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Outcomes of 10 mg Rivaroxaban in Nonvalvular Atrial Fibrillation Patients With CrCl ≥ 50 mL/min: A Retrospective
Qing Yan1, Yide Yuan1, Jiaqi Liang1
1Department of Cardiovascular Medicine, The Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China.
Insights
Low-dose rivaroxaban (10 mg/day) showed comparable efficacy to standard doses for nonvalvular atrial fibrillation patients in China. This dose also reduced bleeding risk in nonoverweight patients, offering a safer alternative.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Research
Background:
- Standard oral rivaroxaban doses for nonvalvular atrial fibrillation (NVAF) vary globally (20 mg/day in Europe, 15 mg/day in Japan).
- Low-dose rivaroxaban (10 mg/day) is frequently used in China due to bleeding concerns, but its clinical outcomes are not well-established.
- This study investigates the efficacy and safety of low-dose rivaroxaban in Chinese NVAF patients with adequate renal function.
Purpose of the Study:
- To compare the clinical outcomes of low-dose (10 mg/day) versus standard-dose (15-20 mg/day) rivaroxaban in NVAF patients with CrCl ≥ 50 mL/min.
- To evaluate the risks of ischemic stroke (IS) and systemic embolism (SE), as well as bleeding events, between the two dosing groups.
- To explore potential benefits of low-dose rivaroxaban in specific subgroups, such as those with lower BMI.
Main Methods:
- Retrospective study of 1455 NVAF patients with CrCl ≥ 50 mL/min treated between January 2017 and June 2022.
- Patients were categorized into low-dose (10 mg/day) and standard-dose (15 or 20 mg/day) rivaroxaban groups.
- Inverse probability of treatment weighting (IPTW) was applied to balance baseline characteristics; survival analysis was used to compare outcomes.
Main Results:
- No significant difference in the risk of IS+SE was observed between the low-dose and standard-dose groups (HR = 1.01, p = 0.999).
- Similarly, the risk of bleeding events was comparable between the groups (HR = 0.90, p = 0.749).
- Subgroup analysis indicated that low-dose rivaroxaban significantly reduced bleeding risk in nonoverweight patients (BMI < 24 kg/m², HR = 0.53, p = 0.049).
Conclusions:
- For Chinese NVAF patients with CrCl ≥ 50 mL/min, 10 mg/day rivaroxaban is a safe and effective alternative for preventing IS/SE compared to standard doses.
- Low-dose rivaroxaban demonstrates comparable efficacy to standard doses while potentially offering enhanced safety, particularly in nonoverweight individuals.
- These findings support the use of low-dose rivaroxaban in specific NVAF patient populations in China, balancing efficacy with reduced bleeding risk.
Abstract:
Background: The standard oral dose of rivaroxaban for nonvalvular atrial fibrillation (NVAF) patients with a creatinine clearance rate (CrCl) ≥ 50 mL/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/m2, 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/m2), it offers comparable efficacy with enhanced safety.
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