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 |
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| Hauptverfasser: | , , , , , , , , , , , , , , , , , |
| Format: | Journal Article |
| Sprache: | Englisch |
| Veröffentlicht: |
United States
22.01.2019
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| ISSN: | 1524-4539, 1524-4539 |
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| Abstract | 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. |
|---|---|
| AbstractList | 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 (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.BACKGROUNDMeasuring 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 (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.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 FFRangio using proprietary software. Coprimary end points 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.METHODSCoronary 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 FFRangio using proprietary software. Coprimary end points 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.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 FFRangio was 92% overall and remained high when only considering FFR values between 0.75 to 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%.RESULTSTen 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 FFRangio was 92% overall and remained high when only considering FFR values between 0.75 to 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%.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 physiological coronary lesion assessment in the catheterization laboratory, thereby potentially leading to improved patient outcomes.CONCLUSIONSFFRangio 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 physiological coronary lesion assessment in the catheterization laboratory, thereby potentially leading to improved patient outcomes.URL: https://www.clinicaltrials.gov . Unique Identifier: NCT03226262.CLINICAL TRIAL REGISTRATIONURL: https://www.clinicaltrials.gov . Unique Identifier: NCT03226262. 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. |
| Author | Fearon, William F Kirtane, Ajay J Dressler, Ovidiu Jubeh, Rami Matsumura, Mitsuaki Fournier, Stephane McAndrew, Thomas Assali, Abid Shlofmitz, Richard Engstrom, Thomas De Bruyne, Bernard Kolansky, Daniel M Maehara, Akiko Achenbach, Stephan Greenberg, Gabriel Leon, Martin B Kornowski, Ran Jeremias, Allen |
| Author_xml | – sequence: 1 givenname: William F surname: Fearon fullname: Fearon, William F organization: Division of Cardiovascular Medicine and Stanford Cardiovascular Institute, Stanford University School of Medicine, CA (W.F.F.) – sequence: 2 givenname: Stephan surname: Achenbach fullname: Achenbach, Stephan organization: Department of Cardiology, Friedrich-Alexander University Erlangen-Nürnberg, Germany (S.A.) – sequence: 3 givenname: Thomas surname: Engstrom fullname: Engstrom, Thomas organization: The Heart Center, Rigs Hospital, University of Copenhagen, Denmark (T.E.) – sequence: 4 givenname: Abid surname: Assali fullname: Assali, Abid organization: Department of Cardiology, Rabin Medical Center, Petach Tikva, Israel (A.A., R.K.) – sequence: 5 givenname: Richard surname: Shlofmitz fullname: Shlofmitz, Richard organization: Department of Cardiology, St. Francis Hospital, Roslyn, NY (R.S., A.J.) – sequence: 6 givenname: Allen surname: Jeremias fullname: Jeremias, Allen organization: Department of Cardiology, St. Francis Hospital, Roslyn, NY (R.S., A.J.) – sequence: 7 givenname: Stephane surname: Fournier fullname: Fournier, Stephane organization: Department of Cardiology, Cardiovascular Center Aalst OLV Hospital, Belgium (S.F., B.D.B.) – sequence: 8 givenname: Ajay J surname: Kirtane fullname: Kirtane, Ajay J organization: Cardiovascular Research Foundation (A.J.K., A.M., M.B.L., T.M., O.D., M.M.), New York, NY – sequence: 9 givenname: Ran surname: Kornowski fullname: Kornowski, Ran organization: Department of Cardiology, Rabin Medical Center, Petach Tikva, Israel (A.A., R.K.) – sequence: 10 givenname: Gabriel surname: Greenberg fullname: Greenberg, Gabriel organization: Department of Cardiology, HaSharon Medical Center, Petach Tikva, Israel (G.G.) – sequence: 11 givenname: Rami surname: Jubeh fullname: Jubeh, Rami organization: Department of Cardiology, Shaare Zedek Medical Center, Jerusalem, Israel (R.J.) – sequence: 12 givenname: Daniel M surname: Kolansky fullname: Kolansky, Daniel M organization: Division of Cardiovascular Medicine, University of Pennsylvania School of Medicine, Philadelphia (D.M.K.) – sequence: 13 givenname: Thomas surname: McAndrew fullname: McAndrew, Thomas organization: Cardiovascular Research Foundation (A.J.K., A.M., M.B.L., T.M., O.D., M.M.), New York, NY – sequence: 14 givenname: Ovidiu surname: Dressler fullname: Dressler, Ovidiu organization: Cardiovascular Research Foundation (A.J.K., A.M., M.B.L., T.M., O.D., M.M.), New York, NY – sequence: 15 givenname: Akiko surname: Maehara fullname: Maehara, Akiko organization: Cardiovascular Research Foundation (A.J.K., A.M., M.B.L., T.M., O.D., M.M.), New York, NY – sequence: 16 givenname: Mitsuaki surname: Matsumura fullname: Matsumura, Mitsuaki organization: Cardiovascular Research Foundation (A.J.K., A.M., M.B.L., T.M., O.D., M.M.), New York, NY – sequence: 17 givenname: Martin B surname: Leon fullname: Leon, Martin B organization: Cardiovascular Research Foundation (A.J.K., A.M., M.B.L., T.M., O.D., M.M.), New York, NY – sequence: 18 givenname: Bernard surname: De Bruyne fullname: De Bruyne, Bernard organization: Department of Cardiology, Cardiovascular Center Aalst OLV Hospital, Belgium (S.F., B.D.B.) |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/30586699$$D View this record in MEDLINE/PubMed |
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| Keywords | coronary artery disease coronary circulation fractional flow reserve, myocardial |
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| PublicationDate_xml | – month: 01 year: 2019 text: 2019-01-22 day: 22 |
| PublicationDecade | 2010 |
| PublicationPlace | United States |
| PublicationPlace_xml | – name: United States |
| PublicationTitle | Circulation (New York, N.Y.) |
| PublicationTitleAlternate | Circulation |
| PublicationYear | 2019 |
| References | 30586782 - Circulation. 2019 Jan 22;139(4):485-488. doi: 10.1161/CIRCULATIONAHA.118.037528. 31283375 - Circulation. 2019 Jul 9;140(2):e94-e95. doi: 10.1161/CIRCULATIONAHA.118.038282. 31283372 - Circulation. 2019 Jul 9;140(2):e96-e97. doi: 10.1161/CIRCULATIONAHA.119.040942. |
| References_xml | – reference: 31283375 - Circulation. 2019 Jul 9;140(2):e94-e95. doi: 10.1161/CIRCULATIONAHA.118.038282. – reference: 30586782 - Circulation. 2019 Jan 22;139(4):485-488. doi: 10.1161/CIRCULATIONAHA.118.037528. – reference: 31283372 - Circulation. 2019 Jul 9;140(2):e96-e97. doi: 10.1161/CIRCULATIONAHA.119.040942. |
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| Snippet | Measuring fractional flow reserve (FFR) with a pressure wire remains underutilized because of the invasiveness of guide wire placement or the need for a... |
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| SubjectTerms | 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 |
| Title | Accuracy of Fractional Flow Reserve Derived From Coronary Angiography |
| URI | https://www.ncbi.nlm.nih.gov/pubmed/30586699 https://www.proquest.com/docview/2161065691 |
| Volume | 139 |
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