HeartFlow FFR_CT and Plaque Analysis Outcomes Evaluated in Long-Term ADVANCE-DK Data

October 27, 2024—HeartFlow, Inc. announced the 7-year ADVANCE-DK data evaluating the use of HeartFlow’s artificial intelligence–enabled fractional flow reserve CT (FFR_CT) and its Plaque Analysis in the assessment of long-term risk of coronary artery disease in clinically stable, symptomatic patients.

According to the company, the data show that the HeartFlow platform provides clinicians with the information needed to anticipate and mitigate adverse events, including myocardial infarctions, in symptomatic patients with stable chest pain.

The data were presented at TCT 2024, the 36th annual Transcatheter Cardiovascular Therapeutics annual scientific symposium of the Cardiovascular Research Foundation held October 27-30 in Washington, DC.

HeartFlow stated that the ADVANCE-DK data is from a subset of the ADVANCE Registry, which prospectively evaluated the use of a coronary CT angiography (CCTA) and FFR_CT diagnostic pathway in real-world settings to determine the impact on decision-making, downstream invasive coronary angiography, revascularization, and major adverse cardiovascular events.

ADVANCE-DK assessed three patient sets: those with normal FFR_CT, those with subsequent complete revascularization (CR), and those with subsequent incomplete revascularization (IR), noted the company.

The company stated that the 7-year follow-up data from ADVANCE-DK demonstrated that the completeness of revascularization predicts clinical outcomes and can be assessed noninvasively using coronary CCTA and FFR_CT.

As summarized in the press release, the findings included the following:

• Patients with IR, as assessed by FFR_CT, had a higher long-term risk of adverse events than patients whose FFR_CT assessment showed CR or patients who had normal FFR_CT (16.2%, IR vs 7.8%, CR vs 5.7%, normal FFR_CT).
• The combination of plaque quantification and characterization and lesion-specific physiology from FFR_CT is a superior predictor of adverse cardiovascular events, through 7-year follow-up (area under the curve [AUC], 0.73 vs 0.63 inclusive of baseline risk variables plus CCTA).

“We theorized that by leveraging noninvasive FFR_CT we could identify critical issues that had previously gone unnoticed, such as significant coronary lesions that would likely have been mistakenly categorized as visually insignificant,” commented Kristian Tækker Madsen, MD, in the HeartFlow press release.

Dr. Madsen, who is a cardiologist at University Hospital of Southern Denmark in Esbjerg, Denmark, continued, “The prospective data with long-term follow-up in ADVANCE-DK alongside Plaque Analysis data gave us far more than that. FFR_CT remains valuable for patients across all categories, and the combination of FFR_CT and quantitative plaque data, especially after four years of follow up, can offer providers invaluable insight into a patient’s long-term risks informing more personalized and effective treatment plans.”

HeartFlow also stated that a separate study further validated that lesion-specific FFR_CT in patients with non-ST-segment elevation acute coronary syndrome (NSTE-ACS). The study—“Usefulness of FFR_CT to Exclude Hemodynamically Significant Lesions in High-Risk NSTE-ACS”—was presented at TCT 2024 and published concurrently in by David Meier, MD, et al in EuroIntervention.

According to the company, the study found that in the high-risk population studied, the use of CCTA with or without FFR_CT “would have avoided 54% to 64% of unnecessary invasive assessments.”

At the lesion level, FFR_CT far outperformed CCTA alone in identifying significant lesions likely to benefit from revascularization (AUC, 0.84 vs 0.65; P < .01), suggesting an enhanced capability to avoid unnecessary invasive coronary angiography.