Kim Young-Hoon, Shim Jaemin, Tsai Chia-Ti, Wang Chun-Chieh, Vilela Gilbert, Muengtaweepongsa Sombat, Kurniawan Mohammad, Maskon Oteh, Li Fern Hsu, Nguyen Thang Huy, Thanachartwet Thititat, Sim Kenneth, Camm A John
Korea University Medical Centre Seoul South Korea.
National Taiwan University Hospital Taipei Taiwan.
J Arrhythm. 2018 Jul 6;34(4):418-427. doi: 10.1002/joa3.12073. eCollection 2018 Aug.
ROCKET AF and its East Asian subanalysis demonstrated that rivaroxaban was non-inferior to warfarin for stroke/systemic embolism (SE) prevention in patients with non-valvular atrial fibrillation (NVAF), with a favorable benefit-risk profile. XANAP investigated the safety and effectiveness of rivaroxaban in routine care in Asia-Pacific.
XANAP was a prospective, real-world, observational study in patients with NVAF newly starting rivaroxaban. Patients were followed at ~3-month intervals for 1 year, or for ≥30 days after permanent discontinuation. Primary outcomes were major bleeding events, adverse events (AEs), serious AEs and all-cause mortality; secondary outcomes included stroke/SE. Major outcomes were adjudicated centrally.
XANAP enrolled 2273 patients from 10 countries: mean age was 70.5 years and 58.1% were male. 49.8% of patients received rivaroxaban 20 mg once daily (od), 43.8% 15 mg od and 5.9% 10 mg od. Mean treatment duration was 296 days, and 72.8% of patients had received prior anticoagulation therapy. Co-morbidities included heart failure (20.1%), hypertension (73.6%), diabetes mellitus (26.6%), prior stroke/non-central nervous system SE/transient ischemic attack (32.8%) and myocardial infarction (3.8%). Mean CHADS, CHADS-VASc and HAS-BLED scores were 2.3, 3.7 and 2.1, respectively. The rates (events/100 patient-years [95% confidence interval]) of treatment-emergent major bleeding, stroke and all-cause mortality were 1.5 (1.0-2.1), 1.7 (1.2-2.5) and 2.0 (1.4-2.7), respectively. Persistence was 66.2% at the study end.
The real-world XANAP study demonstrated low rates of stroke and bleeding in rivaroxaban-treated patients with NVAF from Asia-Pacific. The results were consistent with the real-world XANTUS study and ROCKET AF.
ROCKET AF研究及其东亚亚组分析表明，在非瓣膜性心房颤动（NVAF）患者中，利伐沙班在预防卒中/全身性栓塞（SE）方面不劣于华法林，且具有良好的效益风险比。XANAP研究调查了利伐沙班在亚太地区常规治疗中的安全性和有效性。
XANAP是一项针对新开始使用利伐沙班的NVAF患者的前瞻性、真实世界观察性研究。患者每隔约3个月随访1年，或在永久停药后随访≥30天。主要结局为大出血事件、不良事件（AE）、严重AE和全因死亡率；次要结局包括卒中/SE。主要结局由中心判定。
XANAP研究纳入了来自10个国家的2273例患者：平均年龄为70.5岁，58.1%为男性。49.8%的患者接受每日一次20 mg利伐沙班治疗，43.8%接受15 mg每日一次治疗，5.9%接受10 mg每日一次治疗。平均治疗持续时间为296天，72.8%的患者曾接受过抗凝治疗。合并症包括心力衰竭（20.1%）、高血压（73.6%）、糖尿病（26.6%）、既往卒中/非中枢神经系统SE/短暂性脑缺血发作（32.8%）和心肌梗死（3.8%）。CHADS、CHADS-VASc和HAS-BLED评分的平均值分别为2.3、3.7和2.1。治疗中出现的大出血、卒中和全因死亡率的发生率（事件数/100患者年[95%置信区间]）分别为1.5（1.0 - 2.1）、1.7（1.2 - 2.5）和2.0（1.4 - 2.7）。研究结束时的持续用药率为66.2%。
真实世界的XANAP研究表明，亚太地区接受利伐沙班治疗的NVAF患者的卒中和出血发生率较低。结果与真实世界的XANTUS研究和ROCKET AF研究一致。
