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≥80岁心房颤动患者使用美国食品药品监督管理局(FDA)批准的减量或全量直接口服抗凝剂的回顾性比较

Retrospective Comparison of Patients ≥ 80 Years With Atrial Fibrillation Prescribed Either an FDA-Approved Reduced or Full Dose Direct-Acting Oral Anticoagulant.

作者信息

Taoutel Roy, Ezekowitz Michael D, Chaudhry Usman A, Weber Carly, Hassan Dana, Gracely Ed J, Kamareddine Mohammed H, Horn Benjamin I, Harper Glenn R

机构信息

Lankenau Medical Center Main Line Health, Wynnewood, PA, USA.

Bryn Mawr Hospital Main Line Health, Bryn Mawr, PA, USA.

出版信息

Int J Cardiol Heart Vasc. 2022 Oct 10;43:101130. doi: 10.1016/j.ijcha.2022.101130. eCollection 2022 Dec.

DOI:10.1016/j.ijcha.2022.101130
PMID:36246771
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9556913/
Abstract

Direct-acting oral anticoagulants (DOACs) represent the standard for preventing stroke and systemic embolization (SSE) in patients with atrial fibrillation (AF). There is limited information for patients ≥ 80 years. We report a retrospective analysis of AF patients ≥ 80 years prescribed either a US Food and Drug Administration (FDA)-approved reduced (n = 514) or full dose (n = 199) DOAC (Dabigatran, Rivaroxaban, or Apixaban) between January 1st, 2011 (first DOAC commercially available) and May 31st, 2017. The following multivariable differences in baseline characteristics were identified: patients prescribed a reduced dose DOAC were older (p < 0.001), had worse renal function (p = 0.001), were more often prescribed aspirin (p = 0.004) or aspirin and clopidogrel (p < 0.001), and more often had new-onset AF (p = 0.001). SSE and central nervous system (CNS) bleed rates were low and not different (1.02 vs 0 %/yr and 1.45 vs 0.44 %/yr) for the reduced and full dose groups, respectively. For non-CNS bleeds, rates were 10.89 vs 4.15 %/yr (p < 0.001, univariable) for the reduced and full doses, respectively. The mortality rate was 6.24 vs 1.75 %/yr (p = 0.001, univariable) for the reduced and full doses. Unlike the non-CNS bleed rate, mortality rate differences remained significant when adjusted for baseline characteristics. Thus, DOACs in patients ≥ 80 with AF effectively reduce SSE with a low risk of CNS bleeding, independent of DOAC dose. The higher non-CNS bleed rate and not the mortality rate is explained by the higher risk baseline characteristics in the reduced DOAC dose group. Further investigation of the etiology of non-CNS bleeds and mortality is warranted.

摘要

直接口服抗凝剂(DOACs)是预防心房颤动(AF)患者中风和全身性栓塞(SSE)的标准治疗方法。关于80岁及以上患者的信息有限。我们报告了一项对2011年1月1日(首个DOAC上市)至2017年5月31日期间,年龄≥80岁且处方了美国食品药品监督管理局(FDA)批准的低剂量(n = 514)或全剂量(n = 199)DOAC(达比加群、利伐沙班或阿哌沙班)的AF患者的回顾性分析。确定了基线特征的以下多变量差异:处方低剂量DOAC的患者年龄更大(p < 0.001),肾功能更差(p = 0.001),更常处方阿司匹林(p = 0.004)或阿司匹林和氯吡格雷(p < 0.001),且新发AF的情况更常见(p = 0.001)。低剂量组和全剂量组的SSE和中枢神经系统(CNS)出血率较低且无差异(分别为1.02 vs 0%/年和1.45 vs 0.44%/年)。对于非CNS出血,低剂量组和全剂量组的发生率分别为10.89 vs 4.15%/年(p < 0.001,单变量)。死亡率分别为6.24 vs 1.75%/年(p = 0.001,单变量)。与非CNS出血率不同,调整基线特征后死亡率差异仍显著。因此,对于≥80岁的AF患者,DOACs可有效降低SSE,且CNS出血风险较低,与DOAC剂量无关。低剂量DOAC组较高的非CNS出血率而非死亡率是由更高风险的基线特征所解释。有必要进一步研究非CNS出血和死亡率的病因。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9bb9/9556913/5c4d996f3cea/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9bb9/9556913/acd8c70af627/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9bb9/9556913/5c4d996f3cea/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9bb9/9556913/acd8c70af627/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9bb9/9556913/5c4d996f3cea/gr2.jpg

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