Log in to MyACC
FAST-FFR Trial: Accuracy of FFR Derived From Coronary Angiography
Study Questions:
What is the accuracy of fractional flow reserve (FFR) derived from routine coronary angiography (FFRangio)?
Methods:
The investigators conducted a prospective, multicenter, international trial, the FAST-FFR (FFRangio Accuracy versus Standard FFR) study with the primary goal of determining the accuracy of FFRangio. 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 prespecified performance goals for sensitivity and specificity. A logistic mixed effects model accounted for multiple lesions per patient in the primary analysis. Pearson’s correlation coefficient between FFR and FFRangio was reported among vessels with FFR and FFRangio values above 0.50.
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% confidence interval [CI], 88-97%) and 91% (95% CI, 86-95%), respectively, both of which exceeded the prespecified 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:
The authors concluded that FFRangio measured from the coronary angiogram alone has a high sensitivity, specificity, and accuracy compared with pressure wire-derived FFR.
Perspective:
This study reports that FFR derived from routine coronary angiography (FFRangio) has very high sensitivity, specificity, and diagnostic accuracy, all of which are >90% for predicting the reference standard, coronary pressure wire-derived FFR. Furthermore, FFRangio and FFR remained highly correlated over the entire range of FFR values, and FFRangio was successfully measured in almost all cases included. Additional studies comparing FFRangio-guided revascularization strategy and either angiography-guided revascularization or an FFR-guided revascularization strategy are indicated to validate these results and this technique. If confirmed in future studies, FFRangio may eventually replace wire-based FFR measurement and substantially increase physiologic coronary lesion assessment in the catheterization laboratory, potentially leading to improved patient outcomes.
Keywords: TCT18, Transcatheter Cardiovascular Therapeutics, Angiography, Coronary Angiography, Coronary Artery Disease, Coronary Stenosis, Hemodynamics, Fractional Flow Reserve, Myocardial, Myocardial Ischemia, Myocardial Revascularization, Secondary Prevention
< Back to Listings
