Objective The aim of this study was to investigate the association between oral anticoagulant type (direct oral anticoagulants (DOACs) vs vitamin K antagonists (VKAs)) and incident dementia or mild cognitive impairment (MCI) among patients with newly diagnosed atrial fibrillation (AF). Methods Using linked electronic health record (EHR) data from the Clinical Practice Research Datalink in the UK, we conducted a historical cohort study among first-time oral anticoagulant users with incident non-valvular AF diagnosed from 2012 to 2018. We compared the incidence of (1) clinically coded dementia and (2) MCI between patients prescribed VKAs and DOACs using Cox proportional hazards regression models, with age as the underlying timescale, accounting for calendar time and time on treatment, sociodemographic and lifestyle factors, clinical comorbidities and medications. Results Of 39 200 first-time oral anticoagulant users (44.6% female, median age 76 years, IQR 68–83), 20 687 (53%) were prescribed a VKA and 18 513 (47%) a DOAC at baseline. Overall, 1258 patients (3.2%) had GP-recorded incident dementia, incidence rate 16.5 per 1000 person-years. DOAC treatment for AF was associated with a 16% reduction in dementia diagnosis compared with VKA treatment in the whole cohort (adjusted HR 0.84, 95% CI: 0.73 to 0.98) and with a 26% reduction in incident MCI (adjusted HR 0.74, 95% CI: 0.65 to 0.84). Findings were similar across various sensitivity analyses. Conclusions Incident EHR-recorded dementia and MCI were less common among patients prescribed DOACs for new AF compared with those prescribed VKAs. This study utilises data from the Clinical Practice Research Datalink, obtained under licence from the UK Medicines and healthcare products regulatory agency. The data is provided by patients and collected by the NHS as part of their care and support. The interpretation and conclusions contained in this study are those of the author/s alone. The data used in this study can only be used for the purposes set out in the submitted and approved ISAC protocol. no data can, therefore, be archived by the research team. Any future research would require a new application to CPRD with data obtained directly from CPRD, subject to their policies for scientific, data governance, and financial approvals (see www.cprd.com).

中文翻译：

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房颤抗凝药处方和痴呆风险


目的 本研究的目的是探讨新诊断心房颤动 (AF) 患者中口服抗凝剂类型（直接口服抗凝剂 (DOAC) 与维生素 K 拮抗剂 (VKA)）与痴呆或轻度认知障碍 (MCI) 之间的关联。方法 使用来自英国临床实践研究数据链的链接电子健康记录 (EHR) 数据，我们对 2012 年至 2018 年诊断出非瓣膜性房颤的首次口服抗凝剂使用者进行了一项历史队列研究。我们比较了以下情况的发生率： (1) 临床编码痴呆和 (2) 使用 Cox 比例风险回归模型开出 VKA 和 DOAC 的患者之间的 MCI，以年龄为基础时间尺度，考虑日历时间和治疗时间、社会人口学和生活方式因素、临床合并症和药物。结果 39 200 名首次口服抗凝药使用者（44.6% 为女性，中位年龄 76 岁，IQR 68-83）中，20 687 名（53%）在基线时服用了 VKA，18 513 名（47%）服用了 DOAC。总体而言，1258 名患者 (3.2%) 患有全科医生记录的痴呆症，发病率为每 1000 人年 16.5 人。在整个队列中，与 VKA 治疗相比，DOAC 治疗 AF 可使痴呆诊断率降低 16%（调整后 HR 0.84，95% CI：0.73 至 0.98），并且与事件 MCI 降低 26%（调整后 HR 0.74，95） % CI：0.65 至 0.84）。各种敏感性分析的结果相似。结论 与开出 VKA 的患者相比，在新发 AF 开出 DOAC 的患者中，EHR 记录的痴呆和 MCI 事件较少见。本研究利用临床实践研究数据链的数据，该数据链是经英国药品和保健产品监管机构许可获得的。 这些数据由患者提供，并由 NHS 收集，作为其护理和支持的一部分。本研究中包含的解释和结论仅属于作者本人。本研究中使用的数据只能用于已提交并批准的 ISAC 方案中规定的目的。因此，研究小组无法存档任何数据。任何未来的研究都需要向 CPRD 提出新的申请，并直接从 CPRD 获得数据，并遵守其科学、数据治理和财务审批政策（参见 www.cprd.com）。