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September 20, 2023EP EuropaceOpen Access

Comparisons 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 studies

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Key result

J-ROCKET AF rivaroxaban dosing carries ~30% higher mortality than ROCKET AF criteria in non-Asians.

  • HR 1.30
  • 95% CI 1.05-1.60
  • n=122,453

Why the study?

It was unknown whether the comparable thromboembolism and bleeding risks observed between ROCKET AF and J-ROCKET AF rivaroxaban dosing criteria differ between Asian and non-Asian NVAF patients.

Does rivaroxaban dosing following J-ROCKET AF criteria, off-label underdosing, or off-label overdosing affect the risk of thromboembolism, mortality, and major bleeding compared to ROCKET AF criteria in Asian and non-Asian patients with NVAF?

Comparison

ROCKET AF vs J-ROCKET AF dosing, and off-label underdosing or overdosing vs eligible dosing

Design

Systematic review and random-effects meta-analysis of adjusted observational studies

Authors

YCYi‐Hsin ChanCCChih-Yu ChanSCShao-Wei Chen

Discussion

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Member takes

Overview

May warrant avoiding J-ROCKET AF dosing in non-Asians; challenges broad equivalence and leaves ethnicity-specific criteria open for prospective trials.

Study Design

Type

Meta-Analysis (n=122,453)

Multicenter

Yes

Structured PICO

Does rivaroxaban dosing following J-ROCKET AF criteria, off-label underdosing, or off-label overdosing affect the risk of thromboembolism, mortality, and major bleeding compared to ROCKET AF criteria in Asian and non-Asian patients with NVAF?

P
Population
122,453 patients (67,571 Asian and 54,882 non-Asian) with non-valvular atrial fibrillation (NVAF) from 18 observational studies
I
Intervention
Rivaroxaban following J-ROCKET AF criteria (15 mg/day or 10 mg/day if CrCl < 50 mL/min), off-label underdosing (10 mg/day despite CrCl > 50 mL/min), or off-label overdosing (20 mg/day despite CrCl < 50 mL/min)
C
Comparator
Rivaroxaban following ROCKET AF criteria (20 mg/day or 15 mg/day if CrCl < 50 mL/min) or eligible dosage criteria
O
Outcome
Thromboembolism, all-cause mortality, and major bleedinghard clinical

Main Result

Effect estimate: HR 1.30 (95% CI 1.05-1.60)

J-ROCKET AF dosing criteria may be a suitable alternative for Asian patients with NVAF, but ROCKET AF criteria are more favorable for non-Asians, and off-label dosing generally leads to worse clinical outcomes.

Cite This Study

Chan et al. (2023) conducted a meta-analysis in Non-valvular atrial fibrillation (NVAF) (n=122,453). Rivaroxaban vs. ROCKET AF criteria or eligible dosage criteria was evaluated on All-cause mortality (J-ROCKET AF vs ROCKET AF criteria in non-Asian population) (HR 1.30, 95% CI 1.05-1.60). Rivaroxaban dosing following J-ROCKET AF criteria had higher all-cause mortality than ROCKET AF criteria in non-Asians (HR 1.30; 95% CI 1.05-1.60), with comparable thromboembolism risks in Asians.

synapsesocial.com/papers/6a129ddac031bb6829a6fb9bhttps://doi.org/10.1093/europace/euad288
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Also Consider

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

  1. 1Ischemic stroke, hemorrhage, and mortality in patients with non-valvular atrial fibrillation and renal dysfunction treated with rivaroxaban: sub-analysis of the EXPAND study2021 · 15 citations
  2. 2Outcomes associated with under-dosing of rivaroxaban for management of non-valvular atrial fibrillation in real-world Japanese clinical settings2019 · 52 citations
  3. 3Is a Lower Dose of Rivaroxaban Required for Asians? A Systematic Review of a Population Pharmacokinetics and Pharmacodynamics Analysis of Rivaroxaban2023 · 24 citations
  4. 4Anti-Factor Xa Activity of Standard and Japan-Specific Doses of Rivaroxaban in Thai Patients With Non-Valvular Atrial Fibrillation2020 · 6 citations
  5. 5Outcomes After Use of Standard- and Low-Dose Non–Vitamin K Oral Anticoagulants in Asian Patients With Atrial Fibrillation2018 · 93 citations