Increasing Very Low-Dose Edoxaban Prescription: Effectiveness and Safety Data of Korean AF Patients

Q: What are the key findings of this study?

Very low-dose edoxaban (15 mg once daily) reduced the expected risk of ischemic stroke, transient ischemic attack, or systemic embolism by 68% in frail Korean patients with atrial fibrillation.

Q: What is the clinical evidence from this study?

Study design: Observational. Population: Atrial fibrillation (n=674). Intervention: Edoxaban vs. Expected event rates based on CHA2DS2-VASc score. Primary outcome: Composite of ischemic stroke, transient ischemic attack, or systemic embolism (RRR 68%, p=<0.001).

Q: What does this research mean for the field?

Very low-dose edoxaban (15 mg once daily) reduces the expected risk of ischemic stroke, transient ischemic attack, or systemic embolism by 68% in frail Korean patients with atrial fibrillation. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

Q: What question did this study set out to answer?

To describe clinical practice patterns, effectiveness, and safety outcomes associated with very low-dose edoxaban (15 mg once daily) in frail patients with atrial fibrillation.

JungMin Choi; S K Yang; So‐Ryoung Lee; Min Soo Cho; Kyung‐Yeon Lee; Hyo‐Jeong Ahn; Soonil Kwon; Myung‐Jin Cha; Jun Kim; Gi‐Byoung Nam; Kee‐Joon Choi; Eue‐Keun Choi; Seil Oh; Gregory Y.H. Lip

doi:10.4070/kcj.2024.0222

November 15, 2024Korean Circulation JournalOpen Access

Increasing Very Low-Dose Edoxaban Prescription: Effectiveness and Safety Data of Korean AF Patients

View Full Paper

Ask AI

Bookmark

Share

Key result

Very low-dose edoxaban linked to ~68% lower thromboembolic risk in frail AF patients.

RRR 68%
P<0.001
n=674

Figures

Graphical abstract published by Korean Circulation Journal — Graphical abstract · Published by Korean Circulation Journal · CC BY-NC

Why the study?

Evidence remains limited regarding the real-world prescription of very low-dose oral anticoagulation among frail patients with AF.

Does very low-dose edoxaban (15 mg once daily) reduce thromboembolic events in frail patients with atrial fibrillation?

Key Points

To describe clinical practice patterns, effectiveness, and safety outcomes associated with very low-dose edoxaban (15 mg once daily) in frail patients with atrial fibrillation.
Retrospective cohort study of patients with atrial fibrillation prescribed edoxaban 15 mg once daily across two tertiary hospitals between 2016 and September 2022.
Thromboembolic and bleeding events were recorded over a median follow-up of 8 months (interquartile range: 3–16 months) and compared against risk-score predictions.
Thromboembolic events occurred in 16 patients (2.3%) and overall bleeding events occurred in 88 patients (13.1%).
Compared to expected baseline risk-score rates, 15 mg edoxaban demonstrated a 61% reduction in ischemic stroke and a 68% reduction in composite ischemic stroke, transient ischemic attack, or systemic embolism.
Major bleeding events increased by 49% relative to expected risk-score rates.

Study Design

Type

Observational (n=674)

Multicenter

Yes

Structured PICO

Does very low-dose edoxaban (15 mg once daily) reduce thromboembolic events in frail patients with atrial fibrillation?

P

Population

674 frail patients with atrial fibrillation (AF) prescribed edoxaban 15 mg once daily in 2 tertiary hospitals. Mean age 78.3, 49.3% women. Key characteristics: 49.7% aged ≥80 years, 50.4% below 60 kg, 40.2% chronic kidney disease, mean CHA₂DS₂-VASc score 3.9, modified HAS-BLED score 2.0.

I

Intervention

Very low-dose edoxaban (15 mg oral once daily)

C

Comparator

Expected event rates based on established risk scoring systems (CHA₂DS₂-VASc and modified HAS-BLED scores); no active control group.

O

Outcome

Thromboembolic events (stroke, transient ischemic attack, systemic embolism) and bleeding events (major bleeding, clinically relevant non-major bleeding, minor bleeding) during follow-uphard clinical

Main Result

Effect estimate: RRR 68%

Absolute Event Rate: 2.5% vs 7.3%

p-value: p=<0.001

In frail Korean patients with atrial fibrillation, very low-dose edoxaban (15 mg daily) reduced thromboembolic events by 68% compared to expected rates, despite a 49% increase in major bleeding.

Limitations

Data collection was limited to South Korea with a small sample size and short to mid-term follow-up period.
Retrospective observational design without a direct control group (single-arm study).
Only patients prescribed edoxaban 15 mg were evaluated, preventing comparison with other doses or untreated patients.
The cause of stroke could not be determined in more than half of the cases due to poor medical conditions.
Lack of data on proton pump inhibitors or H2 blockers, which may have influenced gastrointestinal bleeding rates.

Implication

Should not yet change practice in frail AF; leaves open benefit of very low-dose edoxaban in randomized trials.

Abstract

BACKGROUND AND OBJECTIVES: Evidence remains limited on the real-world prescription of very low-dose oral anticoagulation among frail patients with atrial fibrillation (AF). We described the practice patterns, effectiveness, and safety of very low-dose edoxaban (15 mg once daily). METHODS: Patients with AF prescribed edoxaban 15 mg once daily in 2 tertiary hospitals between 2016 and September 2022 were included. Baseline clinical characteristics and clinical outcomes of interest were thromboembolic and bleeding events. RESULTS: -VASc score was 3.9±1.6, and the modified HAS-BLED score was 2.0±1.1. Between 2016 and 2022, the number of very low-dose edoxaban prescriptions increased. The main reasons for the prescription of very low-dose were low body weight (55.5% below 60 kg), anaemia (62.8%), chronic kidney disease (40.2%), active cancer (15.3%), concomitant anti-platelet use (26.7%), and prior major bleeding (19.7%). During a median follow-up duration of 8 (interquartile range 3-16) months, overall thromboembolic and bleeding events occurred in 16 (2.3%) and 88 (13.1%) patients, respectively. Compared to the expected event rates on the established risk scoring systems, patients receiving very low-dose edoxaban demonstrated a 61% reduction in ischemic stroke, a 68% reduction of ischemic stroke/transient ischemic attack/systemic embolism, whereas a 49% increase in major bleeding. CONCLUSIONS: The prescription of very low-dose edoxaban was increased over time, attributable to various clinical factors. The use of very low-dose edoxaban reduced the expected risk of thromboembolic events.

Discussion

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

Cite This Study

Choi et al. (2024) conducted an observational in Atrial fibrillation (n=674). Edoxaban vs. Expected event rates based on CHA2DS2-VASc score was evaluated on Composite of ischemic stroke, transient ischemic attack, or systemic embolism (RRR 68%, p=<0.001). Very low-dose edoxaban (15 mg once daily) reduced the expected risk of ischemic stroke, transient ischemic attack, or systemic embolism by 68% in frail Korean patients with atrial fibrillation.

synapsesocial.com/papers/6a10dc8facd1dbe0646486a3 https://doi.org/10.4070/kcj.2024.0222

Topics

Atrial fibrillation

Anticoagulation in AF

Persistent AF management

View Full Paper

Ask AI

Bookmark

Share

Increasing Very Low-Dose Edoxaban Prescription: Effectiveness and Safety Data of Korean AF Patients

Figures

Key Points

Study Design

Structured PICO

Main Result

Limitations

Implication

Abstract

Discussion

Cite This Study

Topics

Increasing Very Low-Dose Edoxaban Prescription: Effectiveness and Safety Data of Korean AF Patients

Figures

Key Points

Study Design

Structured PICO

Main Result

Limitations

Implication

Abstract

Discussion

Cite This Study

Keep reading

Topics

Keep reading