The novel biomarker-based ABC (age, biomarkers, clinical history)-bleeding risk score for patients with atrial fibrillation: a derivation and validation study
Abstract
Background The benefit of oral anticoagulation in atrial fibrillation is based on a balance between reduction in ischaemic stroke and increase in major bleeding. We aimed to develop and validate a new biomarker-based risk score to improve the prognostication of major bleeding in patients with atrial fibrillation. Methods We developed and internally validated a new biomarker-based risk score for major bleeding in 14,537 patients with atrial fibrillation randomised to apixaban versus warfarin in the ARISTOTLE trial and externally validated it in 8468 patients with atrial fibrillation randomised to dabigatran versus warfarin in the RE-LY trial. Plasma samples for determination of candidate biomarker concentrations were obtained at randomisation. Major bleeding events were centrally adjudicated. The predictive values of biomarkers and clinical variables were assessed with Cox regression models. The most important variables were included in the score with weights proportional to the model coefficients. The ARISTOTLE and RE-LY trials are registered with ClinicalTrials.gov, numbers NCT00412984 and NCT00262600, respectively. Findings The most important predictors for major bleeding were the concentrations of the biomarkers growth differentiation factor-15 (GDF-15), high-sensitivity cardiac troponin T (cTnT-hs) and haemoglobin, age, and previous bleeding. The ABC-bleeding score (age, biomarkers [GDF-15, cTnT-hs, and haemoglobin], and clinical history [previous bleeding]) score yielded…
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Older age is one of the most important predictors of both ischaemic stroke and bleeding in AF patients.
“For example, older age is one of the most important predictors of both ischaemic stroke and bleeding in AF patients.386,387”
From 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS (2016) · cites this paper as [387]
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- Authors
- Hijazi, Z., Oldgren, J., Lindbäck, J., Alexander, J. H., Connolly, S. J., Eikelboom, J. W., Ezekowitz, M. D., Held, C., Hylek, E. M., Lopes, R. D., Siegbahn, A., Yusuf, S., Granger, C. B., & Wallentin, L.
- Affiliations
- Uppsala University (SE)
- Duke Clinical Research Institute (US)
- Population Health Research Institute (CA)
- Boston University (US)
- Corresponding author
- Hijazi, Ziad
- ORCID
- Venue
- The Lancet
- Publisher
- Elsevier BV
- Published
- 2016-06
- Volume
- 387
- Issue
- 10035
- Pages
- 2302-2311
- ISSN
- 0099-5355 (ISSN-L)
- 0140-6736
- OpenAlex
- W2332141348
- Cited by
- 490
- References
- 38
- Citations by year
- 2026: 21 · 2025: 31 · 2024: 28 · 2023: 36 · 2022: 60 · 2021: 64 · 2020: 59 · 2019: 52 · 2018: 57 · 2017: 53 · 2016: 28
- FWCI
- 52.31
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- The Lancet (publishedVersion)
- PubMed (publishedVersion)
- Funders
- NIH Clinical Center
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Atrial Fibrillation Management and Outcomes
- Health Sciences › Medicine › Oncology › Inflammatory Biomarkers in Disease Prognosis
- Health Sciences › Medicine › Internal Medicine › Venous Thromboembolism Diagnosis and Management
- Keywords
- atrial fibrillation, major bleeding risk, growth differentiation factor 15, high-sensitivity troponin T, hemoglobin, HAS-BLED score, ORBIT score, apixaban, dabigatran, warfarin, oral anticoagulation, bleeding risk prediction, ARISTOTLE trial, RE-LY trial, outcome prediction
- MeSH terms
- Adult, Aged, Aged, 80 and over, Anticoagulants, Atrial Fibrillation, Female, Hemorrhage, Humans, Male, Middle Aged, Prognosis, Pyrazoles, Pyridones, Risk Factors, Warfarin, Biomarkers, Stroke, Young Adult
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