Abstract 16694: Impact of Frailty in Non-Valvular Atrial Fibrillation Elderly Patients on Anticoagulation Therapy

Abstract

Background: As the number of elderly people increases, we see more chances to consider anticoagulant therapy for elderly people with frailty. Research Question: Does frailty affect the outcome of anticoagulation therapy? Goals: To show the impact of frailty to the effectiveness and safety of anticoagulant therapy with rivaroxaban in elderly Japanese non-valvular atrial fibrillation (NVAF) patients. Methods: The GENERAL (GENeral practitioners and Embolism pRevention in NVAF patients treated with RivAroxaban: real-Life evidence) study was an observational study of elderly NVAF patients with rivaroxaban at general practice settings in Japan. We employed multiple imputation for missing baseline characteristics, and propensity score (PS) matching to estimate the treatment effect of frailty accounting for the patients’ imbalance. In each imputed and PS matched data set, the treatment effects of frailty were assessed with Cox proportional hazard models for each outcome. Results: A total of 5,717 (mean 79.3 years old, male 64.8%) were observed for a mean of 2.0 years and up to 3 years. Of these, 485 (8.5%) were classified frailty. Variable missing rates ranged from 0% to 35%. After the imputation and matching, the patients' backgrounds were well matched and balanced between two groups. Frailty was not associated with the primary endpoint: stroke/systemic embolism (Hazard Ratio [HR] 1.128, 95% Confidence Interval [CI]: 0.500 - 2.547, p=0.767). Also, frailty was not associated with all-secondary endpoints (Figure 1). In the sensitivity analyses with the complete cases, the cases with any missing variables were deleted, frailty was significantly related with outcome events except for the bleeding events (Figure 2). Conclusion: In our study results, frailty did not affect the effectiveness or safety of anticoagulant therapy with rivaroxaban for this population. However, we should consider the necessity and benefit for this population to start anticoagulant therapy.