Institute of Cardiovascular Sciences, University of Birmingham, UHB and Sandwell & West Birmingham Hospitals NHS Trusts, Birmingham, United Kingdom.
Department of Cardiology, Rashid Hospital of Dubai, Dubai, United Arab Emirates.
J Am Coll Cardiol. 2018 Jul 10;72(2):141-153. doi: 10.1016/j.jacc.2018.04.058.
The efficacy of direct oral anticoagulants (DOACs) for stroke prevention in patients with atrial fibrillation (AF) has been established in clinical trials. However, well-conducted, prospective, real-world observational studies of the safety and effectiveness of DOACs are needed.
This study sought to assess the real-world safety profile of rivaroxaban through a pooled analysis of patients with AF enrolled in the XANTUS (Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation) program worldwide.
A pre-planned pooled analysis of the XANTUS, XANAP (Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation in Asia), and XANTUS-EL (Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation in Latin America and EMEA Region) registries was performed. Patients with AF newly starting rivaroxaban for stroke prevention were followed for 1 year. Primary outcomes were treatment-emergent major bleeding, adverse events (AEs)/serious AEs, and all-cause death. Secondary outcomes included treatment-emergent thromboembolic events and nonmajor bleeding. Major outcomes were centrally adjudicated.
Overall, 11,121 patients were included (mean age 70.5 ± 10.5 years; female 42.9%). Comorbidities included heart failure (21.2%), hypertension (76.2%), and diabetes (22.3%). Event rates were: events/100 patient-years: major bleeding 1.7 (95% confidence interval [CI]: 1.5 to 2.0; lowest: Latin America 0.7; highest: Western Europe, Canada, and Israel 2.3); all-cause death 1.9 (95% CI: 1.6 to 2.2; lowest: Eastern Europe 1.5; highest: Latin America, Middle East, and Africa 2.7); and stroke or systemic embolism 1.0 (95% CI: 0.8 to 1.2; lowest: Latin America 0; highest: East Asia 1.8). One-year treatment persistence was 77.4% (lowest: East Asia 66.4%; highest: Eastern Europe 84.4%).
This large, prospective, real-world analysis in 11,121 patients from 47 countries showed low bleeding and stroke rates in rivaroxaban-treated patients with AF, with low treatment discontinuation in different regions of the world. Results were broadly consistent across regions. (Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation [XANTUS]; NCT01606995; Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation in Latin America and EMEA Region [XANTUS-EL]; NCT01800006; and Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation in Asia [XANAP]; NCT01750788).
在临床试验中已证实直接口服抗凝剂（DOACs）在预防房颤（AF）患者中风方面的疗效。然而，需要进行精心设计的、前瞻性的、真实世界的 DOACs 安全性和有效性观察性研究。
本研究通过对全球 XANTUS 计划中接受 AF 治疗的患者进行 Rivaroxaban 的汇总分析，评估 Rivaroxaban 的真实世界安全性概况。
对 XANTUS、XANAP（亚洲 AF 患者预防中风的 Xarelto）和 XANTUS-EL（拉丁美洲和 EMEA 地区 AF 患者预防中风的 Xarelto）登记处进行了预先计划的汇总分析。新开始使用 Rivaroxaban 预防中风的 AF 患者接受了为期 1 年的随访。主要结局是治疗中出现的大出血、不良事件（AE）/严重 AE 和全因死亡。次要结局包括治疗中出现的血栓栓塞事件和非大出血。主要结局是由中心裁定。
共纳入 11121 例患者（平均年龄 70.5±10.5 岁；女性 42.9%）。合并症包括心力衰竭（21.2%）、高血压（76.2%）和糖尿病（22.3%）。事件发生率为：每 100 患者年事件数：大出血 1.7（95%置信区间[CI]：1.5 至 2.0；最低：拉丁美洲 0.7；最高：西欧、加拿大和以色列 2.3）；全因死亡 1.9（95%CI：1.6 至 2.2；最低：东欧 1.5；最高：拉丁美洲、中东和非洲 2.7）；中风或全身性栓塞 1.0（95%CI：0.8 至 1.2；最低：拉丁美洲 0；最高：东亚 1.8）。1 年治疗的持续性为 77.4%（最低：东亚 66.4%；最高：东欧 84.4%）。
这项在来自 47 个国家的 11121 例患者中进行的大型、前瞻性、真实世界分析表明，在接受 Rivaroxaban 治疗的 AF 患者中出血和中风发生率较低，在世界各地的停药率较低。结果在各地区基本一致。（XANTUS：预防房颤患者中风的 Xarelto[NCT01606995]；XANTUS-EL：预防拉丁美洲和 EMEA 地区房颤患者中风的 Xarelto[NCT01800006]；XANAP：预防亚洲房颤患者中风的 Xarelto[NCT01750788]）。
