DeFACTO Propels CT Fractional Flow Reserve Closer to Clinical Practice

High sensitivity/low specificity among patients with intermediate stenoses suggests "a low false-negative rate if assessments by FFR-CT were used to identify ischemia causing intermediate lesions, with negligible effects on reductions of false positive results. In this regard, the use of FFR-CT may significantly advance clinical assessment of patients without conventional measures of anatomic high-grade coronary stenosis, largely by proper identification of a significantly greater proportion of patients with manifest ischemia rather than as a safeguard to further invasive evaluation," the researchers noted.

They also pointed out that the prespecified primary end point for FFR-CT – a lower bound of the 95% confidence interval greater than 70% – "represents a 15% increase over traditional noninvasive histologic imaging methods, including myocardial perfusion imaging by SPECT or stress echocardiography," Dr. Min said.

Dr. Min and several of his coauthors reported significant financial relationships with GE Healthcare and Philips Medical, as well as other medical imaging/pharmaceutical companies. Dr. Jason H. Cole reported a grant for research support from HeartFlow. Dr. John Mancini reported a grant to his institution from HeartFlow. This study was funded by HeartFlow.