HeartFlow’s FFRCT in CCTA-First Diagnostic Pathway for CAD Studied in FISH&CHIPS Trial

September 5, 2023—HeartFlow, Inc. recently announced the presentation of 2-year results from FISH&CHIPS, which is a real-world, multicenter, retrospective clinical study of the impact of implementing the company’s FFR_CT (fractional flow reserve coronary CT angiography [CCTA]) in a CCTA-first diagnostic pathway in the evaluation and management of coronary artery disease (CAD).

According to the company, FFR_CT is part of a clinical pathway for the evaluation and diagnosis of CAD that provides clear insight into a patient’s condition with a patient-specific visual model of the heart’s blood flow, helping physicians make more accurate diagnoses and treatment decisions.

The FISH&CHIPS study was conducted in the United Kingdom by the National Health Service (NHS) England. The study, which was funded by the United Kingdom’s Medical Research Council (MRC), was designed to assess the impact of the HeartFlow FFR_CT to a CCTA-first diagnostic pathway at a national level.

Principal Investigator Tim Fairbairn, MBChB, FRCP, PhD, presented the study’s findings at the European Society of Cardiology’s ESC Congress 2023 held August 25-28 in Amsterdam, the Netherlands. Dr. Fairbairn is Consultant Cardiologist at Liverpool Heart and Chest Hospital in Liverpool, United Kingdom.

HeartFlow stated that the 2-year study analyzed data from 90,553 patients at 25 hospital sites in England. The primary objective of the study is to determine whether a CCTA-with-FFR_CT diagnostic pathway reduces health-related events, time to diagnosis, and overall health care costs compared to a standard-of-care CCTA diagnostic chest pain pathway.

As outlined in the company’s press release, 2-year key outcomes associated with the availability of FFR_CT in FISH&CHIPS include the following:

• A significant 14% relative reduction in cardiovascular mortality and a significant 8% relative reduction in all-cause mortality
• An increase in catheterization lab efficiency, driven by a 5% relative reduction in invasive cardiac angiography (ICA) and an 8% relative increase in percutaneous coronary intervention
• A 14% relative reduction in additional noninvasive heart testing after CCTA
• High prognostic value for FFR_CT whereby patients with severely abnormal FFR_CT values (≤ 0.50) had a 2x risk of all-cause death and a 3x risk of nonfatal myocardial infarction compared to patients with normal FFR_CT values

Campbell Rogers, MD, Chief Medical Officer of HeartFlow, commented in the company’s press release, “The foresight and continued leadership of NHS England in challenging the status quo and implementing new approaches like the CCTA+FFR_CT pathway has a widespread impact on the industry globally.

“The nationwide CCTA-first approach for evaluating patients with possible cardiovascular disease has become the model of both clinical efficacy and efficiency, which is why clinical guidelines across the globe have adopted it.

“FISH&CHIPS demonstrates that NHS England’s decision to incorporate the HeartFlow FFR_CT analysis into that pathway extended the lives of many English patients and ensured efficient and effective use of noninvasive and invasive testing and treatment.”

Also in the press release, Professor Enitan Carrol, MBChB, MRCP, FRCPCH, MD, who is Clinical Director, Clinical Research Network: North West Coast (CRN NWC) of the National Institute for Health and Care Research (NIHR), stated, “At NIHR CRN NWC, we are delighted to see these impressive results from the FISH&CHIPS study, which shows that the introduction of a new health technology, FFR_CT, at a national level was associated with a reduction in cardiovascular death and invasive angiography. The study was funded by the MRC, which followed on from CRN NWC capacity building support for Dr. Fairbairn as a Research Scholar between 2017 and 2019.”

According to the company, FISH&CHIPS building on results seen in the recent PRECISE protocol, which is a prospective randomized trial of the optimal evaluation of cardiac symptoms and revascularization that compared the noninvasive precision CCTA+FFR_CT pathway to traditional testing. PRECISE proved the CCTA+FFR_CT pathway was a more effective path in guiding and informing treatment. In November 2022, HeartFlow announced that results of PRECISE were presented as late-breaking clinical data at the American Heart Association Scientific Sessions 2022.

FISH&CHIPS confirms and extends these results at a population level, delivering marked improvements in the hard clinical endpoints of all-cause and cardiovascular mortality, extending patients’ lives without adversely impacting other clinical events, stated the company. Additionally, the data reinforce observations from 3-year follow-up of the ADVANCE-DK registry, including the value of attaining FFR_CT information early to assess patient risk effectively, and the relationship between lower FFR_CT values and increased patient risk, advised HeartFlow.

In 2018, HeartFlow announced that the United Kingdom’s National Health Service had adopted the company’s FFR_CT analysis technology as part of the Innovation and Technology Payment program to help physicians better diagnose coronary heart disease.