Heartflow FFRCT Analysis Cuts Unnecessary Invasive Heart Procedures by 44% in Government-Funded FUSION Trial
核心洞察
The independent, government-funded FUSION trial showed adding Heartflow FFRCT Analysis (搜索) to standard CCTA reduced unnecessary invasive coronary angiography by 44% at one year (p < 0.001).
Overall invasive catheterization rates fell significantly in the Heartflow pathway (43% vs. 61%; p < 0.001), while coronary revascularization rates remained identical across groups (20% vs. 20%).
No significant differences emerged in safety endpoints, including major adverse cardiac events, ICA complications, or stroke, confirming the approach safely avoids unnecessary procedures.
Late-breaking one-year results from the independent, government-funded FUSION trial demonstrate that adding Heartflow FFRCT Analysis (搜索) to standard coronary computed tomography angiography (CCTA) safely and significantly reduced unnecessary invasive heart procedures by 44% (p < 0.001). 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 (JACC).
The FUSION trial, funded by the Dutch National Health Care Institute (搜索) through the Zorginstituut Nederland 'Potentially Promising Care' program, enrolled 528 patients with stable chest pain across twelve hospitals in the Netherlands. The study evaluated Heartflow FFRCT Analysis (搜索) across diverse scanner vendors in both academic and community hospital settings, with blinded, independent clinical event adjudication.
CCTA is the primary first-line test recommended by both European (ESC) and U.S. (ACC/AHA) guidelines for evaluating patients with suspected coronary artery disease (搜索) (CAD). However, visual assessment of CCTAs is limited to assessing anatomy and whether plaque is present; it cannot determine lesion-specific physiology or whether a blockage significantly restricts blood flow to the heart. This diagnostic uncertainty frequently leads physicians to refer patients for invasive coronary angiography (ICA), a hospital procedure where a catheter is threaded through an artery, normally in the groin or arm, to reach the heart and assess blocked or narrowed blood vessels.
Heartflow FFRCT bridges this diagnostic gap by applying advanced AI and computational fluid dynamics to standard CT scans with documented narrowings, creating a personalized 3D model that quantifies blood flow within the coronary arteries.
One-Year FUSION Results
The key one-year findings demonstrated a sustained 44% relative reduction in unnecessary ICA in the Heartflow pathway compared to the CCTA-only group (22% [57/263] Heartflow vs. 39% [103/265] CCTA alone; p < 0.001), consistent with the 90-day primary endpoint results (18% [48/263] vs. 33% [87/265] CCTA alone; p < 0.001).
Overall rates of ICA were significantly lower at one year in the Heartflow pathway compared to the CCTA-only group (43% [114/263] Heartflow vs. 61% [161/265] CCTA alone; p < 0.001). Critically, rates of coronary revascularization remained identical across groups (20% [52/263] vs. 20% [53/265]; p = 0.948), proving that safely reducing diagnostic catheter lab procedures did not prevent patients from receiving necessary intervention.
There were no significant differences in safety endpoints between pathways, including major adverse cardiac events (MACE), ICA complications, or stroke.
Validating Heartflow FFRCT at Critical Decision Points
While previous randomized controlled trials, such as FORECAST and PRECISE, evaluated the pathway of CCTA and Heartflow FFRCT in broader patient populations early in the diagnostic pathway, FUSION is the first randomized trial to test Heartflow FFRCT Analysis (搜索) at a pivotal clinical junction: immediately following a CCTA scan that identifies anatomically obstructive stenosis. This decision point was recently affirmed in the 2026 SCCT/SCAI expert consensus statement and endorsed by the ACC.
As an independent, government-funded study with no industry involvement in trial design or analysis, FUSION delivers robust, unbiased evidence supporting the routine integration of Heartflow FFRCT Analysis (搜索) into everyday clinical practice. The landmark findings build on more than 15 years of rigorous clinical research across major trials, further establishing Heartflow FFRCT as the leading and most extensively validated CT-FFR technology in cardiology.
"CCTA is established as the optimal first-line diagnostic test for coronary artery disease (搜索) 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, M.D., principal investigator of the FUSION trial and associate professor of cardiology at Erasmus MC in Rotterdam, Netherlands. "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."
"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, M.D., F.A.C.C., Chief Medical Officer at Heartflow. "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."
Technology and Clinical Footprint
Heartflow's technology applies clinically-proven AI and the world's largest coronary imaging dataset to redefine precision diagnostic testing and management for CAD. The platform has been adopted by more than 1,800 institutions globally and has redefined how clinicians manage care for over 750,000 patients worldwide. It is backed by American College of Cardiology and American Heart Association (ACC/AHA) guidelines and supported by more than 625 peer-reviewed publications.
The proprietary data pipeline is built from the world's largest database of more than 200 million annotated CTA images, powering advanced AI models that deliver highly accurate, reproducible diagnostic insights across diverse patient populations. Heartflow's AI-driven solutions have been validated through clinical evidence in over 200 studies assessing over 365,000 patients, and the platform is the only AI technology prospectively validated against invasive gold standards. Heartflow's coronary CTA image acceptance rates exceed 97%.