HeartFlow has presented results of computed fractional flow reserve (FFRCT) from Determination of Fractional Flow Reserve by Anatomic Computed Tomographic Angiography (DeFACTO) study.
DeFACTO study has enrolled 252 stable patients with suspected coronary artery disease to compare FFRCT with coronary CT angiography.
The study assessed the ability of FFRCT to identify flow-restricting lesions versus CT alone, by comparing the results to invasive fractional flow reserve (FFR).
The results demonstrated 20% improvement in the ability to identify flow-restricting arterial blockages over the use of CT alone using an area under the curve (AUC or Receiver Operating Characteristics) analysis (AUC 0.81 vs. 0.68, p=0.0002).
HeartFlow chairman and CEO John Stevens said the FFRCT technology holds the potential to substantially improve the ability of physicians to determine which patients need and do not need coronary angiography and intervention, resulting in better patient outcomes and reduced costs.
Cedars-Sinai Medical Center medicine, imaging and biomedical sciences department cardiac imaging research director and study principal investigator James Min said the results of the DeFACTO trial clearly demonstrate that when added to coronary CT angiographic findings, FFRCT provides essential physiologic information as to which specific arterial blockages truly restrict blood flow to the heart and heighten patient risk.
"Further, our findings suggest that FFRCT could be particularly useful for evaluating patients with arterial blockages of an intermediate severity, which often are the most difficult to assess non-invasively," Min added.