Key result
Novel CLIDAS score improves major bleeding discrimination over J-HBR, but shows limited external validity.
Why the study?
Conventional bleeding risk scores after PCI have limited discrimination and external validation.
Does a machine learning-based bleeding risk score improve the prediction of major bleeding compared to conventional risk scores in patients undergoing percutaneous coronary intervention for acute coronary syndrome?
Cohort (n=13,430)
Yes
Does a machine learning-based bleeding risk score improve the prediction of major bleeding compared to conventional risk scores in patients undergoing percutaneous coronary intervention for acute coronary syndrome?
A novel machine learning-based bleeding risk score showed better discrimination than conventional binary classifications in internal validation but had limited external performance, highlighting the challenges of generalizing ML models across different populations.
Limited external validity cautions against clinical adoption of the ML bleeding score; leaves open its value after further validation in PCI patients.
Background: Conventional bleeding risk scores after percutaneous coronary intervention (PCI) have limited discrimination and external validation, so we developed and validated a machine learning (ML)-based bleeding risk score using real-world data. Methods and Results: The primary outcome was major bleeding. In the Clinical Deep Data Accumulation System (CLIDAS) cohort, bleeding events occurring >30 days after PCI were identified by chart review and classified as moderate or severe bleeding by the Global Utilization of Streptokinase and TPA for Occluded Coronary Arteries criteria. In the Health, Clinic, and Education Information Evaluation Institute (HCEI) cohort, major bleeding was identified using ICD-10 codes and Diagnosis Procedure Combination (DPC) data. We analyzed 2,502 acute coronary syndrome patients undergoing PCI from CLIDAS and externally validated the model in 10,928 patients from HCEI. A total of 5 ML algorithms were trained. Key predictors were age, body mass index, Btype natriuretic peptide, and hemoglobin. Logistic regression demonstrated the best performance (area under the curve [AUC] 0.748) and was used to derive the CLIDAS bleeding risk score. The CLIDAS score outperformed the binary J-HBR (AUC 0.74 vs. 0.63, P=0.007) and binary ARC-HBR (AUC 0.74 vs. 0.62, P=0.011), but in external validation the CLIDAS score demonstrated limited discrimination (AUC 0.64), lower than continuous conventional scores. Conclusions: Our novel ML-based bleeding risk score showed better discrimination than conventional binary classifications in the derivation/internal validation, but external performance was limited.
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Tokai et al. (2026) conducted a cohort in Acute coronary syndrome undergoing percutaneous coronary intervention (n=13,430). CLIDAS machine learning-based bleeding risk score vs. Binary J-HBR score was evaluated on Major bleeding (discrimination AUC) (p=0.007). The machine learning-based CLIDAS bleeding risk score demonstrated better discrimination for major bleeding than the binary J-HBR score (AUC 0.74 vs. 0.63) in internal validation, but had limited external validity (AUC 0.64).
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