FFRCT Helps Cut Unnecessary Heart Angiograms by 44%

One-year results from the FUSION randomized controlled trial show that adding computed tomography (CT)-derived fractional flow reserve (FFRCT) to coronary CT angiography (CCTA) significantly reduced the rate of invasive coronary angiography (ICA) performed without evidence of obstructive coronary artery disease (CAD), without changing how many patients ultimately underwent revascularization.¹

“CCTA is established as the optimal first-line diagnostic test for coronary artery disease as it is noninvasive, but when anatomical scans show intermediate stenosis, determining whether that blockage is clinically significant remains a critical challenge,” said Alexander Hirsch, MD, principal investigator of the FUSION trial and associate professor of cardiology at Erasmus MC in Rotterdam, Netherlands, in a statement.² “The FUSION trial shows that adding Heartflow lesion-specific physiology makes CCTA even more powerful and improves diagnostic efficiency. It gives clinicians the clarity to know which patients require further invasive testing, safely avoiding unnecessary invasive catheterizations while maintaining excellent patient outcomes.”

The findings were presented as late-breaking science at the European Society of Cardiology (ESC) Congress 2026 and published simultaneously in the Journal of the American College of Cardiology.¹

Trial Addressed a Specific Diagnostic Gap

CCTA is a preferred first-line noninvasive test for many patients with suspected chronic coronary syndrome, particularly those with low-to-moderate clinical likelihood of obstructive CAD. However, anatomic stenosis on CCTA does not necessarily indicate hemodynamically significant disease. The 2024 ESC guidelines recommend functional imaging when CCTA shows CAD of uncertain functional significance.³ FFRCT uses computational modeling of CCTA images to estimate lesion-specific coronary blood flow and may help determine which patients require invasive evaluation.

FUSION enrolled 528 patients with a 50%-90% stenosis on CCTA across 12 Dutch hospitals and randomized them to FFRCT-guided care or usual care, with management decisions in both arms left to the treating physician.¹

ICA Without Obstructive Disease Fell at 90 Days and 1 Year

At 90 days, the primary end point, ICA without obstructive CAD, occurred in 18% of the FFRCT group vs 33% of the usual-care group (OR, 0.46; 95% CI, 0.31-0.69; P < .001). The effect persisted at 1 year, with rates of 22% vs 39%, respectively (OR, 0.44; 95% CI, 0.30-0.64; P < .001). Overall ICA use, a post hoc exploratory outcome, was also lower in the FFRCT group at both time points, falling from 61% to 43% at 1 year (OR, 0.49; 95% CI, 0.35-0.70; P < .001)

Revascularization rates at 1 year were nearly identical between groups (20% [52/263] vs 20% [53/265]; P = .948), indicating that fewer diagnostic catheterizations did not translate into missed treatment. Major adverse cardiac events, quality of life, and angina status also did not differ significantly, though the trial was not powered to detect differences in clinical events, which were infrequent overall. Adding FFRCT did not lower 1-year costs, however; the FFRCT group's mean CAD-related costs were numerically higher than usual care (€3842 vs €3415, based on a €1000 per-analysis price; approximately $4500 vs $4000, respectively, based on an assumed $1165 cost per FFRCT analysis), as savings from fewer angiograms did not fully offset the cost of the analysis itself.

However, the researchers acknowledged some limitations. The authors noted that the study was conducted in a predominantly White Dutch population and that treatment decisions, including how strictly FFRCT results were followed, were left to physician discretion, potentially limiting generalizability.

“One of the persistent challenges in cardiology has been accurately identifying, prior to catheterization, which patients have disease severe enough to warrant an invasive procedure,” said Campbell Rogers, MD, FACC, chief medical officer at Heartflow, in a statement.² “The FUSION data demonstrate that our technology can meaningfully address this challenge, providing physicians with more precise insight into a patient's disease burden after CCTA has documented stenosis over 50%. This allows care teams to direct invasive procedures to the patients most likely to benefit, while sparing others the risk and burden of a catheterization they may not require.”

References

1. Sharma SP, Budde RPJ, van der Zee PM, et al. Addition of computed tomography-derived fractional flow reserve in the diagnostic pathway of patients with stable coronary artery disease: the FUSION randomized controlled trial. J Am Coll Cardiol. Published online August 28, 2026. doi:10.1016/j.jacc.2026.08.036
2. Late-breaking data from independent government-funded trial at ESC shows Heartflow FFRCT analysis reduces unnecessary invasive heart procedures by nearly half. News release. Heartflow, Inc. August 28, 2026. Accessed August 28, 2026. https://www.globenewswire.com/news-release/2026/08/28/3352507/0/en/late-breaking-data-from-independent-government-funded-trial-at-esc-shows-heartflow-ffrct-analysis-reduces-unnecessary-invasive-heart-procedures-by-nearly-half.html
3. Vrints C, Andreotti F, Koskinas KC, et al. 2024 ESC guidelines for the management of chronic coronary syndromes. Eur Heart J. 2024;45(36):3415-3537. doi:10.1093/eurheartj/ehae177