Clinical Research
Cardiac Imaging
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

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Objectives

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.

Key Words

flurpiridaz F 18
myocardial perfusion
SPECT

Abbreviations and Acronyms

AE
adverse event
CAD
coronary artery disease
CT
computed tomography
F-18
fluorine-18
ICA
invasive coronary angiography
MI
myocardial infarction
MPI
myocardial perfusion imaging
PCI
percutaneous coronary intervention
PET
positron emission tomography
QCA
quantitative coronary angiography
ROC
receiver-operating characteristic
SDS
summed different score
SPECT
single-photon emission computed tomography
SRS
summed rest score
SSS
summed stress score

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Dr. Tamarappoo is currently at the Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio. Dr. Maddahi has served as consultant to Lantheus Medical Imaging, Digirad, and Astellas; served on the Speakers' Bureau for Astellas; and contracted research with Lantheus Medical Imaging. Dr. Taillefer has served as consultant to and as a member of the scientific advisory board of Lantheus Medical Imaging. Dr. Gibson has received research grant funding from Lantheus Medical Imaging. Ms. Devine is an employee of Avid Radiopharmaceuticals. Drs. Bhat, Lazewatsky, and Washburn are employees of Lantheus Medical Imaging. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.