XANTUS: a real-world, prospective, observational study of patients treated with rivaroxaban for stroke prevention in atrial fibrillation.
XANTUS: a real-world, prospective, observational study of patients treated with rivaroxaban for stroke prevention in atrial fibrillation.
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DOI：
10.1093/eurheartj/ehv466
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发表时间：
2016-04-07
影响因子：
39.3
通讯作者：
XANTUS Investigators
中科院分区：
文献类型：
--
作者：
Camm AJ;Amarenco P;Haas S;Hess S;Kirchhof P;Kuhls S;van Eickels M;Turpie AG;XANTUS Investigators
尽管根据临床试验结果，非维生素K拮抗剂口服抗凝剂被推荐用于非瓣膜性房颤（NVAF）患者的卒中预防，但在日常临床实践中，仍需要来自非瓣膜性房颤患者的安全性和疗效数据。XANTUS研究了Xa因子抑制剂利伐沙班在NVAF背景下常规临床使用的安全性和有效性。新开始接受利伐沙班治疗的NVAF患者符合资格，并以≥ 3个月的间隔随访1年，或永久停药后至少30天。所有不良事件（AE）均记录为AE或严重AE;主要结局（包括大出血、症状性血栓栓塞事件[卒中、全身性栓塞、短暂性脑缺血发作和心肌梗死]和全因死亡）由中心裁定。在欧洲、以色列和加拿大的311个中心，有6784例患者接受了利伐沙班治疗。患者平均年龄为71.5岁（范围19-99岁），41%为女性，9.4%记录有重度或中度肾损害（肌酐清除率<50 mL/min）。平均CHADS 2和CHA 2DS 2-VASc评分分别为2.0和3.4; 859例（12.7%）患者的CHA 2DS 2-VASc评分为0或1。平均治疗持续时间为329天。128例患者（2.1起事件/100患者-年）发生治疗后出现的大出血，118例（1.9起事件/100患者-年）死亡，43例（0.7起事件/100患者-年）发生卒中。XANTUS是第一项描述利伐沙班在广泛NVAF患者人群中使用的国际前瞻性观察性研究。在常规临床实践中，接受利伐沙班治疗的患者的卒中和大出血发生率较低。Clinicaltrials.gov：NCT01606995。
Although non-vitamin K antagonist oral anticoagulants are recommended for stroke prevention in patients with non-valvular atrial fibrillation (NVAF) based on clinical trial results, there is a need for safety and efficacy data from unselected patients in everyday clinical practice. XANTUS investigated the safety and efficacy of the Factor Xa inhibitor rivaroxaban in routine clinical use in the NVAF setting. Consecutive consenting patients with NVAF newly started on rivaroxaban were eligible and were followed up at ∼3-month intervals for 1 year, or for at least 30 days after permanent discontinuation. All adverse events (AEs) were recorded as AEs or serious AEs; major outcomes (including major bleeding, symptomatic thromboembolic events [stroke, systemic embolism, transient ischaemic attack, and myocardial infarction], and all-cause death) were centrally adjudicated. There were 6784 patients treated with rivaroxaban at 311 centres in Europe, Israel, and Canada. Mean patient age was 71.5 years (range 19–99), 41% were female, and 9.4% had documented severe or moderate renal impairment (creatinine clearance <50 mL/min). The mean CHADS2 and CHA2DS2-VASc scores were 2.0 and 3.4, respectively; 859 (12.7%) patients had a CHA2DS2-VASc score of 0 or 1. The mean treatment duration was 329 days. Treatment-emergent major bleeding occurred in 128 patients (2.1 events per 100 patient-years), 118 (1.9 events per 100 patient-years) died, and 43 (0.7 events per 100 patient-years) suffered a stroke. XANTUS is the first international, prospective, observational study to describe the use of rivaroxaban in a broad NVAF patient population. Rates of stroke and major bleeding were low in patients receiving rivaroxaban in routine clinical practice. Clinicaltrials.gov: NCT01606995.