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治疗依从性对心房颤动患者口服抗凝剂有效性和安全性的影响:一项回顾性队列研究。

Impact of treatment adherence on the effectiveness and safety of oral anticoagulants in patients with atrial fibrillation: a retrospective cohort study.

作者信息

Lee Won Kyung, Woo Seong Ill, Hyun Dong Keun, Jung Sun-Young, Kim Mi-Sook, Lee Joongyub

机构信息

Department of Prevention and Management, Inha University Hospital, School of Medicine, Inha University, Incheon, Republic of Korea.

Incheon Regional Cardiocerebrovascular Center, Inha University Hospital, Incheon, Republic of Korea.

出版信息

Eur Heart J Qual Care Clin Outcomes. 2023 Apr 26;9(3):216-226. doi: 10.1093/ehjqcco/qcac023.

Abstract

AIMS

The impact of adherence to oral anticoagulation has not been reported in terms of absolute risk, which would enhance patients' understanding and treatment adherence.

METHODS AND RESULTS

This retrospective cohort study analysed data from the National Health Insurance Database of Korea, from January 2010 to December 2018, on 84 227 patients with non-valvular atrial fibrillation (NVAF). The participants were analysed according to their overall adherence to oral anticoagulants (OACs) and further divided into four groups: non-vitamin K antagonist oral anticoagulant (NOAC) adherent, vitamin K antagonist (VKA) adherent, NOAC non-adherent, and VKA non-adherent. The incidence of ischaemic stroke, major bleeding, and death was compared between the four groups using risk difference, number needed to treat and number needed to harm. Among the participants, 50 178 were adherent to (OACs), while 34 049 were non-adherent. The incidence of major bleeding was higher in the adherent group (4.49%; 95% confidence interval, 4.11-4.85%) than in the non-adherent group (3.61%; 3.16-4.06%), and the incidence of ischaemic stroke was higher in the non-adherent group (7.68%; 7.08-8.33%) than in the adherent group (5.61%; 5.17-6.07%). In terms of risk difference, adherence to OACs increased the risk of major bleeding by 0.87% and decreased the risk of ischaemic stroke by 2.08%. This finding suggests that one additional major bleeding event occurred for every 115 adherent patients, and one additional ischaemic stroke event was prevented for every 48 adherent patients.

CONCLUSION

The benefits of OAC adherence in NVAF patients for ischaemic stroke prevention exceeding the risk of bleeding are shown more clearly in terms of absolute risk.

摘要

目的

尚未有研究以绝对风险的形式报告口服抗凝治疗依从性的影响,而这将增强患者的理解和治疗依从性。

方法与结果

这项回顾性队列研究分析了2010年1月至2018年12月韩国国民健康保险数据库中84227例非瓣膜性心房颤动(NVAF)患者的数据。根据患者对口服抗凝药(OAC)的总体依从性对参与者进行分析,并进一步分为四组:非维生素K拮抗剂口服抗凝药(NOAC)依从组、维生素K拮抗剂(VKA)依从组、NOAC不依从组和VKA不依从组。使用风险差异、治疗所需人数和伤害所需人数比较四组之间缺血性卒中、大出血和死亡的发生率。在参与者中,50178例依从OAC治疗,而34049例不依从。依从组的大出血发生率(4.49%;95%置信区间,4.11 - 4.85%)高于不依从组(3.61%;3.16 - 4.06%),不依从组的缺血性卒中发生率(7.68%;7.08 - 8.33%)高于依从组(5.61%;5.17 - 6.07%)。就风险差异而言,依从OAC治疗使大出血风险增加0.87%,使缺血性卒中风险降低2.08%。这一发现表明,每115例依从患者会额外发生1例大出血事件,每48例依从患者可预防1例额外的缺血性卒中事件。

结论

在NVAF患者中,口服抗凝治疗依从性预防缺血性卒中的益处超过出血风险,这在绝对风险方面表现得更为明显。

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