March 27, 2019Stroke
Optimal Rivaroxaban Dose in Asian Patients With Atrial Fibrillation and Normal or Mildly Impaired Renal Function
Key result
In Asian patients with atrial fibrillation and CrCl ≥50 mL/min, rivaroxaban 20 mg was associated with a better composite clinical outcome compared with rivaroxaban 15 mg (HR 0.852; 95% CI 0.735-0.988).
Why the study?
Rivaroxaban 15 mg is commonly prescribed to Asian AF patients regardless of renal function, but data comparing clinical outcomes of rivaroxaban 15 mg versus 20 mg in patients with CrCl ≥50 mL/min are lacking.
Does on-label rivaroxaban 20 mg improve clinical outcomes compared to off-label rivaroxaban 15 mg or warfarin in Asian patients with atrial fibrillation and creatinine clearance ≥50 mL/min?
Population
Asian patients with AF and CrCl ≥50 mL/min naive to rivaroxaban or warfarin
Comparison
Rivaroxaban 20 mg vs rivaroxaban 15 mg vs warfarin
Design
Retrospective propensity score-matched cohort study
Authors
Discussion
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Overview
Off-label R15 may underperform R20 for net outcomes in Asian AF with CrCl ≥50; leaves open optimal dosing pending RCTs.
Key Points
- This study aims to compare the effectiveness and safety of rivaroxaban 15 mg and 20 mg in Asian patients with atrial fibrillation and normal to mildly impaired renal function.
- Analyzed data from the Korean National Health Insurance Service database from January 2014 to December 2016.
- Included patients with atrial fibrillation and normal or mildly impaired renal function (CrCl ≥50 mL/min) who were naive to rivaroxaban or warfarin.
- Conducted three 1:1 propensity score-matched cohorts: R20 vs warfarin, R15 vs warfarin, and R20 vs R15.
- Both R20 and R15 showed significantly lower risk for ischemic stroke and all-cause death compared to warfarin.
- R20 demonstrated a hazard ratio of 0.852 (95% CI, 0.735-0.988) for the composite clinical outcome compared to R15.
- R20 was associated with a higher risk of major bleeding in patients with marginal CrCl (50-60 mL/min).
Study Design
Type
Cohort
Structured PICO
Does on-label rivaroxaban 20 mg improve clinical outcomes compared to off-label rivaroxaban 15 mg or warfarin in Asian patients with atrial fibrillation and creatinine clearance ≥50 mL/min?
P
Population
Asian patients with atrial fibrillation and CrCl ≥50 mL/min, naive to rivaroxaban or warfarin, analyzed in three propensity score-matched cohorts.
E
Exposure
Rivaroxaban 20 mg (on-label dose) or Rivaroxaban 15 mg (off-label dose)
C
Comparator
Warfarin or the alternative rivaroxaban dose (15 mg or 20 mg)
O
Outcome
Composite clinical outcomecomposite
Main Result
Hazard Ratio: 0.852 (95% CI 0.735–0.988)
In Asian patients with atrial fibrillation and creatinine clearance ≥50 mL/min, on-label rivaroxaban 20 mg is associated with better composite clinical outcomes compared to off-label 15 mg, though it may increase major bleeding risk in those with marginal renal function.
Cite This Study
Lee et al. (2019) conducted a cohort in Atrial fibrillation. Rivaroxaban 20 mg vs. Rivaroxaban 15 mg or Warfarin was evaluated on Composite clinical outcome (HR 0.852, 95% CI 0.735-0.988). In Asian patients with atrial fibrillation and CrCl ≥50 mL/min, rivaroxaban 20 mg was associated with a better composite clinical outcome compared with rivaroxaban 15 mg (HR 0.852; 95% CI 0.735-0.988).