Accuracy of Fractional Flow Reserve Derived From Coronary Angiography

Measuring fractional flow reserve (FFR) with a pressure wire remains underutilized because of the invasiveness of guide wire placement or the need for a hyperemic stimulus. FFR derived from routine coronary angiography (FFR ) eliminates both of these requirements and displays FFR values of the entir...

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Veröffentlicht in:Circulation (New York, N.Y.) Jg. 139; H. 4; S. 477
Hauptverfasser: Fearon, William F, Achenbach, Stephan, Engstrom, Thomas, Assali, Abid, Shlofmitz, Richard, Jeremias, Allen, Fournier, Stephane, Kirtane, Ajay J, Kornowski, Ran, Greenberg, Gabriel, Jubeh, Rami, Kolansky, Daniel M, McAndrew, Thomas, Dressler, Ovidiu, Maehara, Akiko, Matsumura, Mitsuaki, Leon, Martin B, De Bruyne, Bernard
Format: Journal Article
Sprache:Englisch
Veröffentlicht: United States 22.01.2019
Schlagworte:
Aged
Cardiac Catheterization
Coronary Angiography - methods
Coronary Artery Disease - diagnostic imaging
Coronary Artery Disease - physiopathology
Coronary Stenosis - diagnostic imaging
Coronary Stenosis - physiopathology
Coronary Vessels - diagnostic imaging
Coronary Vessels - physiopathology
Europe
Female
Fractional Flow Reserve, Myocardial
Humans
Imaging, Three-Dimensional - methods
Israel
Male
Middle Aged
Predictive Value of Tests
Prospective Studies
Radiographic Image Interpretation, Computer-Assisted - methods
Reproducibility of Results
Severity of Illness Index
United States
United States
Europe
Israel
coronary artery disease
coronary circulation
fractional flow reserve, myocardial
ISSN:1524-4539, 1524-4539
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Zusammenfassung:Measuring fractional flow reserve (FFR) with a pressure wire remains underutilized because of the invasiveness of guide wire placement or the need for a hyperemic stimulus. FFR derived from routine coronary angiography (FFR ) eliminates both of these requirements and displays FFR values of the entire coronary tree. The FFR Accuracy versus Standard FFR (FAST-FFR) study is a prospective, multicenter, international trial with the primary goal of determining the accuracy of FFR . 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 ≥2 different projections, on-site operators blinded to FFR then calculated FFR using proprietary software. Coprimary end points were the sensitivity and specificity of the dichotomously scored FFR 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. 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% to 97%) and 91% (86% to 95%), respectively, both of which exceeded the prespecified performance goals. The diagnostic accuracy of FFR was 92% overall and remained high when only considering FFR values between 0.75 to 0.85 (87%). FFR 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 FFR was 99%. FFR measured from the coronary angiogram alone has a high sensitivity, specificity, and accuracy compared with pressure wire-derived FFR. FFR has the promise to substantially increase physiological coronary lesion assessment in the catheterization laboratory, thereby potentially leading to improved patient outcomes. URL: https://www.clinicaltrials.gov . Unique Identifier: NCT03226262.
Bibliographie:ObjectType-Article-2
SourceType-Scholarly Journals-1
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ISSN:1524-4539
1524-4539
DOI:10.1161/CIRCULATIONAHA.118.037350