Article Impact Level: HIGH Data Quality: STRONG Summary of Circulation, 148(12), 936–946. https://doi.org/10.1161/CIRCULATIONAHA.123.064556 Dr. Rahul Aggarwal et al.
Points
- The research paper introduces the DOAC Score, a novel clinical risk assessment tool for estimating bleeding risk in atrial fibrillation (AF) patients on direct-acting oral anticoagulants (DOACs).
- Data from a comprehensive analysis, including the RE-LY trial and other databases, revealed that 6.8% of AF patients taking dabigatran experienced significant bleeding events during a median follow-up of 1.74 years.
- The DOAC Score was internally validated and demonstrated robust predictive performance with an optimism-corrected C statistic of 0.73. It considers factors such as age, creatinine clearance, stroke history, diabetes, and more.
- The DOAC Score consistently outperformed the widely used HAS-BLED score regarding predictive accuracy across multiple validation cohorts, including GARFIELD-AF, COMBINE-AF, and RAMQ.
- This research highlights the potential of the DOAC Score to enhance clinical decision-making and improve patient care by providing more precise risk stratification for bleeding events among AF patients eligible for DOAC therapy.
Summary
This research paper addresses the limitations of current clinical decision tools for assessing bleeding risk in individuals with atrial fibrillation (AF) who are taking direct-acting oral anticoagulants (DOACs), such as dabigatran, edoxaban, rivaroxaban, and apixaban. The study involved a large cohort of patients from multiple trials and databases to develop and validate a novel clinical risk score known as the DOAC Score. The objective was to personalize bleeding risk estimates for AF patients on DOAC therapy, as existing tools were primarily designed for warfarin-treated individuals.
The researchers conducted an extensive analysis, including data from the RE-LY trial, GARFIELD-AF registry, COMBINE-AF clinical trial cohort, and Quebec Régie de l’Assurance Maladie du Québec and Med-Echo Administrative Databases (RAMQ) administrative database. In the RE-LY trial, out of 5684 patients, 386 (6.8%) experienced significant bleeding within a median follow-up of 1.74 years. After internal validation with bootstrapping, the prediction model developed for the DOAC Score had an optimism-corrected C statistic of 0.73, demonstrating its robust predictive performance. The score incorporated age, creatinine clearance, underweight status, stroke history, diabetes, hypertension, antiplatelet use, nonsteroidal anti-inflammatory use, liver disease, and bleeding history. Importantly, each additional point scored was associated with a 48.7% (95% CI, 38.9%–59.3%; P<0.001) increase in significant bleeding risk in the RE-LY cohort.
Furthermore, the DOAC Score consistently outperformed the commonly used HAS-BLED score regarding predictive accuracy. In the RE-LY trial, the DOAC Score had a significantly higher C statistic (0.73 versus 0.60; P for difference <0.001) than the HAS-BLED score. This superior performance was also observed in other validation cohorts, including GARFIELD-AF (C statistic, 0.71 versus 0.66; P for difference = 0.025), COMBINE-AF (C statistic, 0.67 versus 0.63; P for difference <0.001), and RAMQ (C statistic, 0.65 versus 0.58; P for difference <0.001).
In conclusion, this study comprehensively assesses bleeding risk in individuals with atrial fibrillation potentially eligible for DOAC therapy. The DOAC Score, incorporating multiple clinical variables, offers a more accurate means of stratifying bleeding risk and outperforms the HAS-BLED score in various patient populations. Its potential to enhance clinical decision-making and improve patient care underscores its significance in managing AF patients receiving DOAC treatment.
Link to the article: https://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.123.064556
References Aggarwal, R., Ruff, C. T., Virdone, S., Perreault, S., Kakkar, A. K., Palazzolo, M. G., Dorais, M., Kayani, G., Singer, D. E., Secemsky, E., Piccini, J., Tahir, U. A., Shen, C., & Yeh, R. W. (2023). Development and Validation of the DOAC Score: A Novel Bleeding Risk Prediction Tool for Patients With Atrial Fibrillation on Direct-Acting Oral Anticoagulants. Circulation, 148(12), 936–946. https://doi.org/10.1161/CIRCULATIONAHA.123.064556
