Efficacy of 15 mg Edoxaban on Long-Term Outcome after Percutaneous Coronary Intervention in Patients with Atrial Fibrillation and High Bleeding Risk

Q: What is the clinical evidence from this study?

Study design: Cohort. Population: Atrial Fibrillation and Acute Coronary Syndrome (n=148). Intervention: Edoxaban vs. Edoxaban 30 mg. Primary outcome: Composite of ischemic events requiring revascularization, ischemic stroke, or systemic embolism (HR 0.12, 95% CI 0.01-1.17, p=0.09).

Q: What does this research mean for the field?

In older patients with atrial fibrillation and high bleeding risk undergoing percutaneous coronary intervention, 15 mg edoxaban does not significantly differ from 30 mg edoxaban regarding thrombotic or bleeding outcomes. Novelty: ClaimNovelty.NOVEL_FINDING. Consensus alignment: ConsensusAlignment.NEUTRAL.

Takao Sato; Yoshifusa Aizawa; Ryoma Fukuoka; Kazumasa Sugimoto; Takashi Nakayama; Kojiro Tanimoto; Koichiro Sugimura; Yoshihide Fujimoto; Takahiko Kiyooka; Akio Kawamura

doi:10.1536/ihj.25-558

July 13, 2026International Heart JournalOpen Access

Efficacy of 15 mg Edoxaban on Long-Term Outcome after Percutaneous Coronary Intervention in Patients with Atrial Fibrillation and High Bleeding Risk

View Full Paper

Ask AI

Bookmark

Share

Key result

In older patients with atrial fibrillation at high bleeding risk undergoing percutaneous coronary intervention, 15 mg edoxaban did not significantly reduce thrombotic events compared to 30 mg (HR 0.12).

Why the study?

The role of low-dose 15 mg edoxaban compared with the standard 30 mg dose after PCI in patients with AF and high bleeding risk remains unclear.

Does 15 mg edoxaban prevent thrombotic events and reduce bleeding compared with 30 mg edoxaban in older, high bleeding-risk patients with atrial fibrillation undergoing percutaneous coronary intervention?

Key Points

To compare 2-year thrombotic and bleeding outcomes between 15 mg and 30 mg edoxaban in older, high-bleeding-risk patients with atrial fibrillation undergoing percutaneous coronary intervention for acute coronary syndrome.
Retrospectively analyzed 148 patients with atrial fibrillation undergoing percutaneous coronary intervention (PCI) for acute coronary syndrome who received edoxaban 30 mg (n = 99) or 15 mg (n = 49).
Transitioned dual antiplatelet therapy to P2Y12 inhibitor monotherapy during hospital admission at a median of 3 days post-PCI.
Assessed thrombotic and bleeding events over a 2-year follow-up using inverse probability of treatment weighting and weighted Cox proportional hazards regression models.
Major or clinically relevant non-major bleeding occurred in 19.7% of the 30 mg edoxaban group versus 6.8% of the 15 mg group (P = 0.08).
Thrombotic events occurred in 7.4% of patients receiving 30 mg edoxaban compared with 3.0% receiving 15 mg (P = 0.35).

Study Design

Type

Cohort (n=148)

Multicenter

Yes

Structured PICO

Does 15 mg edoxaban prevent thrombotic events and reduce bleeding compared with 30 mg edoxaban in older, high bleeding-risk patients with atrial fibrillation undergoing percutaneous coronary intervention?

P

Population

148 older patients with atrial fibrillation who underwent percutaneous coronary intervention for acute coronary syndrome, evaluated retrospectively over a 2-year follow-up.

E

Exposure

Edoxaban 15 mg once daily, initiated during index hospitalization. Patients received dual antiplatelet therapy (aspirin plus prasugrel or clopidogrel) initially, transitioned to single P2Y12 inhibitor monotherapy within 1 week after PCI, and antiplatelet therapy was discontinued at approximately 12 months. Edoxaban monotherapy continued thereafter.

C

Comparator

Edoxaban 30 mg once daily, initiated during index hospitalization. Patients received dual antiplatelet therapy (aspirin plus prasugrel or clopidogrel) initially, transitioned to single P2Y12 inhibitor monotherapy within 1 week after PCI, and antiplatelet therapy was discontinued at approximately 12 months. Edoxaban monotherapy continued thereafter.

O

Outcome

Composite of ischemic events requiring revascularization, ischemic stroke, or systemic embolism over 2 years. Target lesion failure (composite of cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization) was also evaluated.composite

Main Result

Hazard Ratio: 0.12 (95% CI 0.01–1.17)

Absolute Event Rate: 2.7% vs 7.4%

p-value: p=0.09

In older patients with atrial fibrillation at high bleeding risk undergoing PCI, 15 mg edoxaban demonstrated numerically lower bleeding and comparable thrombotic events compared to standard 30 mg dosing, indicating it may be a safe alternative in this vulnerable population.

Limitations

Retrospective observational study design, which may have introduced selection bias.
Modest sample size and low event rates limit the statistical power of the findings.
Low incidence of ischemic events prevented adequate assessment of the trade-off between ischemic and bleeding risks over time.
Stent type selection was determined by the operator.
The selection of the 15 mg edoxaban dose was based on physician judgment, potentially introducing residual confounding despite statistical adjustment.
Small sample size and low event rates limiting statistical power
Retrospective observational study design, not an event-driven trial
Selection of 15 mg edoxaban based on physician judgment may have introduced selection bias
Unmeasured confounding factors
Stent type selection was determined by the operator

Implication

Should not yet alter edoxaban dosing in older AF patients post-PCI; leaves open optimal dosing in prospective trials.

Abstract

In patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI), dual antiplatelet therapy (DAPT) plus oral anticoagulants increase bleeding risk. Low-dose edoxaban (15 mg) is safe for high-risk older patients with AF; however, its role after PCI compared with the standard 30 mg dose remains unclear. We aimed to compare outcomes of 15 mg and 30 mg edoxaban after PCI.We retrospectively analyzed data from patients with AF undergoing PCI for acute coronary syndrome who received edoxaban 30 mg (n = 99) or 15 mg (n = 49). During admission, DAPT was transitioned to P2Y12 inhibitor monotherapy. Bleeding and thrombotic events were assessed over 2 years, alongside CHADS2, HAS-BLED, and CREDO-Kyoto scores.Compared with 30 mg edoxaban, patients on 15 mg edoxaban were older (86 ± 2 versus 80 ± 6 years, P< 0.01) and had lower hemoglobin levels and body mass index (19.4 ± 3.1 versus 22.7 ± 2.7, P < 0.01) but higher CHADS2 (3.3 ± 0.9 versus 2.8 ± 0.9, P < 0.01), HAS-BLED (3.2 ± 0.9 versus 2.6 ± 0.6, P < 0.01), and CREDO-Kyoto thrombotic and bleeding (5.0 ± 1.1 versus 4.0 ± 1.8, P < 0.01; and 4.1 ± 1.7 versus 2.7 ± 1.2, P < 0.01, respectively) scores. Major bleeding, including clinically relevant non-major bleeding, was more frequent in the 30 mg group (19.7% versus 6.8%, P = 0.08); thrombotic events were comparable (7.4% versus 3.0%, P = 0.35).In weighted Cox analysis, 15 mg edoxaban showed numerically lower hazard ratios for thrombotic (HR: 0.12, 95% CI: 0.01-1.17; P = 0.09) and bleeding (HR: 0.24, 95% CI: 0.06-1.29; P = 0.07) events compared with 30 mg, although these differences did not reach statistical significance.Among older high bleeding-risk patients with AF undergoing PCI, 15 mg edoxaban did not demonstrate superiority over 30 mg with respect to thrombotic or bleeding outcomes.

Discussion

No takes yet. Share an insight, caveat, or question.

Cite This Study

Sato et al. (2026) conducted a cohort in Atrial Fibrillation and Acute Coronary Syndrome (n=148). Edoxaban vs. Edoxaban 30 mg was evaluated on Composite of ischemic events requiring revascularization, ischemic stroke, or systemic embolism (HR 0.12, 95% CI 0.01-1.17, p=0.09). In older patients with atrial fibrillation at high bleeding risk undergoing percutaneous coronary intervention, 15 mg edoxaban did not significantly reduce thrombotic events compared to 30 mg (HR 0.12).

synapsesocial.com/papers/6ad0fc313afa093ea9acfce4 https://doi.org/10.1536/ihj.25-558