Abstract
The approved dose of oral anticoagulant rivaroxaban for patients with non-valvular atrial fibrillation (NVAF) in Japan is 15 mg once daily (od) in patients whose creatinine clearance is ≥ 50 mL/min, but recent real-world studies have demonstrated that these patients often received less than the recommended dose due to bleeding concerns. The effect of under-dosing on safety and effectiveness outcomes remains unclear. We used 1-year follow-up data from the XAPASS, a real-world Japanese prospective, single-arm, observational study. Of the 11,308 patients, 6521 patients who completed a 1-year follow-up and had a creatinine clearance ≥ 50 mL/min were included in this sub-analysis. Primary endpoints were any bleeding and a composite of stroke/non-central nervous system systemic embolism (non-CNS SE)/myocardial infarction (MI). Among the 6521 patients, 4185 (64.2%; mean CHADS2 score: 1.8) received the 15 mg od (recommended dose), whereas 2336 (35.8%; mean CHADS2 score: 2.3) received 10 mg od (under-dose). After adjusting for patient characteristics by propensity scoring and inverse probability of treatment weighting, incidence rates of major bleeding were comparable between under-dosed patients and patients who received the recommended dose (1.34 vs. 1.63 events/100 patient-years, p = 0.197), although the incidence rates of stroke/non-CNS SE/MI were higher in under-dosed patients than in those who received the recommended dose (2.15 vs. 1.48 events/100 patient-years, p = 0.009). In Japanese clinical practice, some NVAF patients receive rivaroxaban doses inconsistent with the recommendation. Considering the total clinical benefit, the recommended dose may be preferable in terms of balance of safety and effectiveness.Clinicaltrials.gov NCT01582737.
Highlights
Atrial fibrillation (AF), one of the most common cardiac arrhythmias in Japan, affects 0.6% of Japanese [1]
Considering the total clinical benefit of non-valvular atrial fibrillation (NVAF) patients, the recommended dose may be preferable in terms of the balance of safety and effectiveness
To reduce the risk of ischemic stroke, direct oral anticoagulants (DOACs) such as rivaroxaban are widely prescribed to patients with AF
Summary
Atrial fibrillation (AF), one of the most common cardiac arrhythmias in Japan, affects 0.6% of Japanese [1]. AF increases the risk of ischemic stroke by fivefold [2]. To reduce the risk of ischemic stroke, direct oral anticoagulants (DOACs) such as rivaroxaban are widely prescribed to patients with AF. Its safety and effectiveness in patients with non-valvular AF (NVAF) were examined in two phase III clinical trials, the worldwide ROCKET AF study [3] and the J-ROCKET AF study [4], which focused on Japanese patients and Japan-specific rivaroxaban dosages. In these studies, rivaroxaban was demonstrated to be non-inferior to warfarin for the prevention of stroke and systemic embolism in ROCKET AF study, and for the principal safety outcome of major and non-major clinical relevant bleeding in J–ROCKET AF study
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