Rationale and design of the HeartFlowNXT (HeartFlow analysis of coronary blood flow using CT angiography: NeXt sTeps)

Sara Gaur1, Stephan Achenbach, Jonathon Leipsic

  • 1Department of Cardiology, Aarhus University Hospital, Brendstrupgaardsvej 100, 8200 Aarhus N, Skejby, Denmark.

Insights

Computed fractional flow reserve (FFRCT) from coronary CT angiography shows promise for identifying significant coronary artery disease. This study evaluates FFRCT

Area of Science:

  • Cardiovascular Imaging
  • Interventional Cardiology
  • Medical Device Technology

Background:

  • Coronary CT angiography (CTA) visualizes coronary artery disease but lacks physiological information to identify ischemia-causing lesions.
  • Computed fractional flow reserve (FFRCT) from CTA images offers a noninvasive method to assess lesion-specific ischemia.
  • The diagnostic performance of FFRCT compared to invasive fractional flow reserve (FFR) requires further establishment.

Purpose of the Study:

  • To evaluate the diagnostic performance of FFRCT for detecting and excluding flow-limiting coronary stenoses.
  • To compare the diagnostic accuracy of FFRCT against coronary CTA alone in identifying hemodynamically significant coronary lesions.
  • To establish FFRCT as a reliable noninvasive tool for assessing coronary artery disease.

Main Methods:

  • Prospective, international, multicenter study (HeartFlowNXT) involving 270 subjects.
  • Coronary CTA and invasive coronary angiography with FFR performed on all participants.
  • Blinded core laboratory interpretation for FFRCT, invasive angiography, and FFR measurements.

Main Results:

  • The study aims to determine the diagnostic performance of FFRCT versus coronary CTA alone.
  • Secondary endpoints include assessment of diagnostic accuracy, sensitivity, specificity, PPV, and NPV of FFRCT.
  • FFR values ≤ 0.80 will define ischemia-causing lesions.

Conclusions:

  • FFRCT holds potential for noninvasively assessing hemodynamically significant coronary lesions.
  • This research will clarify the role of FFRCT in the diagnosis of coronary artery disease.
  • Establishing FFRCT's diagnostic performance is crucial for its clinical integration.
Abstract