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90 岁或以上接受口服抗凝剂治疗的心房颤动患者:一项多中心观察性研究。

Patients aged 90 years or older with atrial fibrillation treated with oral anticoagulants: A multicentre observational study.

机构信息

Internal Vascular and Emergency Medicine and Stroke Unit, University of Perugia, Perugia, Italy.

Internal Vascular and Emergency Medicine and Stroke Unit, University of Perugia, Perugia, Italy.

出版信息

Int J Cardiol. 2019 Apr 15;281:56-61. doi: 10.1016/j.ijcard.2019.01.071. Epub 2019 Jan 25.

Abstract

BACKGROUND

Patients aged 90 years or older are often excluded from or under-represented in clinical trials and cohort studies. The clinical benefit of anticoagulation in nonagenarians with atrial fibrillation (AF) remains undefined.

OBJECTIVES

To assess the effectiveness and safety of oral anticoagulants in AF patients aged 90 years or older.

METHODS

Non-valvular AF patients aged 90 years or older receiving direct oral anticoagulants (DOACs) or vitamin K antagonists (VKAs) were included in this observational multicentre study. The primary outcome was the composite of ischaemic stroke/transient ischemic attack (TIA) and systemic embolism (SE). Major bleeding (MB), anticoagulant discontinuation and all-cause death were also assessed. Results are reported as sub-distribution hazard ratios (SHR) with 95% CI, taking death as competing risk.

RESULTS

546 patients were included (301 VKAs retrospective cohort and 245 DOACs prospective cohort; median follow-up 404 days). The rate of ischaemic stroke/TIA/SE was 2.4% patient-year and that of MB 5.5% patient-year. Previous ischaemic stroke/TIA (SHR 3.47; 95% CI 1.54-7.81) and vascular disease (SHR 2.89; 95% CI 1.27-6.60) were independent predictors of ischaemic stroke/TIA/SE. Previous bleeding (SHR 2.53; 95% CI 1.37-4.64) was an independent predictor of MB. The risk of ischaemic stroke/TIA/SE (SHR 0.78, 95% CI 0.30-2.04) or MB (SHR 1.43, 95% CI 0.77-2.65) was not significantly different with DOACs or VKAs.

CONCLUSIONS

In AF nonagenarians receiving anticoagulant treatment, the rate of ischaemic stroke/TIA/SE is relatively low with the drawback of a not negligible rate of MB. DOACs seem a reasonable option for prevention of ischaemic stroke/TIA/SE in this setting.

摘要

背景

90 岁及以上的患者经常被排除在临床试验和队列研究之外,或者代表性不足。抗凝治疗在 90 岁以上伴有心房颤动(AF)的患者中的临床获益尚不清楚。

目的

评估口服抗凝剂在 90 岁及以上 AF 患者中的有效性和安全性。

方法

本观察性多中心研究纳入了 90 岁及以上接受直接口服抗凝剂(DOACs)或维生素 K 拮抗剂(VKAs)的非瓣膜性 AF 患者。主要终点为缺血性卒中和短暂性脑缺血发作(TIA)及全身性栓塞(SE)的复合终点。还评估了大出血(MB)、抗凝药物停药和全因死亡的情况。结果以亚分布风险比(SHR)及 95%可信区间(CI)表示,将死亡作为竞争风险。

结果

共纳入 546 例患者(301 例 VKAs 回顾性队列和 245 例 DOACs 前瞻性队列;中位随访 404 天)。缺血性卒中和 TIA/SE 的发生率为 2.4%患者年,MB 的发生率为 5.5%患者年。既往缺血性卒中和 TIA(SHR 3.47;95%CI 1.54-7.81)和血管疾病(SHR 2.89;95%CI 1.27-6.60)是缺血性卒中和 TIA/SE 的独立预测因素。既往出血(SHR 2.53;95%CI 1.37-4.64)是 MB 的独立预测因素。DOACs 或 VKAs 治疗组缺血性卒中和 TIA/SE(SHR 0.78,95%CI 0.30-2.04)或 MB(SHR 1.43,95%CI 0.77-2.65)的风险无显著差异。

结论

在接受抗凝治疗的 AF 高龄患者中,缺血性卒中和 TIA/SE 的发生率相对较低,但 MB 的发生率不容忽视。DOACs 似乎是该人群预防缺血性卒中和 TIA/SE 的合理选择。

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