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March 16, 2021Heart and VesselsOpen Access

Ischemic stroke, hemorrhage, and mortality in patients with non-valvular atrial fibrillation and renal dysfunction treated with rivaroxaban: sub-analysis of the EXPAND study

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Key result

In Japanese patients with non-valvular atrial fibrillation treated with rivaroxaban, renal dysfunction was associated with a significantly higher incidence of stroke or systemic embolism compared to normal renal function (1.47%/year vs. 0.85%/year).

Why the study?

This sub-analysis investigated the effectiveness and safety of rivaroxaban in Japanese NVAF patients based on baseline creatinine clearance levels and prescribed rivaroxaban doses.

Does inappropriate dosing of rivaroxaban affect the risk of stroke, bleeding, and mortality in Japanese patients with non-valvular atrial fibrillation and varying renal function?

Population

6806 Japanese NVAF patients with baseline CrCl data

Comparison

Dosing according to renal function (CrCl ≥ 50 mL/min vs CrCl < 50 mL/min)

Design

Observational sub-analysis with propensity score matching

Authors

HAHirotsugu AtarashiElectrophysiologySUShinichiro UchiyamaUniversité Claude Bernard Lyon 1HIHiroshi InoueKanazawa University

Discussion

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Member takes

Overview

Inappropriate rivaroxaban dosing may raise mortality or bleeding risks by renal function; observational data leave causal effects open.

Study Design

Type

Observational (n=6,806)

Multicenter

Yes

Structured PICO

Does inappropriate dosing of rivaroxaban affect the risk of stroke, bleeding, and mortality in Japanese patients with non-valvular atrial fibrillation and varying renal function?

P
Population
6,806 Japanese patients with non-valvular atrial fibrillation treated with rivaroxaban in routine clinical practice, stratified by renal function and rivaroxaban dose.
E
Exposure
Rivaroxaban (10 mg/day or 15 mg/day)
C
Comparator
Appropriate vs inappropriate dosing based on renal function (under-dose 10 mg/day in normal renal function; over-dose 15 mg/day in renal dysfunction)
O
Outcome
All-cause mortality, major bleeding, and stroke or systemic embolismhard clinical

Main Result

Absolute Event Rate: 1.47% vs 0.85%

p-value: p=<0.001

Appropriate dose reduction of rivaroxaban based on renal function is crucial to balance the risks of bleeding and ischemia in patients with non-valvular atrial fibrillation.

Limitations

  • CrCl values and dose of rivaroxaban at the onset of events were not available
  • Observational study design without assessment of adherence
  • Propensity score matching significantly reduced the sample size
  • Relatively small number of endpoints might have failed to detect clinically important differences in safety

Cite This Study

Atarashi et al. (2021) conducted an observational in Non-valvular atrial fibrillation (n=6,806). Renal dysfunction (CrCl < 50 mL/min) vs. Normal renal function (CrCl ≥ 50 mL/min) was evaluated on Stroke or systemic embolism (p=<0.001). In Japanese patients with non-valvular atrial fibrillation treated with rivaroxaban, renal dysfunction was associated with a significantly higher incidence of stroke or systemic embolism compared to normal renal function (1.47%/year vs. 0.85%/year).

synapsesocial.com/papers/6a97a960cc0e6ba05e76eae4https://doi.org/10.1007/s00380-021-01810-5
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Also Consider

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

  1. 1Prevalence, age distribution, and gender of patients with atrial fibrillation. Analysis and implications1995 · 2,287 citations
  2. 2The EXPAND study: Efficacy and safety of rivaroxaban in Japanese patients with non-valvular atrial fibrillation2018 · 48 citations
  3. 3Rivaroxaban vs. Warfarin in Japanese Patients With Atrial Fibrillation2012 · 645 citations
  4. 4Clinical Outcomes of Off-Label Dosing of Direct Oral Anticoagulant Therapy Among Japanese Patients With Atrial Fibrillation Identified From the SAKURA AF Registry2019 · 83 citations
  5. 5Rivaroxaban versus Warfarin in Nonvalvular Atrial Fibrillation2011 · 9,487 citations