A 2024 study published in European Radiology that validates a novel stepwise strategy integrating CCTA, Deep Learning FFRCT, and CT-MPI to improve diagnostic accuracy for stable CAD.

Lyu, L., Pan, J., Li, D. et al. A stepwise strategy integrating dynamic stress CT myocardial perfusion and deep learning–based FFRCT in the work-up of stable coronary artery disease. Eur Radiol (2024).

Introduction:

Accurate diagnostic tests are essential for identifying patients who need revascularization. Fractional flow reserve (FFR) is the gold standard for this, but its invasive nature and high costs limit its use [1, 2, 3, 4]. Noninvasive alternatives, such as coronary computed tomography angiography (CCTA), have high negative predictive value but cannot assess the physiological significance of coronary artery stenosis [5–11]. To overcome this, computed tomography–derived fractional flow reserve (FFRCT) and computed tomography myocardial perfusion imaging (CT-MPI) have been developed. Despite their potential, handling FFRCT gray zone values (around 0.80) remains challenging [12–25]. This blog post discusses a recent study from European Radiology (2024) that validates a novel stepwise strategy integrating CCTA, FFRCT, and CT-MPI to improve diagnostic accuracy for stable CAD.

Key Insights:

  • Stepwise CCTA + FFRCT + CT-MPI Strategy: This approach holds promise as a viable method to reduce the need for invasive diagnostic catheterization while maintaining high agreement with ICA/FFR.
  • Superior Performance: The strategy performed better than both CCTA + FFRCT and CCTA + CT-MPI strategies.
  • Reduced Invasiveness: It minimizes unnecessary invasive diagnostic catheterization and helps clinicians make more confident decisions about referral or deferral for ICA/FFR.

Clinical Impact:

This novel stepwise strategy facilitates greater confidence and accuracy when clinicians decide on interventional coronary angiography (ICA) referral or deferral, reducing the burden of invasive investigations on patients.

ABSTRACT

Objective:

To validate a stepwise strategy using FFRCT for intermediate stenosis on CCTA and CT-MPI for vessels with gray zone FFRCT values.

Materials and Methods:

This retrospective, single-center, prognostic study included 87 patients (58 ± 10 years; 70% male) who underwent CCTA, dynamic CT-MPI, interventional coronary angiography (ICA), and FFR. FFRCT were calculated using commercially available machine learning-based FFRct software (DEEPVESSEL FFR, Keya Medical). The diagnostic performance of three strategies (CCTA + FFRCT + CT-MPI, CCTA + FFRCT, and CCTA + CT-MPI) was evaluated using ICA/FFR as the reference. The net reclassification index (NRI) was calculated to compare models.

Details of the FFRCT algorithm are provided in the Supplemental Methods.

Results:

The CCTA + FFRCT + CT-MPI strategy resulted in the lowest proportion of vessels needing additional ICA/FFR measurement compared to the CCTA + FFRCT and CCTA + CT-MPI strategies (12%, 22%, and 24% respectively). It exhibited the highest accuracy for ruling out (91%, 84%, and 85%) and ruling in (90%, 85%, and 85%) functionally significant lesions. All strategies had comparable sensitivity for ruling out and specificity for ruling in significant lesions (p > 0.05). The NRI indicated that the CCTA + FFRCT + CT-MPI strategy outperformed both the CCTA + FFRCT (NRI = 0.238, p < 0.001) and the CCTA + CT-MPI strategies (NRI = 0.233, p < 0.001).

Conclusion:

The CCTA + FFRCT + CT-MPI stepwise strategy was superior to the CCTA + FFRCT and CCTA + CT-MPI strategies by minimizing unnecessary invasive diagnostic catheterization without compromising agreement with ICA/FFR.

References:

  1. Pijls NH, De Bruyne B, Peels K et al. (1996). Measurement of fractional flow reserve to assess the functional severity of coronary-artery stenoses. N Engl J Med, 334:1703–1708.
  2. Xaplanteris P, Fournier S, Pijls NHJ et al. (2018). Five-year outcomes with PCI guided by fractional flow reserve. N Engl J Med, 379:250–259.
  3. Härle T, Zeymer U, Hochadel M et al. (2017). Real-world use of fractional flow reserve in Germany: results of the prospective ALKK coronary angiography and PCI registry. Clin Res Cardiol, 106:140–150.
  4. Desai NR, Bradley SM, Parzynski CS et al. (2015). Appropriate use criteria for coronary revascularization and trends in utilization, patient selection, and appropriateness of percutaneous coronary intervention. JAMA, 314:2045–2053.
  5. Knuuti J, Wijns W, Saraste A et al. (2020). 2019 ESC Guidelines for the diagnosis and management of chronic coronary syndromes. Eur Heart J, 41:407–477.
  6. National Institute for Health and Clinical Excellence (2016). Chest pain of recent onset: assessment and diagnosis of recent onset chest pain or discomfort of suspected cardiac origin (update). Clinical guideline 95.
  7. Gulati M, Levy PD, Mukherjee D et al. (2021). 2021 AHA/ACC/ASE/CHEST/SAEM/SCCT/SCMR Guideline for the evaluation and diagnosis of chest pain: executive summary: a report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation, 144:e368–e454.
  8. Budoff MJ, Dowe D, Jollis JG et al. (2008). Diagnostic performance of 64-multidetector row coronary computed tomographic angiography for evaluation of coronary artery stenosis in individuals without known coronary artery disease: results from the prospective multicenter ACCURACY (Assessment by Coronary Computed Tomographic Angiography of Individuals Undergoing Invasive Coronary Angiography) trial. J Am Coll Cardiol, 52:1724–1732.
  9. de Graaf FR, Schuijf JD, van Velzen JE et al. (2010). Diagnostic accuracy of 320-row multidetector computed tomography coronary angiography in the non-invasive evaluation of significant coronary artery disease. Eur Heart J, 31:1908–1915.
  10. Meijboom WB, Meijs MF, Schuijf JD et al. (2008). Diagnostic accuracy of 64-slice computed tomography coronary angiography: a prospective, multicenter, multivendor study. J Am Coll Cardiol, 52:2135–2144.
  11. Raff GL. (2007). Interpreting the evidence: how accurate is coronary computed tomography angiography? J Cardiovasc Comput Tomogr, 1:73–77.
  12. Tesche C, De Cecco CN, Baumann S et al. (2018). Coronary CT angiography-derived fractional flow reserve: machine learning algorithm versus computational fluid dynamics modeling. Radiology, 288:64–72.
  13. Coenen A, Kim Y-H, Kruk M et al. (2018). Diagnostic accuracy of a machine-learning approach to coronary computed tomographic angiography-based fractional flow reserve: result from the MACHINE Consortium. Circ Cardiovasc Imaging, 11:e007217.
  14. Nørgaard BL, Leipsic J, Gaur S et al. (2014). 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, 63:1145–1155.
  15. Nakazato R, Park H-B, Berman DS et al. (2013). Noninvasive fractional flow reserve derived from computed tomography angiography for coronary lesions of intermediate stenosis severity: results from the DeFACTO study. Circ Cardiovasc Imaging, 6:881–889.
  16. Koo BK, Erglis A, Doh JH et al. (2011). 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, 58:1989–1997.
  17. Patel MR, Nørgaard BL, Fairbairn TA et al. (2020). 1-year impact on medical practice and clinical outcomes of FFRCT: the ADVANCE Registry. JACC Cardiovasc Imaging, 13(1 Pt 1):97–105.
  18. Yang J, Shan D, Wang X et al. (2023). On-site computed tomography-derived fractional flow reserve to guide management of patients with stable coronary artery disease: the TARGET randomized trial. Circulation, 147:1369–1381.
  19. Kruk M, Wardziak Ł, Demkow M et al. (2016). Workstation-based calculation of CTA-based FFR for intermediate stenosis. JACC Cardiovasc Imaging, 9:690–699.
  20. Cook CM, Petraco R, Shun-Shin MJ et al. (2017). Diagnostic accuracy of computed tomography-derived fractional flow reserve: a systematic review. JAMA Cardiol, 2:803–810.
  21. Celeng C, Leiner T, Maurovich-Horvat P et al. (2019). Anatomical and functional computed tomography for diagnosing hemodynamically significant coronary artery disease: a meta-analysis. JACC Cardiovasc Imaging, 12:1316–1325.
  22. Coenen A, Rossi A, Lubbers MM et al (2017) Integrating CT myocardial
  23. perfusion and CT-FFR in the work-up of coronary artery disease. JACC
  24. Cardiovasc Imaging 10:760–770
  25. Hecht HS, Narula J, Fearon WF (2016) Fractional flow reserve and coronary
  26. computed tomographic angiography: a review and critical analysis. Circ
  27. Res 119:300–316
  28. Pontone G, Baggiano A, Andreini D et al (2019) Dynamic stress computed
  29. tomography perfusion with a whole-heart coverage scanner in addition to
  30. coronary computed tomography angiography and fractional flow reserve
  31. computed tomography derived. JACC Cardiovasc Imaging 12:2460–2471
  32. Yu M, Shen C, Dai X et al (2020) Clinical outcomes of dynamic computed
  33. tomography myocardial perfusion imaging combined with coronary
  34. computed tomography angiography versus coronary computed tomography
  35. angiography-guided strategy. Circ Cardiovasc Imaging 13:e009775

About DEEPVESSEL FFR

DEEPVESSEL FFR is a software medical device that uses deep learning technology to perform a non-invasive physiological functional assessment of the coronary arteries using coronary computed tomography angiography (CCTA). The software processes coronary CTA images semi-automatically, generates a three-dimensional model of the coronary artery tree, and estimates CT FFR values. DEEPVESSEL FFR is FDA-Cleared, CE-Marked, and NMPA-Cleared.

About Keya Medical

Keya Medical is an international medical technology company developing deep learning-based medical devices for disease diagnosis and treatment. The company is committed to creating solutions that deliver clinical value at all stages in the patient care process, covering specialties including cardiology, neurology, pulmonology, pathology, and surgery. Keya Medical has four centers of excellence in Beijing, Shanghai, Shenzhen, and Seattle. Follow us on LinkedIn, Twitter, and Facebook.

Media Contact
contact@keyamedna.com

Learn more about DEEPVESSEL FFR

We are actively looking for clinical partners in the United States and EMEA.