Arrhythmias & electrophysiologyMeta-analysis

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

EuropacePublished

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

Authors' conclusion

Rivaroxaban dosing regimen following J-ROCKET criteria may serve as an alternative to ROCKET AF criteria for the Asian population with NVAF, whereas the dosing regimen following ROCKET AF criteria was more favourable for the non-Asian population. The use of rivaroxaban 10 mg despite of CrCl > 50 mL/min was associated with a higher risk of thromboembolism but a lower risk of major bleeding, while use of rivaroxaban 20 mg despite of CrCl < 50 mL/min was associated with worse outcome in most clinical events.

Study context

Population
Asian and non-Asian patients with non-valvular AF treated with rivaroxaban18 studies
Comparison
J-ROCKET AF dosing vs ROCKET AF dosing

Pooled result

J-ROCKET AF vs ROCKET AF dosing, by population

Hazard ratio

1.30

95% CI 1.05–1.60

J-ROCKET AF vs ROCKET AF
HR 1.30 (95% CI 1.05–1.60)

As reported in the abstract

Further pooled results

OutcomeHR (95% CI)
Rivaroxaban 10 mg despite CrCl > 50 mL/min vs eligible dosage, thromboembolism1.64 (1.28–2.11)
Rivaroxaban 20 mg despite CrCl < 50 mL/min vs eligible dosage, thromboembolism and mortality — Rivaroxaban 20 mg despite CrCl < 50 mL/min vs eligible dosage · thromboembolism1.32 (1.09–1.59)
Rivaroxaban 20 mg despite CrCl < 50 mL/min vs eligible dosage, thromboembolism and mortality — Rivaroxaban 20 mg despite CrCl < 50 mL/min vs eligible dosage · mortality1.33 (1.10–1.59)

Safety

OutcomeHR (95% CI)
Major bleeding, off-label dosing vs eligible dosage — Rivaroxaban 10 mg despite CrCl > 50 mL/min vs eligible dosage0.72 (0.57–0.90)
Major bleeding, off-label dosing vs eligible dosage — Rivaroxaban 20 mg despite CrCl < 50 mL/min vs eligible dosage1.26 (1.03–1.53)

Original publication

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. Europace. Published 20 September 2023. doi:10.1093/europace/euad288

Summarised from the published abstract; every number is checked against it