Diagnostic accuracy of CCTA-derived versus angiography-derived quantitative flow ratio (CAREER) study: a prospective study protocol

Tingwen Weng, Qian Gan, Zehang Li, Shaofeng Guan, Wenzheng Han, Xinrong Zhai, Ming Li, Lin Qi, Cheng Li, Yang Chen, Liang Zhang, Xifeng Chang, Shengxian Tu, Xinkai Qu, Tingwen Weng, Qian Gan, Zehang Li, Shaofeng Guan, Wenzheng Han, Xinrong Zhai, Ming Li, Lin Qi, Cheng Li, Yang Chen, Liang Zhang, Xifeng Chang, Shengxian Tu, Xinkai Qu

Abstract

Introduction: Coronary CT angiography (CCTA)-derived quantitative flow ratio (CT-QFR) is a novel non-invasive technology to assess the physiological significance of coronary stenoses, which enables fast and on-site computation of fractional flow reserve (FFR) from CCTA images. The objective of this investigator-initiated, prospective, single-centre clinical trial is to evaluate the diagnostic performance of CT-QFR with respect to angiography-derived QFR, using FFR as the reference standard.

Methods and analysis: A total of 216 patients who have at least one lesion with a diameter stenosis of 30%-90% in an artery with ≥2.0 mm reference diameter will be enrolled in the study. FFR will be measured during invasive coronary angiography. CT-QFR and QFR will be assessed in two independent core laboratories in a blinded fashion. The primary endpoint is the diagnostic accuracy of CT-QFR in identifying haemodynamically significant coronary stenosis with FFR as the reference standard. The major secondary endpoint is the non-inferiority of CT-QFR compared with QFR in the patients without extensively calcified lesions.

Ethics and dissemination: The study was approved by the Ethics Committee of Huadong Hospital Affiliated to Fudan University (2020K192). Outcomes will be disseminated through publications in peer-reviewed journals and presentations at scientific conferences.

Trial registration number: NCT04665817.

Keywords: adult cardiology; cardiomyopathy; coronary heart disease; coronary intervention; ischaemic heart disease.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Study flowchart. CCTA, coronary CT angiography; CT-QFR, CCTA-derived QFR; FFR, fractional flow reserve; QFR, quantitative flow ratio.

References

    1. Miller JM, Rochitte CE, Dewey M, et al. . Diagnostic performance of coronary angiography by 64-row CT. N Engl J Med 2008;359:2324–36. 10.1056/NEJMoa0806576
    1. Shaw LJ, Berman DS, Maron DJ, et al. . Optimal medical therapy with or without percutaneous coronary intervention to reduce ischemic burden: results from the clinical outcomes utilizing revascularization and aggressive drug evaluation (courage) trial nuclear substudy. Circulation 2008;117:1283–91. 10.1161/CIRCULATIONAHA.107.743963
    1. Kern MJ, Samady H. Current concepts of integrated coronary physiology in the catheterization laboratory. J Am Coll Cardiol 2010;55:173–85. 10.1016/j.jacc.2009.06.062
    1. Tonino PAL, Fearon WF, De Bruyne B, et al. . Angiographic versus functional severity of coronary artery stenoses in the fame study fractional flow reserve versus angiography in multivessel evaluation. J Am Coll Cardiol 2010;55:2816–21. 10.1016/j.jacc.2009.11.096
    1. Tonino PAL, De Bruyne B, Pijls NHJ, et al. . Fractional flow reserve versus angiography for guiding percutaneous coronary intervention. N Engl J Med 2009;360:213–24. 10.1056/NEJMoa0807611
    1. De Bruyne B, Pijls NH, Bartunek J, et al. . Fractional flow reserve in patients with prior myocardial infarction. Circulation 2001;104:157–62. 10.1161/01.CIR.104.2.157
    1. Xaplanteris P, Fournier S, Pijls NHJ, et al. . Five-year outcomes with PCI guided by fractional flow reserve. N Engl J Med 2018;379:250–9. 10.1056/NEJMoa1803538
    1. Neumann FJ, Sousa-Uva M, Ahlsson A. ESC/EACTS guidelines on myocardial revascularization. The task force on myocardial revascularization of the European society of cardiology (ESC) and European association for cardio-thoracic surgery (EACTS)][J]. G Ital Cardiol 2018;2019:1S–61.
    1. Tu S, Westra J, Yang J, et al. . Diagnostic accuracy of fast computational approaches to derive fractional flow reserve from diagnostic coronary angiography: the international multicenter FAVOR pilot study. JACC Cardiovasc Interv 2016;9:2024–35. 10.1016/j.jcin.2016.07.013
    1. Westra J, Tu S, Campo G, et al. . Diagnostic performance of quantitative flow ratio in prospectively enrolled patients: an individual patient-data meta-analysis. Catheter Cardiovasc Interv 2019;94:693–701. 10.1002/ccd.28283
    1. Li Z, Zhang J, Xu L, et al. . Diagnostic accuracy of a fast computational approach to derive fractional flow reserve from coronary CT angiography. JACC Cardiovasc Imaging 2020;13:172–5. 10.1016/j.jcmg.2019.08.003
    1. Koo B-K, Erglis A, Doh J-H, et al. . Diagnosis of ischemia-causing coronary stenoses by noninvasive fractional flow reserve computed from coronary computed tomographic angiograms. results from the prospective multicenter DISCOVER-FLOW (diagnosis of Ischemia-causing stenoses obtained via noninvasive fractional flow reserve) study. J Am Coll Cardiol 2011;58:1989–97. 10.1016/j.jacc.2011.06.066
    1. Wang Z-Q, Zhou Y-J, Zhao Y, et al. . Diagnostic accuracy of a deep learning approach to calculate FFR from coronary CT angiography. J Geriatr Cardiol 2019;16:42–8. 10.11909/j.issn.1671-5411.2019.01.010
    1. Min JK, Berman DS, Budoff MJ, et al. . Rationale and design of the DeFACTO (determination of fractional flow reserve by anatomic computed tomographic angiography) study. J Cardiovasc Comput Tomogr 2011;5:301–9. 10.1016/j.jcct.2011.08.003
    1. Xu B, Tu S, Qiao S, et al. . Diagnostic accuracy of angiography-based quantitative flow ratio measurements for online assessment of coronary stenosis. J Am Coll Cardiol 2017;70:3077–87. 10.1016/j.jacc.2017.10.035
    1. Leipsic J, Abbara S, Achenbach S, et al. . SCCT guidelines for the interpretation and reporting of coronary CT angiography: a report of the society of cardiovascular computed tomography guidelines committee. J Cardiovasc Comput Tomogr 2014;8:342–58. 10.1016/j.jcct.2014.07.003
    1. Tu S, Ding D, Chang Y. Diagnostic accuracy of quantitative flow ratio for assessment of coronary stenosis significance from a single angiographic view: a novel method based on bifurcation fractal law[J]. Catheter Cardiovasc Interv 2021. 10.1002/ccd.29592
    1. Taylor CA, Fonte TA, Min JK. Computational fluid dynamics applied to cardiac computed tomography for noninvasive quantification of fractional flow reserve: scientific basis. J Am Coll Cardiol 2013;61:2233–41. 10.1016/j.jacc.2012.11.083
    1. Nakazato R, Park H-B, Berman DS, et al. . Noninvasive fractional flow reserve derived from computed tomography angiography for coronary lesions of intermediate stenosis severity: results from the DeFACTO study. Circ Cardiovasc Imaging 2013;6:881–9. 10.1161/CIRCIMAGING.113.000297
    1. Nørgaard BL, Leipsic J, Gaur S, et al. . Diagnostic performance of noninvasive fractional flow reserve derived from coronary computed tomography angiography in suspected coronary artery disease: the NXT trial (analysis of coronary blood flow using CT angiography: next steps). J Am Coll Cardiol 2014;63:1145–55. 10.1016/j.jacc.2013.11.043
    1. Douglas PS, Pontone G, Hlatky MA, et al. . Clinical outcomes of fractional flow reserve by computed tomographic angiography-guided diagnostic strategies vs. usual care in patients with suspected coronary artery disease: the prospective longitudinal trial of FFR(CT): outcome and resource impacts study. Eur Heart J 2015;36:3359–67. 10.1093/eurheartj/ehv444
    1. Lu MT, Ferencik M, Roberts RS, et al. . Noninvasive FFR derived from coronary CT angiography: management and outcomes in the PROMISE trial. JACC Cardiovasc Imaging 2017;10:1350–8. 10.1016/j.jcmg.2016.11.024
    1. Nørgaard BL, Leipsic J, Koo B-K, et al. . Coronary computed tomography angiography derived fractional flow reserve and plaque stress. Curr Cardiovasc Imaging Rep 2016;9:2. 10.1007/s12410-015-9366-5
    1. Westra J, Andersen BK, Campo G, et al. . Diagnostic performance of in-procedure angiography-derived quantitative flow reserve compared to pressure-derived fractional flow reserve: the favor II Europe-Japan study. J Am Heart Assoc 2018;7. 10.1161/JAHA.118.009603. [Epub ahead of print: 06 07 2018].
    1. Westra J, Tu S, Winther S. Evaluation of coronary artery stenosis by quantitative flow ratio during invasive coronary angiography: the WIFI II study (Wire-Free Functional Imaging II)[J]. Circ Cardiovasc Imaging 2018;11:e7107. 10.1161/CIRCIMAGING.117.007107
    1. Hlatky MA, De Bruyne B, Pontone G, et al. . Quality-of-life and economic outcomes of assessing fractional flow reserve with computed tomography angiography: platform. J Am Coll Cardiol 2015;66:2315–23. 10.1016/j.jacc.2015.09.051
    1. Patel MR, Nørgaard BL, Fairbairn TA, et al. . 1-Year Impact on medical practice and clinical outcomes of FFRCT: the advance registry. JACC Cardiovasc Imaging 2020;13:97–105. 10.1016/j.jcmg.2019.03.003

Source: PubMed

Sponsorit ja yhteistyökumppanit

Sairaudet

Huumeiden interventiot

3
Tilaa