J Korean Med Sci.  2024 Mar;39(8):e72. 10.3346/jkms.2024.39.e72.

Comparison of High- and Low-Dose Rivaroxaban Regimens in Elderly East Asian Patients With Atrial Fibrillation

• Kim JY
• Kim J
• Park SJ
• Park KM
• Kim JS
• Kim SH
• Shim J
• Choi EK
• Kim DH
• Oh IY
• On YK
• on behalf of the XAIENT Study Group

• KMID: 2553325
• DOI: http://doi.org/10.3346/jkms.2024.39.e72

Abstract

Background
In the Rivaroxaban Once-daily oral direct factor Xa inhibition Compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF) trial, rivaroxaban 20 mg was the on-label dose, and the dose-reduction criterion for rivaroxaban was a creatinine clearance of < 50 mL/min. Some Asian countries are using reduced doses label according to the J-ROCKET AF trial. The aim of this study was to assess the safety and efficacy of a high-dose rivaroxaban regimen (HDRR, 20/15 mg) and low-dose rivaroxaban regimen (LDRR, 15/10 mg) among elderly East Asian patients with atrial fibrillation (AF) in real-world practice.
Methods
This study was a multicenter, prospective, non-interventional observational study designed to evaluate the efficacy and safety of rivaroxaban in AF patients > 65 years of age with or without renal impairment.
Results
A total of 1,093 patients (mean age, 72.8 ± 5.8 years; 686 [62.9%] men) were included in the analysis, with 493 patients allocated to the HDRR group and 598 patients allocated to the LDRR group. A total of 765 patients received 15 mg of rivaroxaban (203 in the HDRR group and 562 in the LDRR group). There were no significant differences in the incidence rates of major bleeding (adjusted hazard ratio [HR], 0.64; 95% confidential interval [CI], 0.21–1.93), stroke (adjusted HR, 3.21; 95% CI, 0.54–19.03), and composite outcomes (adjusted HR, 1.13; 95% CI, 0.47–2.69) between the HDRR and LDRR groups.
Conclusion
This study revealed the safety and effectiveness of either dose regimen of rivaroxaban in an Asian population for stroke prevention of AF. Considerable numbers of patients are receiving LDRR therapy in real-world practice in Asia. Both regimens were safe and effective for these patients.

Keyword

Atrial Fibrillation; Stroke; Bleeding; Asian; Rivaroxaban Dose Regimen

Figure

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  Fig. 1 Flowchart of patient selection.AF = atrial fibrillation.

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  Fig. 2 Kaplan–Meier curves of the study outcomes. (A) Major bleeding, (B) Stroke, and (C) Composite outcome. Green indicates the low-dose rivaroxaban regimen group and blue indicates the high-dose rivaroxaban regimen group.

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  Fig. 3 HRs of the composite outcome according to subgroups.HR = hazard ratio, CI = confidential interval, CrCl = creatinine clearance, LDRR = low-dose rivaroxaban regimen, HDRR = high-dose rivaroxaban regimen.

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