Abstract
BACKGROUND: Although fractional flow reserve (FFR) is the contemporary standard to detect hemodynamically significant coronary stenosis, it remains underused for the need of pressure wire and hyperemic stimulus. Coronary angiography-derived FFR could break through these barriers. The aim of this study was to assess the feasibility and performance of a novel diagnostic modality deriving FFR from invasive coronary angiography (AccuFFRangio) for coronary physiological assessment. METHODS AND RESULTS: The ACCURATE (Angiography-Derived Fractional Flow Reserve for Functional Evaluation of Coronary Artery Disease) study was a prospective, multicenter study conducted at 5 centers. Patients who had at least 1 lesion with a diameter stenosis of 30% to 90% were eligible. AccuFFRangio was measured on site in real time and compared with invasive FFR measurements in a blinded fashion. Primary end point was the diagnostic accuracy of AccuFFRangio in identifying functional relevant lesions. Between November 2020 and June 2021, pairwise analyses of AccuFFRangio and FFR were performed in 304 coronary arteries. AccuFFRangio showed good correlation (r=0.89; P<0.001) and agreement (mean difference: 0.01±0.06) with FFR. The diagnostic accuracy was 95.07% (95% CI, 91.99%-97.21%), which were significantly exceeded the prespecified target value (P<0.001). The sensitivity, specificity, and area under the receiver operating characteristic curve of 95.83% (95% CI, 89.67%-98.85%), 94.71% (95% CI, 90.73%-97.33%), and 0.972 (95% CI, 0.947-0.988), respectively. CONCLUSIONS: AccuFFRangio derived from coronary angiography alone has high diagnostic accuracy, sensitivity, and specificity compared with FFR. AccuFFRangio bears the potential for increasing the adoption of functional assessment of coronary artery stenosis and improving the use of physiological guided decision-making. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04814550.