Background

Direct oral anticoagulants (DOACs) have become favorable choices for anticoagulation due to their fixed-dose schedule, limited need for monitoring, and non-inferiority or superiority to warfarin. DOACs are currently not recommended in patients with a body weight ≥ 120 kg or body mass index ≥ 40 kg/m² due to limited data regarding safety and efficacy.

Objective

The aim of this study was to compare the safety and efficacy of DOACs in patients with nonvalvular atrial fibrillation (NVAF) and weighing ≥ 120 kg with those weighing < 120 kg.

Methods

A single-center, retrospective study was conducted in patients weighing ≥ 120 kg who received either apixaban, dabigatran, or rivaroxaban for stroke risk reduction in NVAF, and matched to patients who weighed < 120 kg. The primary outcome was the incidence of stroke, deep vein thrombosis, pulmonary embolism, or myocardial infarction, while the safety outcome was the incidence of major or clinically relevant non-major bleeding based on the International Society on Thrombosis and Haemostasis (ISTH) definitions.

Results

A total of 318 patients weighing ≥ 120 kg with NVAF and meeting the inclusion criteria were evaluated and matched with 318 patients weighing < 120 kg. The primary outcome occurred in 2.5% of patients in the ≥ 120 kg group and in 3.1% of patients in the < 120 kg group (p = 0.632). The safety outcome occurred in 5.3% and 6.6% of patients in these respective groups (p = 0.503).

Conclusion

Apixaban, dabigatran, or rivaroxaban may be well-tolerated and effective anticoagulant options in patients with NVAF weighing ≥ 120 kg.

中文翻译：

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非瓣膜性房颤和体重 ≥ 120 公斤与 60–120 公斤患者直接口服抗凝剂的有效性和安全性

背景

直接口服抗凝剂 (DOAC) 由于其固定剂量方案、有限的监测需求以及不劣于或优于华法林，已成为抗凝的有利选择。由于有关安全性和有效性的数据有限，目前不建议体重 ≥ 120 kg 或体重指数 ≥ 40 kg/m ^{2 的}患者使用 DOAC 。

客观的

本研究的目的是比较 DOAC 对体重 ≥ 120 kg 和体重 < 120 kg 的非瓣膜性心房颤动 (NVAF) 患者的安全性和有效性。

方法

一项单中心、回顾性研究在体重 ≥ 120 kg 的患者中进行，这些患者接受了阿哌沙班、达比加群或利伐沙班以降低 NVAF 的卒中风险，并与体重 < 120 kg 的患者相匹配。主要结果是中风、深静脉血栓形成、肺栓塞或心肌梗塞的发生率，而安全性结果是基于国际血栓形成和止血学会 (ISTH) 定义的大出血或临床相关非大出血的发生率。

结果

共有 318 名体重 ≥ 120 kg 且符合纳入标准的 NVAF 患者进行了评估，并与 318 名体重 < 120 kg 的患者相匹配。≥ 120 kg 组中 2.5% 的患者和 < 120 kg 组中 3.1% 的患者出现主要结局 ( p  = 0.632)。在这些各自的组中，安全性结果发生在 5.3% 和 6.6% 的患者中 ( p  = 0.503)。

结论

对于体重 ≥ 120 kg 的 NVAF 患者，阿哌沙班、达比加群或利伐沙班可能是耐受性良好且有效的抗凝剂选择。