Diagnostic performance of AccuFFRangio in the functional assessment of coronary stenosis compared with pressure wire-derived fractional flow reserve.

Background: Non-invasive fractional flow reserve (FFR) has been increasingly used in the clinical workflow to assist clinical decision-making for percutaneous coronary intervention (PCI). This clinical study evaluates the diagnostic accuracy of coronary stenosis assessed by a non-invasive FFR analysis method (termed AccuFFRangio) based on invasive coronary angiography (ICA). It is a blinded, self-controlled, retrospective, and dual-center clinical investigation study.
Methods: Coronary angiography data and the related information of 320 patients with 320 vessels were collected, and AccuFFRangio was used to assess the FFR for these patients. Compared with the wire-measured FFR values, we evaluated AccuFFRangio performance by its accuracy, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV).
Results: The diagnostic accuracy, sensitivity, specificity, PPV, and NPV for AccuFFRangio in identifying hemodynamically significant coronary stenosis were 93.3%, 92.6%, 93.5%, 84.3%, and 97.1%, respectively. The direct correlation between computed AccuFFRangio and measured FFR was 0.812 (P<0.001), and the area under the receiver operating characteristic curve (AUC) value of AccuFFRangio was 0.96.
Conclusions: This clinical study demonstrates the efficiency and accuracy of AccuFFRangio for clinical implementation when using invasive wire-measured FFR as a reference. Further validation is required in a large prospective multicenter study.
Competing Interests: Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://dx.doi.org/10.21037/qims-21-463). JJ receives research grants from National Natural Science Foundation of China (81570322) and Zhejiang Provincial Key Research and Development Plan (2020C03016). LT receives research grant from Zhejiang Provincial Key Research and Development Plan (2017C03034). CD receives research grant from Major Medical and Health Science and Technology Plan of Zhejiang Province (WKJ-ZJ-1913). XL receives research grant from National Natural Science Foundation of China (11802113). CL reeives research grants from Zhejiang Provincial Public Welfare Technology Research Project (LGF20H020012) and Scientific Research Project of Zhejiang Education Department (Y201330290). JX receives research grant from National Natural Science Foundation of China (81771242) and Stock/Stock Options of ArteryFlow Technology.
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