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January 1, 2024Journal of Korean Medical ScienceOpen Access

Comparison of High- and Low-Dose Rivaroxaban Regimens in Elderly East Asian Patients With Atrial Fibrillation

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Why the study?

Some Asian countries use reduced-dose rivaroxaban labels based on J-ROCKET AF, prompting the need to assess the safety and efficacy of high-dose versus low-dose rivaroxaban regimens in elderly East Asian AF patients in real-world practice.

Does a high-dose rivaroxaban regimen compared to a low-dose rivaroxaban regimen improve outcomes in elderly East Asian patients with atrial fibrillation?

Population

1,093 AF patients > 65 years of age with or without renal impairment

Comparison

High-dose rivaroxaban regimen (20/15 mg) vs low-dose rivaroxaban regimen (15/10 mg)

Design

Multicenter, prospective, non-interventional observational study

Authors

JKJu Youn KimJKJuwon KimSPSeung‐Jung Park

Discussion

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Member takes

Overview

Both high- and low-dose rivaroxaban regimens were associated with comparable safety and efficacy in elderly East Asians; leaves open optimal dosing for randomized trials.

Structured PICO

Does a high-dose rivaroxaban regimen compared to a low-dose rivaroxaban regimen improve outcomes in elderly East Asian patients with atrial fibrillation?

P
Population
1,093 elderly East Asian patients > 65 years of age with non-valvular atrial fibrillation indicated for oral anticoagulation, CHA2DS2-VASc score > 2, mean age 72.8, 62.9% male. Excluded: history of mechanical valve surgery or moderate to severe mitral stenosis.
I
Intervention
High-dose rivaroxaban regimen (HDRR, 20 mg once daily for CrCl ≥ 50 mL/min and 15 mg once daily for CrCl < 50 mL/min)
C
Comparator
Low-dose rivaroxaban regimen (LDRR, 15 mg once daily for CrCl ≥ 50 mL/min and 10 mg once daily for CrCl < 50 mL/min)
O
Outcome
Composite of ischemic stroke, major bleeding, or all-cause mortalitycomposite

In elderly East Asian patients with atrial fibrillation, both high- and low-dose rivaroxaban regimens demonstrated comparable safety and effectiveness for stroke prevention in real-world practice.

Limitations

  • Non-interventional single-arm observational study
  • Selection of dose regimen left to physician's discretion leading to potential selection bias
  • Relatively low incidence of outcomes compared to other studies

Cite This Study

Kim et al. (2024) studied this question.

synapsesocial.com/papers/6a7e05cfc108c8d3ff0464e1https://doi.org/10.3346/jkms.2024.39.e72
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Also Consider

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

  1. 1Optimal Rivaroxaban Dose in Asian Patients With Atrial Fibrillation and Normal or Mildly Impaired Renal Function2019 · 49 citations
  2. 2Low-Dose Rivaroxaban and Risks of Adverse Events in Patients With Atrial Fibrillation2019 · 57 citations
  3. 3Comparisons of Rivaroxaban Following Different Dosage Criteria (ROCKET AF or J‐ROCKET AF Trials) in Asian Patients With Atrial Fibrillation2019 · 30 citations
  4. 4Benefits and Harms of Low-Dose Rivaroxaban in Asian Patients With Atrial Fibrillation: A Systematic Review and Meta-analysis of Real-World Studies2021 · 9 citations
  5. 5Comparisons 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