Kitazono Takanari, Ikeda Takanori, Ogawa Satoshi, Nakagawara Jyoji, Minematsu Kazuo, Miyamoto Susumu, Murakawa Yuji, Cavaliere Mary, Hayashi Yasuhiro, Kidani Yoko, Okayama Yutaka, Sunaya Toshiyuki, Sato Shoichiro, Yamanaka Satoshi
Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan.
Department of Cardiovascular Medicine, Toho University Graduate School of Medicine, Tokyo, Japan.
Heart Vessels. 2020 Mar;35(3):399-408. doi: 10.1007/s00380-019-01487-x. Epub 2019 Sep 6.
Direct oral anticoagulants (DOACs), such as rivaroxaban, reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (NVAF). However, it is still unclear whether the stroke reduction benefit outweighs the bleeding risk in elderly Japanese patients with NVAF. The Xarelto Post-Authorization Safety and Effectiveness Study in Japanese Patients with Atrial Fibrillation (XAPASS) was a real-world, prospective observational, post-marketing surveillance study on the safety and effectiveness of rivaroxaban in Japanese clinical practice. This sub-analysis evaluated the clinical outcomes of elderly patients aged ≥ 75 years. At the 1-year follow-up, there were 4,685 (48.91%) and 4,893 (51.09%) patients aged ≥ 75 and < 75 years, respectively. Safety and effectiveness outcomes were compared between patients aged ≥ 75 years and those aged < 75 years, and among 3 elderly sub-populations (age ranges: 75-79, 80-84, and ≥ 85 years). Patients aged ≥ 75 years had higher rates of major bleeding [2.22 vs. 1.35 events per 100 patient-years, hazard ratio (HR) 1.63, 95% confidence interval (CI) 1.17-2.28] and composite of stroke (ischemic or hemorrhagic)/non-central nervous system (non-CNS) systemic embolism (SE)/myocardial infarction (MI) (2.41 vs. 1.21 events per 100 patient-years, HR 1.97, 95% CI 1.40-2.77) compared to patients aged < 75 years. Intracranial hemorrhage rates were < 1 event per 100 patient-years in both groups (0.85 vs. 0.59 events per 100 patient-years, HR 1.43, 95% CI 0.85-2.40). Kaplan-Meier curves of major bleeding and stroke/non-CNS SE/MI showed that no significant differences of cumulative event rates were identified among the 3 elderly sub-populations. Stepwise Cox regression analyses revealed that creatinine clearance (CrCl) (<50 mL/min), hepatic impairment, and hypertension were specific predictors for major bleeding and no specific predictors were found for stroke/non-CNS SE/MI in patients aged ≥ 75 years. In conclusion, safety and effectiveness event rates were higher in patients aged ≥ 75 years compared with those aged < 75 years, yet, no distinct differences were observed among the 3 elderly sub-populations.
直接口服抗凝剂（DOACs），如利伐沙班，可降低非瓣膜性心房颤动（NVAF）患者中风和全身性栓塞的风险。然而，在老年日本NVAF患者中，中风风险降低的益处是否超过出血风险仍不明确。日本心房颤动患者的利伐沙班上市后安全性和有效性研究（XAPASS）是一项关于利伐沙班在日本临床实践中的安全性和有效性的真实世界、前瞻性观察性上市后监测研究。这项亚分析评估了年龄≥75岁的老年患者的临床结局。在1年随访时，年龄≥75岁和＜75岁的患者分别有4685例（48.91%）和4893例（51.09%）。比较了年龄≥75岁和＜75岁的患者以及3个老年亚组（年龄范围：75 - 79岁、80 - 84岁和≥85岁）之间的安全性和有效性结局。与年龄＜75岁的患者相比，年龄≥75岁的患者主要出血发生率更高[每100患者年2.22次事件对1.35次事件，风险比（HR）1.63，95%置信区间（CI）1.17 - 2.28]，中风（缺血性或出血性）/非中枢神经系统（非CNS）全身性栓塞（SE）/心肌梗死（MI）的复合发生率更高（每100患者年2.41次事件对1.21次事件，HR 1.97，95% CI 1.40 - 2.77）。两组颅内出血发生率均＜每100患者年1次事件（每100患者年0.85次事件对0.59次事件，HR 1.43，95% CI 0.85 - 2.40）。主要出血和中风/非CNS SE/MI的Kaplan - Meier曲线显示，3个老年亚组之间未发现累积事件发生率有显著差异。逐步Cox回归分析显示，肌酐清除率（CrCl）（＜50 mL/min）、肝功能损害和高血压是年龄≥75岁患者主要出血的特异性预测因素，而在年龄≥75岁患者中未发现中风/非CNS SE/MI的特异性预测因素。总之，年龄≥75岁的患者与年龄＜75岁的患者相比，安全性和有效性事件发生率更高，但在3个老年亚组之间未观察到明显差异。
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