Beyond HAS-BLED in very elderly patients with atrial fibrillation treated with direct oral anticoagulants: predictors of major bleeding in a real-world cohort

Q: What is the clinical evidence from this study?

Study design: Cohort. Population: Atrial fibrillation (n=487). Intervention: HAS-BLED score. Primary outcome: Major bleeding (OR 0.83, 95% CI 0.55-1.23, p=0.34).

Mustafa Gabarin; Alexander Omelchenko; Yoav Arnson; Karam Abd El Hai; Amer Abu Husseine; Ela Gliadi; Ivan Novikov; Ziad Arow; Ranin Hilu; David Pereg; H Vaknin-Assa; Abid Assali

doi:10.1186/s12872-026-06292-9

August 13, 2026BMC Cardiovascular DisordersOpen Access

Beyond HAS-BLED in very elderly patients with atrial fibrillation treated with direct oral anticoagulants: predictors of major bleeding in a real-world cohort

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Key result

HAS-BLED fails to predict major bleeding in nonagenarians with AF, while apixaban shows less bleeding.

OR 0.83
95% CI 0.55-1.23
P=0.34
n=487

Why the study?

Bleeding risk assessment in very elderly patients with AF receiving DOACs remains challenging, and the HAS-BLED score may have limited applicability in this population.

Does apixaban reduce major bleeding compared to other direct oral anticoagulants in patients aged ≥90 years with atrial fibrillation?

Key Points

To evaluate the predictive accuracy of the HAS-BLED score and identify clinical determinants of major bleeding in patients aged 90 years or older with atrial fibrillation receiving direct oral anticoagulants.
Conducted a retrospective cohort study of 487 consecutive patients aged ≥ 90 years (mean age 93.0 ± 2.6 years, 63.4% female) with atrial fibrillation receiving direct oral anticoagulants, with a median follow-up of 2.9 years.
Evaluated discrimination for the primary outcome of major bleeding using receiver-operating characteristic analysis (AUC) and multivariable logistic regression, confirmed with sensitivity Cox proportional hazards modeling.
Major bleeding occurred in 57 of 487 patients (11.7%), and baseline HAS-BLED score showed poor discrimination (AUC 0.46) with no significant association with bleeding (OR 0.83, 95% CI 0.55–1.23; p = 0.34).
Multivariable analysis identified increasing age (OR 1.14 per year, 95% CI 1.03–1.27; p = 0.014) and anticoagulant selection as independent predictors; compared with apixaban, major bleeding risk was higher with rivaroxaban (OR 3.77, 95% CI 1.65–8.61; p = 0.002) and dabigatran (OR 3.34, 95% CI 1.37–8.16; p = 0.008).
An exploratory clinical model incorporating age, comorbidities, laboratory parameters, and anticoagulant type modestly improved discrimination over HAS-BLED alone (AUC 0.69 vs. 0.46).

Study Design

Type

Cohort (n=487)

Multicenter

No

Structured PICO

Does apixaban reduce major bleeding compared to other direct oral anticoagulants in patients aged ≥90 years with atrial fibrillation?

P

Population

487 very elderly patients (aged ≥90 years) with atrial fibrillation treated with direct oral anticoagulants, followed for a median of 2.9 years.

E

Exposure

Direct oral anticoagulants (apixaban, rivaroxaban, dabigatran, or edoxaban)

C

Comparator

Apixaban (used as the reference standard for anticoagulant type comparisons)

O

Outcome

Major bleeding, defined according to the International Society on Thrombosis and Haemostasis (ISTH) criteriasafety

Main Result

Odds Ratio: 0.83 (95% CI 0.55–1.23)

p-value: p=0.34

Limitations

Retrospective single-center design may limit generalizability
Residual confounding cannot be excluded despite multivariable adjustment
Number of bleeding events limits the complexity of multivariable modeling
Treatment allocation was not randomized, introducing potential confounding by indication
Impact of DOAC dosing (standard vs reduced) was not specifically evaluated
Relatively small number of patients treated with some DOAC agents (e.g., edoxaban) limited statistical power for individual drug comparisons
Important geriatric variables such as frailty, functional status, and cognitive impairment were not systematically captured
Retrospective single-center design
Non-randomized treatment allocation introducing potential confounding by indication
DOAC dosing (standard vs reduced) not specifically evaluated
Geriatric variables such as frailty, functional status, and cognitive impairment were not systematically captured
Limited number of bleeding events restricts the complexity of multivariable modeling

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Implication

In nonagenarians with atrial fibrillation, the HAS-BLED score poorly predicts major bleeding, whereas increasing age and the use of rivaroxaban or dabigatran (compared to apixaban) are strong independent predictors of bleeding risk.

Abstract

Background Bleeding risk assessment in very elderly patients with atrial fibrillation (AF) receiving direct oral anticoagulants (DOACs) remains challenging. The HAS-BLED score is widely used but may have limited applicability in this population. We aimed to evaluate its performance and to identify clinical predictors of major bleeding beyond conventional risk scores. Methods We conducted a retrospective real-world cohort study including consecutive patients aged ≥ 90 years with AF treated with DOACs. The primary outcome was major bleeding. Discrimination was assessed using receiver-operating characteristic (ROC) analysis, and multivariable logistic regression was used to identify predictors and assess incremental value. Results A total of 487 patients (mean age 93.0 ± 2.6 years, 63.4% female) were included, with major bleeding occurring in 57 patients (11.7%). The HAS-BLED score was not associated with major bleeding (OR 0.83, 95% CI 0.55–1.23; p = 0.34) and showed poor discrimination (AUC 0.46). In multivariable analysis, increasing age (OR 1.14 per year, 95% CI 1.03–1.27; p = 0.014) and anticoagulant type were independently associated with bleeding. Compared with apixaban, rivaroxaban (OR 3.77, p = 0.002) and dabigatran (OR 3.34, p = 0.008) were associated with higher bleeding risk. A clinical model incorporating these factors modestly improved discrimination compared with HAS-BLED (AUC 0.69 vs. 0.46). Conclusions In very elderly patients with AF receiving DOAC therapy, HAS-BLED has limited predictive value. Bleeding risk appears to be influenced by treatment-related factors, particularly anticoagulant type. Incorporating these factors may improve risk stratification and support a more individualized approach to anticoagulation management in nonagenarians.

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Cite This Study

Gabarin et al. (2026) conducted a cohort in Atrial fibrillation (n=487). HAS-BLED score was evaluated on Major bleeding (OR 0.83, 95% CI 0.55-1.23, p=0.34). In very elderly patients (≥90 years) with atrial fibrillation, the HAS-BLED score was not associated with major bleeding (OR 0.83), whereas rivaroxaban and dabigatran were associated with higher bleeding risk compared to apixaban.

synapsesocial.com/papers/6a7ee631b70b84ec8b914817 https://doi.org/10.1186/s12872-026-06292-9

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Beyond HAS-BLED in very elderly patients with atrial fibrillation treated with direct oral anticoagulants: predictors of major bleeding in a real-world cohort

Key Points

Study Design

Structured PICO

Main Result

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

Beyond HAS-BLED in very elderly patients with atrial fibrillation treated with direct oral anticoagulants: predictors of major bleeding in a real-world cohort

Key Points

Study Design

Structured PICO

Main Result

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

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