percentage of cases with definitely abnormal/normal interpretation) was higher for PET versus SPECT (90.8% vs. 70.9%, p < 0.01). In 86 patients who underwent ICA, sensitivity of PET was higher than SPECT (78.8% vs. 61.5%, respectively, p = 0.02). Specificity was not significantly different (PET: 76.5% vs. SPECT: 73.5%). Receiver-operating characteristic curve area was 0.82 ± 0.05 for PET and 0.70 ± 0.06 for SPECT (p = 0.04). Normalcy rate was 89.7% with PET and 97.4% with SPECT (p = NS). In patients with CAD on ICA, the magnitude of reversible defects was greater with PET than SPECT (p = 0.008). Extensive safety assessment revealed that flurpiridaz F 18 was safe in this cohort.
  
  
  CONCLUSIONS
  In this phase 2 trial, PET MPI with flurpiridaz F 18 was safe and superior to SPECT MPI for image quality, interpretative certainty, and overall CAD diagnosis.
authors.affiliation: Departments of Imaging and Medicine, the Cedars-Sinai Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California. Electronic address: bermand@cshs.org.
authors.forename: Daniel S
authors.initials: DS
authors.lastname: Berman
authors.affiliation: Departments of Molecular Medicine and Pharmacology, David Geffen School of Medicine at UCLA, Los Angeles, California.
authors.forename: Jamshid
authors.initials: J
authors.lastname: Maddahi
authors.affiliation: Departments of Imaging and Medicine, the Cedars-Sinai Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California.
authors.forename: B K
authors.initials: BK
authors.lastname: Tamarappoo
authors.affiliation: Departments of Molecular Medicine and Pharmacology, David Geffen School of Medicine at UCLA, Los Angeles, California.
authors.forename: Johannes
authors.initials: J
authors.lastname: Czernin
authors.affiliation: Hôpital Hôtel-Dieu de Montréal, Montréal, Quebec, Canada.
authors.forename: Raymond
authors.initials: R
authors.lastname: Taillefer
authors.affiliation: Division of Cardiology and the CardioVascular Center, Tufts Medical Center, Boston, Massachusetts.
authors.forename: James E
authors.initials: JE
authors.lastname: Udelson
authors.affiliation: Perfuse Study Group, Boston, Massachusetts.
authors.forename: C Michael
authors.initials: CM
authors.lastname: Gibson
authors.affiliation: Lantheus Medical Imaging, North Billerica, Massachusetts.
authors.forename: Marybeth
authors.initials: M
authors.lastname: Devine
authors.affiliation: Lantheus Medical Imaging, North Billerica, Massachusetts.
authors.forename: Joel
authors.initials: J
authors.lastname: Lazewatsky
authors.affiliation: Lantheus Medical Imaging, North Billerica, Massachusetts.
authors.forename: Gajanan
authors.initials: G
authors.lastname: Bhat
authors.affiliation: Lantheus Medical Imaging, North Billerica, Massachusetts.
authors.forename: Dana
authors.initials: D
authors.lastname: Washburn
mesh_terms: D017023:Coronary Angiography / Q000379:methods; D003324:Coronary Artery Disease / Q000175:diagnosis*; D003326:Coronary Circulation; D005080:Exercise Test; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D055414:Myocardial Perfusion Imaging / Q000009:adverse effects / Q000379:methods; D049268:Positron-Emission Tomography / Q000009:adverse effects / Q000379:methods; D011724:Pyridazines; D012372:ROC Curve; D019275:Radiopharmaceuticals; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D017256:Technetium Tc 99m Sestamibi; D015899:Tomography, Emission-Computed, Single-Photon / Q000009:adverse effects / Q000379:methods
chemical_list: C525920:BMS 747158-02; D011724:Pyridazines; D019275:Radiopharmaceuticals; D017256:Technetium Tc 99m Sestamibi