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体重对纳入ETNA-AF-Europe注册研究的房颤患者依度沙班治疗临床结局的影响。

Impact of Weight on Clinical Outcomes of Edoxaban Therapy in Atrial Fibrillation Patients Included in the ETNA-AF-Europe Registry.

作者信息

Boriani Giuseppe, De Caterina Raffaele, Manu Marius Constantin, Souza José, Pecen Ladislav, Kirchhof Paulus

机构信息

Cardiology Division, Department of Biomedical, Metabolic and Neural Sciences, University of Modena and Reggio Emilia, Policlinico di Modena, 41100 Modena, Italy.

Chair of Cardiology, Cardiology Division, Pisa University Hospital, University of Pisa, Via Paradisa 2, 56124 Pisa, Italy.

出版信息

J Clin Med. 2021 Jun 29;10(13):2879. doi: 10.3390/jcm10132879.

DOI:10.3390/jcm10132879
PMID:34209595
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8269173/
Abstract

BACKGROUND

Extremes of body weight may alter exposure to non-vitamin K antagonist oral anticoagulants and thereby impact clinical outcomes. This ETNA-AF-Europe sub-analysis assessed 1-year outcomes in routine care patients with atrial fibrillation across a range of body weight groups treated with edoxaban.

METHODS

ETNA-AF-Europe is a multinational, multicentre, observational study conducted in 825 sites in 10 European countries. Overall, 1310, 5565, 4346 and 1446 enrolled patients were categorised into ≤60 kg, >60-≤80 kg (reference weight group), >80-≤100 kg and >100 kg groups.

RESULTS

Patients weighing ≤60 kg were older, more frail and had a higher CHADS-VASc score vs. the other weight groups. The rates of stroke/systemic embolism, major bleeding and ICH were low at 1 year (0.82, 1.05 and 0.24%/year), with no significant differences among weight groups. The annualised event rates of all-cause death were 3.50%/year in the overall population. After adjustment for eGFR and CHADS-VASc score, the risk of all-cause death was significantly higher in extreme weight groups vs. the reference group.

CONCLUSIONS

Low rates of stroke and bleeding were reported with edoxaban, independent of weight. The risk of all-cause death was higher in extremes of weight vs. the reference group after adjustment for important risk modifiers, thus no obesity paradox was observed.

摘要

背景

体重 extremes 可能会改变非维生素 K 拮抗剂口服抗凝药的暴露量,从而影响临床结局。这项 ETNA-AF-欧洲亚组分析评估了接受依度沙班治疗的不同体重组房颤常规护理患者的 1 年结局。

方法

ETNA-AF-欧洲是一项在 10 个欧洲国家的 825 个地点进行的多国、多中心观察性研究。总体而言,1310 例、5565 例、4346 例和 1446 例入组患者被分为体重≤60 kg、>60-≤80 kg(参考体重组)、>80-≤100 kg 和>100 kg 组。

结果

与其他体重组相比,体重≤60 kg 的患者年龄更大、更虚弱且 CHADS-VASc 评分更高。1 年时卒中/全身性栓塞、大出血和颅内出血的发生率较低(分别为每年 0.82%、1.05%和 0.24%),体重组之间无显著差异。总体人群中全因死亡的年化发生率为每年 3.50%。在调整估算肾小球滤过率(eGFR)和 CHADS-VASc 评分后,极端体重组的全因死亡风险显著高于参考组。

结论

依度沙班治疗的卒中及出血发生率较低,与体重无关。在调整重要风险修正因素后,极端体重组的全因死亡风险高于参考组,因此未观察到肥胖悖论。

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本文引用的文献

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Europace. 2021 Oct 9;23(10):1676. doi: 10.1093/europace/euab157.
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Thromboembolic and Bleeding Risk in Atrial Fibrillation Patients with Chronic Kidney Disease: Role of Anticoagulation Therapy.慢性肾脏病心房颤动患者的血栓栓塞和出血风险:抗凝治疗的作用
J Clin Med. 2020 Dec 28;10(1):83. doi: 10.3390/jcm10010083.
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Mortality in Patients With Atrial Fibrillation Receiving Nonrecommended Doses of Direct Oral Anticoagulants.
直接口服抗凝剂在低体重房颤患者中的比较疗效和安全性:一项系统评价和荟萃分析
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Pharmacokinetics and Dosing Regimens of Direct Oral Anticoagulants in Morbidly Obese Patients: An Updated Literature Review.肥胖患者直接口服抗凝剂的药代动力学和给药方案:最新文献综述。
Clin Appl Thromb Hemost. 2023 Jan-Dec;29:10760296231153638. doi: 10.1177/10760296231153638.
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Int J Cardiol. 2020 Nov 1;318:67-73. doi: 10.1016/j.ijcard.2020.06.010. Epub 2020 Jun 21.