Anticoagulation with Edoxaban in Patients with Atrial High-Rate Episodes

Q: What is the clinical evidence from this study?

Study design: RCT. Population: Atrial High-Rate Episodes (AHREs) (n=2536). Intervention: Edoxaban vs. Placebo. Primary outcome: Composite of cardiovascular death, stroke, or systemic embolism (HR 0.81, 95% CI 0.60 to 1.08, p=0.15).

Q: What does this research mean for the field?

Anticoagulation with edoxaban does not significantly reduce the incidence of cardiovascular death, stroke, or systemic embolism compared with placebo in patients with device-detected atrial high-rate episodes. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

Rehan Karim

doi:10.1056/nejmc2312837

December 13, 2023New England Journal of MedicineOpen Access

Anticoagulation with Edoxaban in Patients with Atrial High-Rate Episodes

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Key result

Anticoagulation with edoxaban did not significantly reduce the incidence of cardiovascular death, stroke, or systemic embolism compared to placebo in patients with atrial high-rate episodes.

Why the study?

Does anticoagulation with edoxaban reduce the incidence of cardiovascular death, stroke, or systemic embolism in patients with atrial high-rate episodes detected by implantable devices?

Study Design

Type

RCT (n=2,536)

Blinding

Double-blind

Randomization

1:1

Multicenter

Yes

Structured PICO

Does anticoagulation with edoxaban reduce the incidence of cardiovascular death, stroke, or systemic embolism in patients with atrial high-rate episodes detected by implantable devices?

P

Population

2,536 patients aged 65 years or older with device-detected atrial high-rate episodes and at least one additional stroke risk factor, followed for a median of 21 months.

I

Intervention

Anticoagulation with edoxaban

C

Comparator

Placebo

O

Outcome

Composite of cardiovascular death, stroke, or systemic embolismcomposite

Main Result

Hazard Ratio: 0.81 (95% CI 0.6–1.08)

Absolute Event Rate: 3.2% vs 4%

p-value: p=0.15

Limitations

Premature termination of the trial resulted in insufficient power to detect or rule out a small beneficial effect on stroke prevention.
Generalizability of findings with edoxaban to other non-vitamin K antagonist oral anticoagulants is unknown.
The trial enrolled predominantly White patients in Europe, so results may differ in other racial and ethnic groups.

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Implication

In patients with atrial high-rate episodes, anticoagulation with edoxaban did not reduce the composite of cardiovascular death, stroke, or systemic embolism compared to placebo.

Abstract

To the Editor: Kirchhof et al. (Sept. 28 issue) 1 found that anticoagulation with edoxaban did not reduce the incidence of cardiovascular death, stroke, or systemic embolism as compared with placebo among patients with atrial high-rate episodes (AHREs) detected by implantable devices. In the NOAH-AFNET 6 trial, the incidence of stroke, despite a median CHA 2 DS 2 -VASc score of 4 (on a scale from 0 to 9, with higher scores indicating a greater risk of stroke), was approximately 1% per patient-year. Among patients with atrial fibrillation, anticoagulation is recommended in those who have a minimum of two risk factors for stroke, specifically those . . .

Discussion

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Cite This Study

Rehan Karim (2023) conducted an RCT in Atrial High-Rate Episodes (AHREs) (n=2,536). Edoxaban vs. Placebo was evaluated on Composite of cardiovascular death, stroke, or systemic embolism (HR 0.81, 95% CI 0.60 to 1.08, p=0.15). Anticoagulation with edoxaban did not significantly reduce the incidence of cardiovascular death, stroke, or systemic embolism compared to placebo in patients with atrial high-rate episodes.

synapsesocial.com/papers/6aadf2ced428f1c6be64924e https://doi.org/10.1056/nejmc2312837

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Anticoagulation with Edoxaban in Patients with Atrial High-Rate Episodes

Study Design

Structured PICO

Main Result

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

Anticoagulation with Edoxaban in Patients with Atrial High-Rate Episodes

Study Design

Structured PICO

Main Result

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

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