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高龄房颤患者的口服抗凝治疗:一项全国性队列研究。

Oral Anticoagulation in Very Elderly Patients With Atrial Fibrillation: A Nationwide Cohort Study.

机构信息

Division of Cardiology (T.-F.C., Y.-J.L., S.-L.C., L.-W.L., Y.-F.H., T.-C.T., J.-N.L., F.-P.C., S.-A.C.).

Institute of Clinical Medicine, Cardiovascular Research Center (T.-F.C., Y.-J.L., S.-L.C., L.-W.L., Y.-F.H., T.-C.T., J.-N.L., F.-P.C., S.-A.C.).

出版信息

Circulation. 2018 Jul 3;138(1):37-47. doi: 10.1161/CIRCULATIONAHA.117.031658. Epub 2018 Feb 28.

Abstract

BACKGROUND

Stroke prevention with oral anticoagulants (OACs) is the cornerstone for the management of atrial fibrillation (AF). However, data about the use of OACs among patients ≥90 years of age are limited. We aimed to investigate the risk of ischemic stroke and intracranial hemorrhage (ICH) and the net clinical benefit of OAC treatment for very elderly patients with AF (≥90 years of age).

METHODS

This study used the National Health Insurance Research Database in Taiwan. Risks of ischemic stroke and ICH were compared between 11 064 and 14 658 patients with and without AF ≥90 years of age without antithrombotic therapy from 1996 to 2011. Patients with AF (n=15 756) were divided into 3 groups (no treatment, antiplatelet agents, and warfarin), and the risks of stroke and ICH were analyzed. The risks of ischemic stroke and ICH were further compared between patients treated with warfarin and nonvitamin K antagonist OACs (NOACs) from 2012 to 2015 when NOACs were available in Taiwan.

RESULTS

Compared with patients without AF, patients with AF had an increased risk of ischemic stroke (event number/patient number, incidence = 742/11 064, 5.75%/y versus 1399/14 658, 3.00%/y; hazard ratio, 1.93; 95% confidence interval, 1.74-2.14) and similar risk of ICH (131/11 064, 0.97%/y versus 206/14 658, 0.54%/y; hazard ratio, 0.85; 95% confidence interval, 0.66-1.09) in competing risk analysis for mortality. Among patients with AF, warfarin use was associated with a lower stroke risk (39/617, 3.83%/y versus 742/11 064, 5.75%/y; hazard ratio, 0.69; 95% confidence interval, 0.49-0.96 in a competing risk model), with no difference in ICH risk compared with nontreatment. When compared with no antithrombotic therapy or antiplatelet drugs, warfarin was associated with a positive net clinical benefit. These findings persisted in propensity-matched analyses. Compared with warfarin, NOACs were associated with a lower risk of ICH (4/978, 0.42%/y versus 19/768, 1.63%/y; hazard ratio, 0.32; 95% confidence interval, 0.10-0.97 in a competing risk model), with no difference in risk of ischemic stroke.

CONCLUSIONS

Among patients with AF ≥90 years of age, warfarin was associated with a lower risk of ischemic stroke and positive net clinical benefit. Compared with warfarin, NOACs were associated with a lower risk of ICH. Thus, OACs may still be considered as thromboprophylaxis for elderly patients, with NOACs being the more favorable choice.

摘要

背景

口服抗凝剂(OAC)预防中风是心房颤动(AF)管理的基石。然而,关于≥90 岁患者使用 OAC 的数据有限。我们旨在研究 OAC 治疗非常高龄(≥90 岁)AF 患者的缺血性中风和颅内出血(ICH)风险以及净临床获益。

方法

本研究使用了来自中国台湾地区的全民健康保险研究数据库。从 1996 年至 2011 年,比较了 11064 至 14658 名无抗血栓治疗的 AF(≥90 岁)患者与无 AF 患者的缺血性中风和 ICH 风险。将 AF 患者(n=15756)分为 3 组(无治疗、抗血小板药物和华法林),并分析了中风和 ICH 的风险。当 2012 年华法林和新型口服抗凝剂(NOAC)在中国台湾地区可用时,比较了 2012 年至 2015 年接受华法林和非维生素 K 拮抗剂 OAC(NOAC)治疗的患者的缺血性中风和 ICH 风险。

结果

与无 AF 患者相比,有 AF 患者的缺血性中风风险增加(事件数/患者数,发生率=742/11064,5.75%/y 与 1399/14658,3.00%/y;风险比,1.93;95%置信区间,1.74-2.14),但在竞争风险分析中,死亡率的 ICH 风险相似(131/11064,0.97%/y 与 206/14658,0.54%/y;风险比,0.85;95%置信区间,0.66-1.09)。在 AF 患者中,华法林的使用与较低的中风风险相关(39/617,3.83%/y 与 742/11064,5.75%/y;风险比,0.69;95%置信区间,0.49-0.96 在竞争风险模型中),与无治疗相比,ICH 风险无差异。与无抗血栓治疗或抗血小板药物相比,华法林与正向净临床获益相关。在倾向评分匹配分析中,这些发现仍然存在。与华法林相比,NOAC 与较低的 ICH 风险相关(4/978,0.42%/y 与 19/768,1.63%/y;风险比,0.32;95%置信区间,0.10-0.97 在竞争风险模型中),但缺血性中风风险无差异。

结论

在≥90 岁的 AF 患者中,华法林与较低的缺血性中风风险和正向净临床获益相关。与华法林相比,NOAC 与较低的 ICH 风险相关。因此,OAC 仍可被视为老年患者的抗血栓治疗方法,NOAC 是更有利的选择。

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