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80 岁及以上伴有房颤的患者在“真实世界”全国注册研究中直接抗凝剂与维生素 K 拮抗剂的比较:来自 FANTASIIA 研究的见解。

Direct Anticoagulants Versus Vitamin K Antagonists in Patients Aged 80 Years or Older With Atrial Fibrillation in a "Real-world" Nationwide Registry: Insights From the FANTASIIA Study.

机构信息

Cardiology Department, University Hospital Reina Sofia, Córdoba, Spain.

Instituto Universitario de Ciencias de la Salud, A Coruña, Spain.

出版信息

J Cardiovasc Pharmacol Ther. 2020 Jul;25(4):316-323. doi: 10.1177/1074248420916316. Epub 2020 Mar 31.

Abstract

OBJECTIVE

To describe major events at follow up in octogenarian patients with atrial fibrillation (AF) according to anticoagulant treatment: direct oral anticoagulants (DOACs) versus vitamin K antagonists (VKAs).

METHODS

A total of 578 anticoagulated patients aged ≥80 years with AF were included in a prospective, observational, multicenter study. Basal features, embolic events (stroke and systemic embolism), severe bleedings, and all-cause mortality at follow up were investigated according to the anticoagulant treatment received.

RESULTS

Mean age was 84.0 ± 3.4 years, 56% were women. Direct oral anticoagulants were prescribed to 123 (21.3%) patients. Compared with 455 (78.7%) patients treated with VKAs, those treated with DOACs presented a lower frequency of permanent AF (52.9% vs 61.6%, = .01), cancer history (4.9% vs 10.9%, = .046), renal failure (21.1% vs 32.2%, = .02), and left ventricular dysfunction (2.4% vs 8.0%, = .03); and higher frequency of previous stroke (26.0% vs 16.6%, = .02) and previous major bleeding (8.1% vs 3.6%, = .03). There were no significant differences in Charlson, CHA2DS2VASc, nor HAS-BLED scores. At 3-year follow up, rates of embolic events, severe bleedings, and all-cause death (per 100 patients-year) were similar in both groups (DOACs vs VKAs): 0.34 vs 1.35 ( = .15), 3.45 vs 4.41 ( = .48), and 8.2 vs 11.0 ( = .18), respectively, without significant differences after multivariate analysis (hazard ratio [HR]: 0.25, 95% confidence interval [CI]: 0.03-1.93, = .19; HR: 0.88, 95% CI: 0.44-1.76, = .72 and HR: 0.84, 95% CI: 0.53-1.33, = .46, respectively).

CONCLUSION

In this "real-world" registry, the differences in major events rates in octogenarians with AF were not statistically significant in those treated with DOACs versus VKAs.

摘要

目的

根据抗凝治疗,描述 80 岁以上心房颤动(AF)患者随访时的主要事件:直接口服抗凝剂(DOACs)与维生素 K 拮抗剂(VKAs)。

方法

共纳入 578 例年龄≥80 岁的接受抗凝治疗的 AF 患者,前瞻性、观察性、多中心研究。根据接受的抗凝治疗,调查随访时的栓塞事件(中风和全身性栓塞)、严重出血和全因死亡率等基本特征。

结果

平均年龄为 84.0±3.4 岁,56%为女性。123 例(21.3%)患者接受 DOACs 治疗。与 455 例(78.7%)接受 VKA 治疗的患者相比,接受 DOACs 治疗的患者永久性 AF 发生率较低(52.9% vs. 61.6%, =.01),癌症病史(4.9% vs. 10.9%, =.046),肾功能衰竭(21.1% vs. 32.2%, =.02)和左心室功能障碍(2.4% vs. 8.0%, =.03);而既往中风(26.0% vs. 16.6%, =.02)和既往大出血(8.1% vs. 3.6%, =.03)发生率较高。Charlson、CHA2DS2VASc 和 HAS-BLED 评分无显著差异。在 3 年随访时,两组的栓塞事件、严重出血和全因死亡率(每 100 例患者年)相似(DOACs 组与 VKA 组):0.34 与 1.35( =.15),3.45 与 4.41( =.48)和 8.2 与 11.0( =.18),多变量分析后无显著差异(风险比[HR]:0.25,95%置信区间[CI]:0.03-1.93, =.19;HR:0.88,95% CI:0.44-1.76, =.72 和 HR:0.84,95% CI:0.53-1.33, =.46)。

结论

在这项“真实世界”的研究中,与 VKAs 相比,DOACs 治疗的 80 岁以上 AF 患者的主要事件发生率差异无统计学意义。

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