Key result
In Asian patients with atrial fibrillation and CrCl ≥50 mL/min, rivaroxaban was associated with a better composite clinical outcome compared with rivaroxaban.
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?
Cohort
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?
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.
Answers are grounded in this paper and cite their sources.
Off-label R15 may underperform R20 for net outcomes in Asian AF with CrCl ≥50; leaves open optimal dosing pending RCTs.
Background and Purpose- Although rivaroxaban 15 mg (R15) was only given to patients with creatinine clearance (CrCl) ≤50 mL/min in the pivotal clinical trial, this dose has been commonly prescribed in Asian patients with nonvalvular atrial fibrillation regardless of renal function. There is a paucity of information on the clinical outcomes of R15 compared with rivaroxaban 20 mg (R20) in patients with CrCl ≥50 mL/min. This study aimed to examine the effectiveness and safety of 2 doses of rivaroxaban in Asian patients with atrial fibrillation and CrCl ≥50 mL/min. Methods- Using the Korean National Health Insurance Service database, patients with atrial fibrillation and normal or mildly impaired renal function (CrCl ≥50 mL/min) and naive to rivaroxaban or warfarin were included from January 2014 to December 2016. Three separate 1:1 propensity score-matched cohorts were conducted: R20 versus warfarin (n=15 584), R15 versus warfarin (n=11 554), and R20 versus R15 (n=10 392). Hazard ratios for ischemic stroke, intracranial hemorrhage, gastrointestinal bleeding, major bleeding, all-cause death, and composite clinical outcome were analyzed. Results- Compared with warfarin, both R20 and R15 showed significantly lower risk for ischemic stroke, major bleeding (mainly through reduction of intracranial hemorrhage), and all-cause death. Compared with R15, R20 showed better results for the composite clinical outcome (hazard ratio, 0.852; 95% CI, 0.735-0.988). This benefit was consistently observed in patients aged ≥80 years and those <50 kg. R20 was associated with higher risk of major bleeding than R15 in patients with marginal CrCl (50-60 mL/min). Conclusions- Among Asians with atrial fibrillation and CrCl ≥50 mL/min, both R20 and R15 were associated with reduced risk of ischemic stroke, intracranial hemorrhage, major bleeding, and all-cause death without significantly increased risk of gastrointestinal bleeding compared with warfarin. In patients with CrCl ≥50 mL/min, on-label R20 showed better results for the composite clinical outcome compared with off-label R15.
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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 was associated with a better composite clinical outcome compared with rivaroxaban.
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