A1 Vertaisarvioitu alkuperäisartikkeli tieteellisessä lehdessä
Improved assessment of coronary artery disease in obese Patients with flurpiridaz-18F positron emission tomography myocardial perfusion imaging: A prespecified subgroup analysis of the AURORA phase 3 study
Tekijät: Patel, Krishna K.; Maddahi, Jamshid; Agostini, Denis; Bax, Jeroen J.; Beanlands, Rob S.B.; Berman, Daniel; Dorbala, Sharmila; Heller, Gary V.; Knuuti, Juhani M.; Pelletier-Galarneau, Matthieu; Tamaki, Nagara; Thompson, David; Somer, Edward J.; Udelson, James E.; Bateman, Timothy M.
Kustantaja: Elsevier
Julkaisuvuosi: 2026
Lehti: Journal of Nuclear Cardiology
Artikkelin numero: 102741
Vuosikerta: 61
ISSN: 1071-3581
eISSN: 1532-6551
DOI: https://doi.org/10.1016/j.nuclcard.2026.102741
Julkaisun avoimuus kirjaamishetkellä: Ei avoimesti saatavilla
Julkaisukanavan avoimuus : Osittain avoin julkaisukanava
Verkko-osoite: https://doi.org/10.1016/j.nuclcard.2026.102741
Background: Noninvasive assessment of coronary artery disease (CAD) in obese patients is challenging due to suboptimal image quality. We performed a prespecified secondary analysis of obese patients from the second Phase III trial of flurpiridaz-18F positron emission tomography (PET).
Methods: In total, 604 patients with suspected CAD underwent flurpiridaz-18F PET and 99mTc-single-photon emission computerized tomography (SPECT) myocardial perfusion imaging (MPI) before invasive coronary angiography (ICA) across 48 sites. MPI images were interpreted by three blinded experts. The primary endpoint was sensitivity and specificity for diagnosing CAD (≥50% stenosis on quantitative coronary angiography), requiring the lower 95% confidence interval to exceed 60% by 2 same blinded expert core lab readers, assessed using one-sided z-test (α = 0.025). Sensitivity and specificity were compared between PET and SPECT and between obese (body mass index [BMI] ≥30 kg/m2) and nonobese patients.
Results: Of 578 evaluable patients, 298 (51.6%) were obese (mean age: 62.0 years, 64.4% male, mean BMI: 35.6 kg/m2) and 117 (39.3%) had CAD by ICA. In obese patients, flurpiridaz-18F PET MPI met the primary endpoint, with lower 95% confidence limits greater than 60% and one-sided P < 0.025 by the same 2 readers (Readers 1 and 2). Sensitivity across 3 readers ranged from 70.1% to 88.0% and specificity ranged from 53.6% to 74.0%. In obese patients, flurpiridaz-18F PET MPI showed significantly higher sensitivity compared to 99ᵐTc-SPECT MPI by Readers 1 and 3 (Reader 1: 72.6% vs 60.7%, P = 0.01; Reader 3: 88.0% vs 74.4%, P = 0.002), with non-inferior specificity by the same two readers (Reader 1: 68.0% vs 61.3%; Reader 3: 53.6% vs 50.8%; P < 0.01 for noninferiority, for both), noting that the primary endpoint was met by a partially overlapping reader pair (Readers 1 and 2). Diagnostic performance of flurpiridaz-18F PET was higher than SPECT across BMI categories. No statistically significant difference in diagnostic performance was observed between obese and nonobese patients (Sensitivity P = 0.26, specificity P = 0.25 and accuracy P = 1.0).
Conclusion: Flurpiridaz-18F PET MPI demonstrates high diagnostic efficacy for detecting CAD across BMI categories in obese patients compared to ICA and 99mTc-SPECT, with no loss of diagnostic performance in obese relative to nonobese patients.
Clinical trial registration: NCT03354273.
Keywords: Cardiac PET; Coronary artery disease; F-18 flurpiridaz; Myocardial perfusion imaging; Obesity; Radiotracers.
Avainsanat:
cardiac PET, coronary artery disease, F-18 flurpiridaz, myocardial perfusion imaging, obesity, Radiotracers
Julkaisussa olevat rahoitustiedot:
The AURORA study and data analyses were funded by GE Healthcare Ltd and its Affiliates, Chalfont St Giles, United Kingdom. No specific funding was provided to the authors for this subgroup analysis.
