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依房颤类型和持续时间分析的阿哌沙班与华法林的结局:ARISTOTLE 试验结果。

Outcomes of apixaban vs. warfarin by type and duration of atrial fibrillation: results from the ARISTOTLE trial.

机构信息

Duke Clinical Research Institute, Duke University Medical Center, PO Box 17969, Durham, NC 27715, USA.

出版信息

Eur Heart J. 2013 Aug;34(31):2464-71. doi: 10.1093/eurheartj/eht135. Epub 2013 Apr 17.

Abstract

AIMS

It is uncertain whether the benefit from apixaban varies by type and duration of atrial fibrillation (AF).

METHODS AND RESULTS

A total of 18 201 patients with AF [2786 (15.3%) with paroxysmal and 15 412 (84.7%) with persistent or permanent] were randomized to apixaban or warfarin. In this pre-specified secondary analysis, we compared outcomes and treatment effect of apixaban vs. warfarin by AF type and duration. The primary efficacy endpoint was a composite of ischaemic or haemorrhagic stroke or systemic embolism. The secondary efficacy endpoint was all-cause mortality. There was a consistent reduction in stroke or systemic embolism (P for interaction = 0.71), all-cause mortality (P for interaction = 0.75), and major bleeding (P for interaction = 0.50) with apixaban compared with warfarin for both AF types. Apixaban was superior to warfarin in all studied endpoints, regardless of AF duration at study entry (P for all interactions >0.13). The rate of stroke or systemic embolism was significantly higher in patients with persistent or permanent AF than patients with paroxysmal AF (1.52 vs. 0.98%; P = 0.003, adjusted P = 0.015). There was also a trend towards higher mortality in patients with persistent or permanent AF (3.90 vs. 2.81%; P = 0.0002, adjusted P = 0.066).

CONCLUSION

The risks of stroke, mortality, and major bleeding were lower with apixaban than warfarin regardless of AF type and duration. Although the risk of stroke or systemic embolism was lower in paroxysmal than persistent or permanent AF, apixaban is an attractive alternative to warfarin in patients with AF and at least one other risk factor for stroke, regardless of the type or duration of AF.

摘要

目的

尚不确定抗凝药物依度沙班的获益是否因房颤(AF)类型和持续时间而异。

方法和结果

共纳入 18201 例 AF 患者(2786 例(15.3%)为阵发性,15412 例(84.7%)为持续性或永久性),随机分为依度沙班组或华法林组。本预先设定的次要分析中,我们根据 AF 类型和持续时间比较了依度沙班与华法林的疗效和治疗效果。主要疗效终点为缺血性或出血性卒中和全身性栓塞的复合终点。次要疗效终点为全因死亡率。与华法林相比,依度沙班在两种 AF 类型中均降低了卒中或全身性栓塞(P 交互=0.71)、全因死亡率(P 交互=0.75)和大出血(P 交互=0.50)的发生率。无论研究时 AF 的持续时间如何,依度沙班在所有研究终点上均优于华法林(所有交互 P 值>0.13)。持续性或永久性 AF 患者的卒中或全身性栓塞发生率明显高于阵发性 AF 患者(1.52%比 0.98%;P=0.003,校正后 P=0.015)。持续性或永久性 AF 患者的死亡率也呈上升趋势(3.90%比 2.81%;P=0.0002,校正后 P=0.066)。

结论

无论 AF 类型和持续时间如何,依度沙班降低卒中、死亡率和大出血的风险均优于华法林。尽管阵发性 AF 患者的卒中或全身性栓塞风险低于持续性或永久性 AF 患者,但对于 AF 患者和至少有一个其他卒中危险因素的患者,无论 AF 的类型或持续时间如何,依度沙班都是华法林的一个有吸引力的替代药物。

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