Heartflow FFRCT cuts unnecessary heart catheterisations by 44%
Heartflow has reported one-year results from the FUSION trial showing its FFR CT Analysis reduced unnecessary invasive coronary angiography (ICA) by 44% compared with standard coronary computed tomography angiography (CCTA) alone, with the finding carrying high statistical significance (p < 0.001). The data were presented as late-breaking science at the European Society of Cardiology Congress 2026 and published simultaneously in the Journal of the American College of Cardiology.
The randomised controlled trial enrolled 528 patients with stable chest pain across twelve hospitals in the Netherlands and was funded by the Dutch government's Zorginstituut Nederland programme, with no industry involvement in trial design or analysis. That independence is commercially meaningful for Heartflow: independent government-funded evidence typically carries greater weight with payers and guideline committees than company-sponsored studies.
Trial findings
The headline result was a sustained 44% relative reduction in unnecessary ICA at twelve months in the Heartflow pathway versus the CCTA-only group (22% versus 39%; p < 0.001), consistent with the 90-day primary endpoint. Overall ICA rates were also lower in the Heartflow arm (43% versus 61%; p < 0.001). Critically, revascularisation rates were identical across both groups at 20%, demonstrating that fewer catheterisations did not translate into missed interventions. There were no significant differences in major adverse cardiac events, ICA complications, or stroke between pathways.
The results address a well-documented diagnostic gap in cardiology. CCTA, recommended as first-line by both ESC and ACC/AHA guidelines, can identify anatomical plaque and stenosis but cannot quantify whether a blockage restricts blood flow sufficiently to warrant invasive follow-up. That uncertainty has historically pushed clinicians toward precautionary catheterisation, a hospital procedure carrying procedural risk, resource cost, and patient burden. Heartflow's platform applies AI and computational fluid dynamics to standard CT images to generate a personalised 3D model of coronary blood flow, providing a physiology readout alongside the anatomical picture.
Alexander Hirsch, associate professor of cardiology at Erasmus MC in Rotterdam and principal investigator of FUSION, said the technology "gives clinicians the clarity to know which patients require further invasive testing, safely avoiding unnecessary invasive catheterisations while maintaining excellent patient outcomes."
Market and competitive context
The CT-derived fractional flow reserve (CT-FFR) segment is growing as health systems come under pressure to reduce procedural volumes without compromising outcomes. Heartflow cites more than 15 years of clinical evidence across trials including FORECAST, PRECISE, and the earlier DISCOVER-FLOW and NXT studies, and says its technology has been adopted by more than 1,800 institutions globally. The company positions its platform as the only CT-FFR product prospectively validated against an invasive gold standard, a claim that, if sustained under regulatory and guideline scrutiny, represents a meaningful barrier for later entrants.
FUSION is the first randomised trial to evaluate CT-FFR at the specific clinical decision point immediately following a CCTA showing obstructive stenosis, a pathway affirmed in a 2026 expert consensus statement from the Society of Cardiovascular Computed Tomography and the Society for Cardiovascular Angiography and Interventions. Guideline inclusion at that particular junction would expand the addressable patient population beyond earlier validated use cases.
For Heartflow, which listed on Nasdaq under the ticker HTFL, the ESC presentation and simultaneous journal publication represent a material evidence milestone ahead of what is likely to be an active reimbursement and formulary negotiation cycle in European markets. Investors will be watching whether the company can convert the FUSION data into expanded coverage decisions, particularly within NHS-adjacent and Dutch health insurance frameworks where the funder of the trial has direct influence on reimbursement policy.