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Abstract：
The number of patients with atrial fibrillation is increasing, and frailty prevalence increases with age, posing challenges for physicians in prescribing anticoagulants to such patients because of possible harm. The effects of frailty on anticoagulant therapy in older Japanese patients with nonvalvular atrial fibrillation (NVAF) are unclear. Herein, we prescribed rivaroxaban to Japanese patients with NVAF and monitored for a mean of 2.0 years. The primary endpoint was stroke or systemic embolism. The secondary endpoints were all-cause or cardiovascular death, composite endpoint, and major or non-major bleeding. Frailty was assessed using the Japanese long-term care insurance system. A multiple imputation technique was used for missing data. The propensity score (PS) was obtained to estimate the treatment effect of frailty and was used to create two PS-matched groups. Overall, 5717 older patients had NVAF (mean age: 73.9 years), 485 (8.5%) were classified as frail. After PS matching, background characteristics were well-balanced between the groups. Rivaroxaban dosages were 10 and 15 mg/day for approximately 80% and the remaining patients, respectively. Frailty was not associated with the primary endpoint or secondary endpoints. In conclusion, frailty does not affect the effectiveness or safety of rivaroxaban anticoagulant therapy in older Japanese patients with NVAF.Trial registration: UMIN000019135, NCT02633982.
摘要：
房颤患者的数量在不断增加,虚弱的患病率随着年龄的增长而增加，由于可能造成的伤害，医生在给这些患者开抗凝剂时面临挑战。虚弱对日本老年非瓣膜性心房颤动（NVAF）患者抗凝治疗的影响尚不清楚。在这里，我们给日本NVAF患者开了利伐沙班的处方,平均监测2.0年.主要终点为卒中或全身性栓塞。次要终点是全因死亡或心血管死亡，复合端点，大出血或非大出血。使用日本的长期护理保险制度对虚弱进行了评估。对于缺失的数据使用了多重插补技术。获得倾向评分（PS）以评估虚弱的治疗效果，并用于创建两个PS匹配的组。总的来说,5717名老年患者患有NVAF（平均年龄：73.9岁），485（8.5％）被归类为虚弱。PS匹配后，两组的背景特征平衡良好.利伐沙班剂量为10和15毫克/天，约80％，其余患者，分别。脆弱与主要终点或次要终点无关。总之,虚弱不影响日本老年NVAF患者利伐沙班抗凝治疗的有效性或安全性.试用注册:UMIN000019135,NCT02633982。
