Diagnostic Performance of Fractional Flow Reserve Derived From Coronary CT Angiography: The ACCURATE-CT Study.

ABSTRACT

BACKGROUND: ArteryFlow Technology (AccuFFRct) is a novel noninvasive method for calculating fractional flow reserve (FFR) from coronary computed tomography angiography (CCTA). The accuracy of AccuFFRct has not been adequately assessed. OBJECTIVES: This study sought to evaluate the diagnostic performance of AccuFFRct in detecting lesion-specific ischemia. METHODS: This prospective study enrolled 339 patients with 404 vessels. CCTA-derived FFR was calculated using an on-site computational fluid dynamics-based method and compared with invasive FFR. The performance of AccuFFRct was comprehensively analyzed in all lesions and subgroups, including "gray zone" lesions, various lesion classifications, clinical presentations, stenosis severities, and lesion locations. RESULTS: Using FFR ≤0.80 as a reference standard, the overall diagnostic accuracy, sensitivity, specificity, positive predictive value, and negative predictive value for AccuFFRct were 90.6% (95% CI 87.3%-93.3%), 90.9% (95% CI 85.1%-94.9%), 90.4% (95% CI 86.1%-93.8%), 85.3% (95% CI 79.8%-89.5%), and 94.2% (95% CI 90.8%-96.4%), respectively. Good correlation and agreement were found between the computed AccuFFRct and measured FFR. AccuFFRct showed superior discrimination ability to CCTA (AUC 0.93 [95% CI 0.89-0.95] vs 0.77 [95% CI 0.72-0.81]; P < 0.001) and quantitative coronary angiography (AUC 0.93 [95% CI 0.89-0.95] vs 0.89 [95% CI 0.85-0.92]; P = 0.048) for identifying functionally significant stenosis. Notably, AccuFFRct maintained high diagnostic accuracy across the spectrum of lesion classifications, clinical presentations, stenosis severities, lesion locations, and in the gray zone. Furthermore, in the cohort with ≥70% stenosis, AccuFFRct could significantly reduce the rate of un-necessary invasive tests (33.1% vs 6.6%; P < 0.001). CONCLUSIONS: The study confirms the potential of AccuFFRct as a noninvasive alternative to invasive FFR for detecting ischemia in coronary artery disease and to risk stratify patients. The results highlight AccuFFRct's robust diagnostic ability across a wide range of lesion classifications, clinical presentations, stenosis severities, lesion locations, and in the gray zone. (Diagnostic Performance of Fractional Flow Reserve Derived From Coronary CT Angiography [ACCURATE-CT]; NCT04426396).