Key result
Low-dose rivaroxaban (10 mg/day) showed no significant difference in ischemic stroke or systemic embolism compared to standard doses (HR 1.01; 95% CI 0.51-1.96; p=0.999).
Why the study?
Low-dose rivaroxaban (10 mg/day) is widely used in China for NVAF due to bleeding concerns, but its impact on clinical outcomes in patients with CrCl ≥ 50 mL/min remains uncertain.
Does low-dose rivaroxaban (10 mg/day) provide comparable efficacy and safety to standard-dose rivaroxaban in preventing ischemic stroke and systemic embolism in Chinese patients with nonvalvular atrial fibrillation and CrCl ≥ 50 mL/min?
Cohort (n=1,455)
No
Does low-dose rivaroxaban (10 mg/day) provide comparable efficacy and safety to standard-dose rivaroxaban in preventing ischemic stroke and systemic embolism in Chinese patients with nonvalvular atrial fibrillation and CrCl ≥ 50 mL/min?
Hazard Ratio: 1.01 (95% CI 0.51–1.96)
Absolute Event Rate: 6.63% vs 4.66%
p-value: p=0.999
In Chinese patients with nonvalvular atrial fibrillation and CrCl ≥ 50 mL/min, off-label low-dose rivaroxaban (10 mg/day) demonstrated comparable efficacy and safety to standard doses.
Supports comparable stroke prevention with low-dose rivaroxaban; leaves open optimal dosing pending randomized trials.
Background: The standard oral dose of rivaroxaban for nonvalvular atrial fibrillation (NVAF) patients with a creatinine clearance rate (CrCl) ≥ 50 m L /min is 20 mg/day in Europe and 15 mg/day in Japan. In the real world, low‐dosing (10 mg/day) rivaroxaban has been widely used in clinical practice in China due to bleeding concerns. However, the impact of low‐dose rivaroxaban on clinical outcomes remains uncertain. Methods: This retrospective study included NVAF patients with CrCl ≥ 50 mL/min treated at the Second Affiliated Hospital of Xi’an Jiaotong University from January 2017 to June 2022. Patients were divided into two groups: standard‐dose (15 or 20 mg/day) and low‐dose (10 mg/day). Inverse probability of treatment weighting (IPTW) was used to balance baseline characteristics. The risk of ischemic stroke (IS)+systemic embolism (SE) and bleeding was compared between the two groups by survival analysis. Results: A total of 1455 patients (mean age: 66.98 ± 11.16 years; 55.95% female) were included. In the low‐dose group ( n = 1176), 78 (6.63%) experienced IS/SE and 68 (5.78%) had bleeding. In the standard‐dose group ( n = 279), 13 (4.66%) experienced IS/SE and 18 (6.45%) had bleeding. Cox regression suggested that compared to the standard‐dose group, patients in the low‐dose group did not show a significantly different risk of IS+SE (HR = 1.01, 95% CI: 0.51–1.96, p = 0.999) or bleeding (HR = 0.90, 95% CI: 0.49–1.67, p = 0.749). Subgroup analysis revealed that for patients with BMI < 24 kg/m 2 , low‐dose rivaroxaban reduced bleeding risk (HR = 0.53, 95% CI: 0.29–0.99, p = 0.049). Conclusion: For NVAF patients with CrCl ≥ 50 mL/min in China, low‐dose rivaroxaban (10 mg/day) is a viable alternative to standard doses in preventing IS/SE. In nonoverweight patients (BMI < 24 kg/m 2 ), it offers comparable efficacy with enhanced safety.
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Yan et al. (2025) conducted a cohort in Nonvalvular atrial fibrillation (NVAF) with CrCl ≥ 50 mL/min (n=1,455). Low-dose rivaroxaban vs. Standard-dose rivaroxaban (15 or 20 mg/day) was evaluated on Ischemic stroke (IS) + systemic embolism (SE) (HR 1.01, 95% CI 0.51-1.96, p=0.999). Low-dose rivaroxaban (10 mg/day) showed no significant difference in ischemic stroke or systemic embolism compared to standard doses (HR 1.01; 95% CI 0.51-1.96; p=0.999).
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