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July 10, 2019StrokeOpen Access

Low-Dose Rivaroxaban and Risks of Adverse Events in Patients With Atrial Fibrillation

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Key result

Off-label low-dose rivaroxaban was associated with an increased risk of ischemic stroke compared with on-label dosing in Asian patients with atrial fibrillation (HR 2.75; 95% CI 1.62-4.69; P<0.001).

Why the study?

Low-dose nonvitamin K antagonist oral anticoagulants are commonly used in daily practice among Asian patients with AF, but the risks and net clinical benefit of off-label low-dose versus on-label rivaroxaban required evaluation.

Does off-label low-dose rivaroxaban increase the risk of ischemic stroke or intracranial hemorrhage compared to on-label dosing in Asian patients with atrial fibrillation?

Population

2214 AF patients aged ≥20 years treated with rivaroxaban at a tertiary medical center in Taiwan

Comparison

Off-label low-dose vs on-label dose rivaroxaban

Design

Cohort study

Authors

WCWen‐Han ChengNational Yang Ming Chiao Tung UniversityTCTze‐Fan ChaoNational Yang Ming Chiao Tung UniversityYLYenn‐Jiang LinElectrophysiology

Discussion

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Overview

May support individualized rivaroxaban dosing in Asian AF; leaves open need for randomized confirmation of net benefit.

Key Points

  • The study aims to assess the risks associated with low-dose and on-label dosing of rivaroxaban in Asian patients with atrial fibrillation.
  • Analyzed data from 2214 atrial fibrillation patients treated with rivaroxaban at a tertiary medical center in Taiwan.
  • Divided patients into on-label (n=1630) and off-label low-dose (n=584) groups based on dosing guidelines.
  • Compared risks of ischemic stroke and intracranial hemorrhage between the two dosing groups.
  • Off-label low-dose rivaroxaban was linked to a significantly higher risk of ischemic stroke with an adjusted hazard ratio of 2.75 (95% CI 1.62-4.69, P<0.001).
  • No significant difference in the risk of intracranial hemorrhage was observed between dosing groups (adjusted hazard ratio = 0.62, 95% CI 0.32-1.20, P=0.213).
  • On-label dosing showed a positive net clinical benefit compared to off-label dosing in various weighted models.

Study Design

Type

Cohort (n=2,214)

Multicenter

No

Structured PICO

Does off-label low-dose rivaroxaban increase the risk of ischemic stroke or intracranial hemorrhage compared to on-label dosing in Asian patients with atrial fibrillation?

P
Population
2,214 Asian patients aged ≥20 years with atrial fibrillation treated with rivaroxaban at a tertiary medical center in Taiwan.
E
Exposure
Off-label low-dose rivaroxaban (10 mg/d for patients with an estimated glomerulus filtration rate >50 mL/min)
C
Comparator
On-label dose rivaroxaban (ROCKET-AF or J-ROCKET dosage criteria)
O
Outcome
Ischemic stroke, intracranial hemorrhage, and net clinical benefithard clinical

Main Result

Hazard Ratio: 2.75 (95% CI 1.62–4.69)

p-value: p=<0.001

Off-label low-dose rivaroxaban in Asian patients with atrial fibrillation is associated with a significantly higher risk of ischemic stroke without reducing intracranial hemorrhage compared to on-label dosing.

Cite This Study

Cheng et al. (2019) conducted a cohort in Atrial Fibrillation (n=2,214). Off-label low-dose rivaroxaban vs. On-label dose rivaroxaban was evaluated on Ischemic stroke (HR 2.75, 95% CI 1.62-4.69, p=<0.001). Off-label low-dose rivaroxaban was associated with an increased risk of ischemic stroke compared with on-label dosing in Asian patients with atrial fibrillation (HR 2.75; 95% CI 1.62-4.69; P<0.001).

synapsesocial.com/papers/6a6ea434febe604dd70805dfhttps://doi.org/10.1161/strokeaha.119.025623
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1Benefits and Harms of Low-Dose Rivaroxaban in Asian Patients With Atrial Fibrillation: A Systematic Review and Meta-analysis of Real-World Studies2021 · 9 citations
  2. 2Comparison of High- and Low-Dose Rivaroxaban Regimens in Elderly East Asian Patients With Atrial Fibrillation2024 · 2 citations
  3. 3Comparisons of effectiveness and safety between on-label dosing, off-label underdosing, and off-label overdosing in Asian and non-Asian atrial fibrillation patients treated with rivaroxaban: a systematic review and meta-analysis of observational studies2023 · 18 citations
  4. 4Comparisons of Rivaroxaban Following Different Dosage Criteria (ROCKET AF or J‐ROCKET AF Trials) in Asian Patients With Atrial Fibrillation2019 · 30 citations
  5. 5Primary and key secondary results from the ROCKET AF trial, and their implications on clinical practice2016 · 15 citations