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非老年患者维生素 K 拮抗剂和直接口服抗凝剂在心房颤动中的应用。

Vitamin K Antagonists and Direct Oral Anticoagulants in Nonagenarian Patients With Atrial Fibrillation.

机构信息

Department of Cardiology, University Hospital Alvaro Cunqueiro, Vigo, Spain.

Department of Cardiology, University Hospital of Leon, Spain.

出版信息

J Am Med Dir Assoc. 2020 Mar;21(3):367-373.e1. doi: 10.1016/j.jamda.2019.08.033. Epub 2019 Nov 19.

Abstract

OBJECTIVES

Nonagenarian patients are underrepresented in clinical trials that have evaluated oral anticoagulation in patients with atrial fibrillation (AF). The aim of this study was to assess the pronostic impact of oral anticoagulation in patients with AF age ≥90 years.

DESIGN

Retrospective multicenter study of nonagenarian patients with AF.

SETTING AND PARTICIPANTS

A total of 1750 nonagenarian inpatients and outpatients with nonvalvular AF between January 2013 and December 2018 in 3 Spanish health areas were studied.

METHODS

Patients were divided into 3 groups based on antithrombotic therapy: nonoral anticoagulants (30.5%), vitamin-K antagonists (VKAs; 28.6%), and direct oral anticoagulants (DOACs; 40.9%). During a mean follow-up of 23.6 ± 6.6 months, efficacy outcomes (death and embolic events) were evaluated using a Cox regression analysis and safety outcomes (bleeding requiring hospitalization) by competing-risk regression. Results were complemented with a propensity score matching analysis.

RESULTS

During follow-up, 988 patients died (56.5%), 180 had embolic events (10.3%), and 186 had major bleeding (10.6%). After multivariable adjustment, DOACs were associated with a lower risk of death and embolic events than nonanticoagulation [hazard ratio (HR) 0.75, 95% confidence interval (CI)] 0.61‒0.92), but VKAs were not (HR 0.87, 95% CI 0.72‒1.05). These results were confirmed after propensity score matching analysis. For bleeding, both DOACs and VKAs proved to be associated with a higher risk (HR for DOAC 1.43; 95% CI 0.97‒2.13; HR for VKA 1.94; 95% CI 1.31‒2.88), although findings for DOACs were not statistically significant (P = .074). For intracranial hemorrhage (ICH), only VKAs-not DOACs-presented a higher risk of ICH (HR 4.43; 95% CI 1.48‒13.31).

CONCLUSIONS AND IMPLICATIONS

In nonagenarian patients with AF, DOACs led to a reduction in mortality and embolic events in comparison with nonanticoagulation. This reduction was not observed with VKAs. Although both DOACs and VKAs increased the risk of bleeding, only VKAs were associated with higher ICH rates.

摘要

目的

在评估非瓣膜性心房颤动(房颤)患者口服抗凝治疗的临床试验中,90 岁以上患者代表性不足。本研究旨在评估≥90 岁房颤患者口服抗凝治疗的预后影响。

设计

回顾性多中心研究,纳入 2013 年 1 月至 2018 年 12 月期间 3 个西班牙卫生区的 1750 名非瓣膜性房颤 90 岁以上住院和门诊患者。

方法

根据抗栓治疗将患者分为 3 组:非口服抗凝剂(30.5%)、维生素 K 拮抗剂(VKAs;28.6%)和直接口服抗凝剂(DOACs;40.9%)。在平均 23.6±6.6 个月的随访期间,采用 Cox 回归分析评估疗效结局(死亡和栓塞事件),采用竞争风险回归分析评估安全性结局(需要住院治疗的出血)。结果通过倾向评分匹配分析进行补充。

结果

随访期间,988 例患者死亡(56.5%),180 例发生栓塞事件(10.3%),186 例发生大出血(10.6%)。多变量调整后,与非抗凝治疗相比,DOACs 与较低的死亡和栓塞风险相关[风险比(HR)0.75,95%置信区间(CI)0.61‒0.92],而 VKAs 则不然(HR 0.87,95% CI 0.72‒1.05)。在倾向评分匹配分析后也得到了同样的结果。对于出血,DOACs 和 VKAs 均与较高的风险相关(DOAC 的 HR 为 1.43;95% CI 0.97‒2.13;VKA 的 HR 为 1.94;95% CI 1.31‒2.88),尽管 DOACs 的结果无统计学意义(P=0.074)。对于颅内出血(ICH),只有 VKAs-而非 DOACs-与更高的 ICH 风险相关(HR 4.43;95% CI 1.48‒13.31)。

结论和意义

在非瓣膜性房颤的 90 岁以上患者中,与非抗凝治疗相比,DOACs 降低了死亡率和栓塞事件的风险。而 VKAs 并未观察到这种降低。虽然 DOACs 和 VKAs 均增加了出血风险,但只有 VKAs 与更高的 ICH 发生率相关。

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