HeartFlow's non-invasive AI driven FFR_CT predicts patient outcomes as effectively as the gold-standard invasive FFR out to 10 years

MOUNTAIN VIEW, Calif., March 12, 2024 (GLOBE NEWSWIRE) -- HeartFlow, Inc., a leader in non-invasive artificial intelligence (AI) heart care solutions, today announced that 10-year follow-up data from its DISCOVER-FLOW study were published in the Journal of Cardiovascular Computed Tomography.

At 10 years, HeartFlow’s FFR_CT Analysis, a non-invasive test for coronary artery disease (CAD), showed strong long-term risk stratification and displayed the risk continuum as effectively as invasive fractional flow reserve (FFR).¹ DISCOVER-FLOW was the first trial evaluating the HeartFlow FFR_CT Analysis and the new analysis aimed to determine the long-term prognostic implications of lesion-specific FFR_CT in patients with suspected or known CAD.

Key Takeaways from the study:

• FFR_CT was as predictive of patient outcomes through 10 years as invasive FFR
• Lesions with lower FFR_CT values were associated with ever-higher rates of cardiovascular death, heart attack, or a need for revascularization (stenting or bypass surgery) over the 10-year period
• FFR_CT was superior to CCTA stenosis severity alone for diagnosis of lesion-specific flow impairment
• FFR_CT is a critical part of the CAD diagnostic toolkit, equivalent to invasive FFR

“It’s rare to have the opportunity to follow patients for 10 years in clinical trials and we are delighted to confirm the long-term prognostic value of FFR_CT through the DISCOVER-FLOW study,” said Campbell Rogers, MD, FACC, Chief Medical Officer, HeartFlow. “These data are a reflection of our commitment to providing comprehensive clinical evidence on the diagnostic accuracy, safety, efficacy, and utility of the HeartFlow Analysis.”

The data build on HeartFlow’s extensive body of clinical evidence supporting AI-powered non-invasive diagnostic testing for patients with CAD. The company has spent the last decade working with clinicians to improve CAD diagnosis, making significant progress validated by high quality clinical evidence. HeartFlow’s approach is centered around scientific rigor with peer-reviewed publications to provide confidence and certainty to clinicians and the patients they serve. HeartFlow is committed to elevating the standard for AI technologies entering the healthcare space.

HeartFlow is the first company to offer a suite of technologies to help clinicians non-invasively identify and quantify narrowings in the coronary arteries (RoadMap™Analysis), assess the impact of each specific narrowing on coronary blood flow (FFR_CT Analysis), and characterize and quantify coronary atherosclerosis (Plaque Analysis). Together, this comprehensive solution offers valuable data not currently available with other non-invasive diagnostic tools or CTA-based AI analyses.

HeartFlow remains dedicated to reshaping cardiovascular care and was recently selected as a winner of the Fierce MedTech’s Fierce 15 award for moving the CAD diagnostics field forward with AI-powered analyses. The Fierce 15 spotlights the visionaries and trailblazers who have pioneered groundbreaking therapies, overhauled patient care models, and spearheaded innovative approaches to address the most pressing challenges in healthcare.

About HeartFlow, Inc.
HeartFlow is transforming precision coronary care with the only AI-powered non-invasive integrated heart care solution across the CCTA pathway. As the pioneer of FFR_CT, which is now supported by the ACC/AHA Chest Pain Guidelines, HeartFlow continues to advance the diagnosis and management of CAD. HeartFlow’s suite of non-invasive technologies includes its FFR_CT Analysis, RoadMap™Analysis, and Plaque Analysis. To date, more than 500 peer-reviewed publications have validated our approach and, more importantly, our technologies have helped clinicians diagnose and manage over 250,000 patients. For more information, visit www.heartflow.com and connect on Twitter and LinkedIn.

About DISCOVER-FLOW
DISCOVER-FLOW (Diagnosis of Ischemia-Causing Stenoses Obtained Via Noninvasive Fractional FLOW Reserve), an international, multicenter, prospective study, followed 156 vessels in 102 adults aged 18 and up with suspected or known CAD who underwent CCTA, FFRCT, ICA, and invasive FFR. Vessels were examined to determine the correlation between Target Vessel Failure (TVF) and FFR_CT / invasive FFR. The study compared the diagnostic performance of FFR_CT with CCTA stenosis for the diagnosis of lesion-specific ischemia, as determined by FFR performed at the time of ICA. DISCOVER-FLOW was conducted at four sites in three countries, Korea, Latvia, and the U.S. and was funded by HeartFlow, Inc. (Mountain View, California).

1 Yang, et al. Long-term prognostic implications of CT angiography-derived fractional flow reserve: Results from the DISCOVER-FLOW study. JCCT 2024. DOI: 10.1016/j.jcct.2024.01.016

Media contact
Linly Ku
lku@heartflow.com