BACKGROUND: Measuring fractional flow reserve (FFR) with a pressure wire remains underutilized due to the invasiveness of guide wire placement and/or the need for a hyperemic stimulus. FFR derived from routine coronary angiography (FFRangio) eliminates both of these requirements and displays FFR values of the entire coronary tree. The FFRangio Accuracy versus Standard FFR (FAST-FFR) study is a prospective, multicenter, international trial with the primary goal of determining the accuracy of FFRangio.METHODS: Coronary angiography was performed in a routine fashion in patients with suspected coronary artery disease. FFR was measured in vessels with coronary lesions of varying severity using a coronary pressure wire and hyperemic stimulus. Based on angiograms of the respective arteries acquired in at least two different projections, on-site operators blinded to FFR then calculated FFRangio using proprietary software. Co-primary endpoints were the sensitivity and specificity of the dichotomously scored FFRangio for predicting pressure wire-derived FFR using a cutoff value of 0.80. The study was powered to meet pre-specified performance goals for sensitivity and specificity.RESULTS: Ten centers in the United States, Europe and Israel enrolled a total of 301 subjects and 319 vessels meeting inclusion/exclusion criteria which were included in the final analysis. The mean FFR was 0.81 and 43% of vessels had an FFR=0.80. The per-vessel sensitivity and specificity were 94% (95% CI 88-97%) and 91% (86-95%), respectively, both of which exceeded the pre-specified performance goals. The diagnostic accuracy of FFRangio was 92% overall and remained high when only considering FFR values between 0.75-0.85 (87%). FFRangio values correlated well with FFR measurements (r=0.80, p<0.001) and the Bland Altman 95% confidence limits were between -0.14 and 0.12. The device success rate for FFRangio was 99%.CONCLUSIONS: FFRangio measured from the coronary angiogram alone has a high sensitivity, specificity and accuracy compared with pressure-wire derived FFR. FFRangio has the promise to substantially increase physiologic coronary lesion assessment in the catheterization laboratory, thereby potentially leading to improved patient outcomes.CLINICAL TRIAL REGISTRATION: URL: https://clinicaltrials.gov Unique Identifier: NCT03226262.
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