Abstract:

Objective To prospectively explore the safety and efficacy of low-dose rivaroxaban in elderly patients with atrial fibrillation (AF) and renal insufficiency. Methods A total of 79 elderly patients (aged ≥75 years) with non-valvular AF (NVAF) and renal insufficiency admitted from October 2022 to October 2023 were prospectively enrolled. Participants were randomly assigned to the low-dose group (10 mg/day) and the standard-dose group (15 mg/day). Safety and efficacy were evaluated over 6 months of follow-up. Efficacy endpoints consisted of ischemic stroke and peripheral arterial embolism. Safety endpoints included major bleeding and clinically relevant non-major bleeding (e.g., subcutaneous ecchymosis, gingival bleeding, hematuria, fecal occult blood, and conjunctival hemorrhage). Results ①Baseline characteristics showed no significant difference in the CHA2DS2-VASc Score for Atrial Fibrillation Stroke Risk and the HAS-BLED Score for Major Bleeding Risk between groups (P>0.05). However, patients in the low-dose group had a significantly older mean age, fewer cases of prior cerebral infarction/transient ischemic attack (TIA), and lower creatinine clearance compared to the standard-dose group (P<0.05).②Coagulation parameters were analyzed. Pretreatment coagulation index levels were similar between groups (P>0.05). ③Follow-up outcomes did not show new ischemic strokes or peripheral embolisms in either group. Three cases of fecal occult blood, 2 cases of gingival bleeding, and 2 cases of subcutaneous ecchymosis were reported in the standard-dose group. Conclusion Low-dose rivaroxaban demonstrated non-inferior efficacy and a lower bleeding risk compared to standard-dose rivaroxaban in elderly patients with NVAF and renal insufficiency, offering a potential optimization strategy for anticoagulation therapy.

Key words: atrial fibrillation, elderly, renal insufficiency, rivaroxaban, safety and efficacy