Division of Cardiology, Internal Medicine, College of Medicine, National Cheng Kung University Hospital, National Cheng Kung University, Tainan, Taiwan.
Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea.
Adv Ther. 2022 Jul;39(7):3316-3333. doi: 10.1007/s12325-022-02102-8. Epub 2022 May 26.
The efficacy and safety of rivaroxaban for the prevention of stroke and systemic embolism have been demonstrated in Asian and non-Asian patients with non-valvular atrial fibrillation (NVAF) in multiple studies. However, limited published data exist on its use specifically in treatment-naïve patients from the Asia region. Patients in South Korea and Taiwan can now receive rivaroxaban as first-line therapy, allowing for data generation in this patient group.
XaMINA was a prospective, real-world, multicenter, single-arm, observational cohort study of patients with NVAF in South Korea and Taiwan naïve to anticoagulation and initiating rivaroxaban. The primary outcome was major bleeding; secondary outcomes included all-cause mortality, symptomatic thromboembolic events, and treatment persistence.
In total, 1094 patients were included and the follow-up was 1 year. The baseline mean CHADS score was 1.63 ± 0.98, mean CHADS-VASc score was 2.92 ± 1.42, and mean HAS-BLED score was 1.00 ± 0.75. The primary outcome occurred in 20 (1.8%) patients [incidence rate 2.1 events per 100 patient-years (95% CI 1.35-3.25)]. Thromboembolic events occurred in 9 (0.8%) patients, of whom 5 (0.5%) had stroke, 3 (0.3%) myocardial infarction, and 1 (0.1%) a transient ischemic attack. There were no cases of non-central nervous system systemic embolism, and 735 (67.2%) patients persisted with rivaroxaban treatment for 1 year.
XaMINA demonstrated low incidence rates of major bleeding events and thromboembolic events in patients with NVAF newly initiating rivaroxaban in South Korea and Taiwan, consistent with previous real-world studies reconfirming the results of the ROCKET AF study.
The trial was registered on ClinicalTrials.gov (identifier NCT03284762) on 15 September 2017.
在多项研究中，亚洲和非亚洲的非瓣膜性心房颤动（NVAF）患者已证实利伐沙班在预防中风和全身性栓塞方面的疗效和安全性。然而，在亚洲地区，关于其在初治患者中的具体应用的有限已发表数据。韩国和台湾的患者现在可以接受利伐沙班作为一线治疗药物，从而可以在该患者群体中生成数据。
XaMINA 是一项前瞻性、真实世界、多中心、单臂、观察性队列研究，纳入了韩国和台湾的初治抗凝且开始使用利伐沙班的 NVAF 患者。主要结局是大出血；次要结局包括全因死亡率、有症状的血栓栓塞事件和治疗持续性。
共纳入 1094 例患者，随访 1 年。基线平均 CHADS 评分为 1.63±0.98，平均 CHADS-VASc 评分为 2.92±1.42，平均 HAS-BLED 评分为 1.00±0.75。主要结局发生在 20 例（1.8%）患者中[发生率为每 100 患者年 2.1 例（95%CI 1.35-3.25）]。血栓栓塞事件发生在 9 例（0.8%）患者中，其中 5 例（0.5%）为中风，3 例（0.3%）为心肌梗死，1 例（0.1%）为短暂性脑缺血发作。无非中枢神经系统的全身性栓塞病例，735 例（67.2%）患者在 1 年内持续接受利伐沙班治疗。
XaMINA 表明，在韩国和台湾，新开始使用利伐沙班的 NVAF 患者的大出血事件和血栓栓塞事件发生率较低，与之前的真实世界研究结果一致，再次证实了 ROCKET AF 研究的结果。
该试验于 2017 年 9 月 15 日在 ClinicalTrials.gov（标识符 NCT03284762）注册。
