Some of the compounds presented are investigational or are being investigated for uses that have not been approved by the US Food and Drug Administration (FDA), European Medicines Agency (EMA), or other health authorities.
Scientific Congress Publications
Supported by Bayer Pharmaceuticals
ESC 2026
A novel AI-derived digital biomarker for monitoring disease progression in ATTR-CM: first-in-trial use of a computer vision AI-ECG algorithm within a phase 3 pivotal randomized controlled trial
AI-ECG algorithms have emerged as powerful tools to screen for cardiomyopathies such as ATTR-CM; however, the potential of AI-ECG prediction scores to function as a quantitative digital biomarker to track disease burden and progression has not been established.
We report the first deployment of a computer vision AI-ECG algorithm operating directly on ECG images in an RCT involving participants with ATTR-CM in ATTRibute-CM.
An image-based AI-ECG algorithm was applied to baseline ECGs from the ATTRibute-CM study and demonstrated discrimination across clinical subgroups at baseline.
In a post hoc exploratory analysis of Month 30 ECG data, AI-ECG prediction scores were lower among the acoramidis-treated group and higher among the placebo-treated group compared with baseline; however, longitudinal complete-case ECG results may be affected by survival and follow-up ECG availability.
These findings support further investigation of AI-ECG-derived prediction scores as digital biomarkers in clinical trials but require survivor-aware methods before use as a treatment-response measure.
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