DOAC Score for Predicting Clinical Outcomes After Left Atrial Appendage Closure

Q: What are the key findings of this study?

Patients with a DOAC score >= 10 had a significantly higher rate of the primary composite outcome of death, stroke, and bleeding at 1 year compared to those with lower scores (17.6% vs 12.4%, p=0.01).

Q: What is the clinical evidence from this study?

Study design: Observational. Population: Nonvalvular atrial fibrillation undergoing left atrial appendage closure (n=1464). Intervention: Higher bleeding risk (DOAC score >= 10) vs. Lower bleeding risk (DOAC score < 10). Primary outcome: Composite of all-cause death, stroke, and bleeding events up to 1 year (p=0.01).

Masahiko Asami; Yu Horiuchi; Jun Tanaka; Daiki Yoshiura; Masanori Taniwaki; Kota Komiyama; Hitomi Yuzawa; Kengo Tanabe; Mitsuru Sago; Shuhei Tanaka; Ryuki Chatani; Toru Naganuma; Yohei Ohno; Tomoyuki Tani; Hideharu Okamatsu; Kazuki Mizutani; Yusuke Watanabe; Masaki Izumo; Mike Saji; Shingo Mizuno; Daisuke Hachinohe; Hiroshi Ueno; Shunsuke Kubo; Shinichi Shirai; Masaki Nakashima; Masanori Yamamoto; Kentaro Hayashida

doi:10.1016/j.cjco.2025.01.009

Key result

DOAC score ≥10 linked to ~5-point higher 1-year rate of death, stroke, and bleeding.

P=0.01
n=1,464

Figures

Graphical abstract published by CJC Open — Graphical abstract · Published by CJC Open · CC BY-NC-ND

Why the study?

Data on the DOAC score for assessing bleeding risk in patients undergoing percutaneous LAAC are limited.

Does the DOAC score better predict the composite endpoint of death, stroke, and bleeding compared to the HAS-BLED score in patients with nonvalvular atrial fibrillation undergoing left atrial appendage closure?

Key Points

To assess whether the DOAC score predicts adverse clinical outcomes after percutaneous left atrial appendage closure and compare its prognostic utility against the HAS-BLED score.
Prospective, multicenter observational study (OCEAN-LAAC registry, UMIN000038498) involving 1464 patients with nonvalvular atrial fibrillation undergoing left atrial appendage closure.
Patients were categorized by baseline DOAC score into higher bleeding risk (HBR, n = 923) and lower bleeding risk (LBR, n = 541) groups.
Primary composite endpoint was all-cause death, stroke, and bleeding assessed at 3 months and 1 year.
At 1 year, the primary composite endpoint occurred in 17.6% of the HBR group versus 12.4% of the LBR group (P = 0.01), driven by higher 1-year bleeding events (10.9% vs 7.6%, P = 0.045).
No significant differences were observed between groups for all-cause death (5.2% vs 4.3%, P = 0.49) or stroke (3.6% vs 2.4%, P = 0.28) at 1 year.
The DOAC score significantly enhanced risk prediction over the HAS-BLED score, demonstrated by net reclassification improvement (0.201, 95% CI: 0.069-0.332, P = 0.003) and integrated discrimination improvement (0.006, 95% CI: 0.002-0.010, P = 0.009).

Study Design

Type

Observational (n=1,464)

Multicenter

Yes

Structured PICO

Does the DOAC score better predict the composite endpoint of death, stroke, and bleeding compared to the HAS-BLED score in patients with nonvalvular atrial fibrillation undergoing left atrial appendage closure?

P

Population

1,464 adults with nonvalvular atrial fibrillation at high bleeding risk undergoing percutaneous left atrial appendage closure, followed for 1 year.

E

Exposure

Higher bleeding risk (HBR) categorization based on a DOAC score ≥ 10 at baseline prior to percutaneous left atrial appendage closure.

C

Comparator

Lower bleeding risk (LBR) categorization based on a DOAC score < 10 at baseline prior to percutaneous left atrial appendage closure.

O

Outcome

Composite outcome of all-cause death, stroke, and bleeding events up to 1 year after the intervention.composite

Main Result

Absolute Event Rate: 17.6% vs 12.4%

p-value: p=0.01

Limitations

Observational design inherently limits the ability to establish causal relationships
Follow-up period was limited to 1 year
DOAC score was validated for DOAC therapy and not for VKA, which might not fully account for complex factors in the LAAC population
Observational design limits the ability to establish causal relationships
Follow-up period was limited to 1 year, which may not capture sustained accuracy
DOAC score was validated for DOAC therapy and not for VKA, so it might not fully account for factors influencing bleeding/thromboembolic risk in the LAAC population

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Implication

The DOAC score demonstrates superior clinical utility over the HAS-BLED score in accurately predicting the 1-year composite endpoint of all-cause death, stroke, and bleeding in patients with NVAF undergoing LAAC.

Abstract

Abstract Background The direct-acting oral anticoagulant (DOAC) score has been validated for assessing the bleeding risk in patients with atrial fibrillation (AF). However, data on DOAC scores in patients undergoing percutaneous left atrial appendage closure (LAAC) is limited. This study aimed to evaluate the predictive impact of the DOAC score on clinical events following LAAC and compare it with that of the HAS-BLED (Hypertension, Abnormal renal and liver function, Stroke, Bleeding history or predisposition, Labile international normalized ratio [INR], Elderly [age ≥65 years], Drugs and alcohol concomitantly) score. Methods In this prospective, multicenter, observational study, patients with nonvalvular AF (NVAF) undergoing LAAC were categorized by the DOAC score into higher (HBR) and lower bleeding risk groups. The primary endpoints of all-cause death, stroke, and bleeding were evaluated at 3 months and 1 year. Results Among 1464 patients (mean age 77.1 years; 67.6% male), the HBR group (923 patients) had a lower body mass index, more frequent comorbidities, and higher risk profiles for bleeding and stroke. The device, technical, and procedural success rates were high and similar between groups. At 1 year, the primary endpoint was higher in the HBR group (17.6% vs 12.4%, P = 0.01), influenced by differences in bleeding events (10.9% vs 7.6%, P = 0.045). The DOAC score showed superior predictive value for the primary endpoint compared with the HAS-BLED score. Conclusions The DOAC score is a reliable predictor of composite outcomes, including death, stroke, and bleeding, in patients undergoing LAAC, demonstrating superior utility compared with the HAS-BLED score. This scoring system may improve risk stratification and patient management in daily clinical practice. Clinical Trial Registration UMIN-ID: UMIN000038498 (OCEAN-LAAC registry).

Discussion

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Cite This Study

Asami et al. (2025) conducted an observational in Nonvalvular atrial fibrillation undergoing left atrial appendage closure (n=1,464). Higher bleeding risk (DOAC score >= 10) vs. Lower bleeding risk (DOAC score < 10) was evaluated on Composite of all-cause death, stroke, and bleeding events up to 1 year (p=0.01). Patients with a DOAC score >= 10 had a significantly higher rate of the primary composite outcome of death, stroke, and bleeding at 1 year compared to those with lower scores (17.6% vs 12.4%, p=0.01).

synapsesocial.com/papers/6a20f11176382611e518230b https://doi.org/10.1016/j.cjco.2025.01.009

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DOAC Score for Predicting Clinical Outcomes After Left Atrial Appendage Closure

Figures

Key Points

Study Design

Structured PICO

Main Result

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

DOAC Score for Predicting Clinical Outcomes After Left Atrial Appendage Closure

Figures

Key Points

Study Design

Structured PICO

Main Result

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

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