Heartflow, Inc. announced positive data from the DECIDE Registry, demonstrating that their AI-powered Heartflow Plaque Analysis led to treatment modifications for over half of the enrolled patients. This analysis, used in conjunction with coronary computed tomography angiography (CCTA), prompted changes regardless of pre-existing risk factors or CCTA findings. The study, involving roughly 20,000 patients across 30 US sites, is the largest prospective study of its kind.
This development is particularly important for advancing personalized cardiovascular care. The ability to identify and quantify plaque, particularly the higher-risk non-calcified type often missed by traditional CCTA, allows clinicians to make more informed treatment decisions for individual patients, potentially preventing future cardiac events. This moves beyond generalized risk assessments based on factors like age or family history and the limitations of CCTA alone, which primarily detects calcified plaque. This personalized approach has the potential to significantly impact long-term patient outcomes and improve overall cardiovascular health management.
The DECIDE Registry results revealed an average LDL cholesterol reduction of 18.7mg/dL in patients whose management was adjusted based on the Heartflow Plaque Analysis, an improvement associated with a projected 15% reduction in cardiac event risk. Significantly, the analysis also prompted management changes in 30% of patients with zero calcified plaque volume. Furthermore, the study prospectively utilized Heartflow’s Plaque Staging framework, which categorizes patients into four risk stages based on plaque volume and composition. This framework, validated by the FISH&CHIPS Study, offers a practical tool for translating complex plaque analysis data into actionable treatment strategies. Previous data from the FISH&CHIPS study linked higher plaque stages, determined via Heartflow’s analysis, to a five-fold increased risk of cardiovascular events within 3.3 years.
The positive results from the DECIDE Registry strengthen the potential of Heartflow Plaque Analysis to revolutionize coronary artery disease management. By providing a more comprehensive understanding of individual plaque burden, the technology empowers clinicians to implement targeted interventions, potentially leading to earlier and more effective treatment, improved patient outcomes, and a shift towards truly personalized cardiovascular care. The development and implementation of tools like the Plaque Staging framework further support this evolution by providing clear and actionable clinical guidance based on sophisticated AI analysis.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
