Abstract

Background

Direct oral anticoagulants (DOACs) are the preferred treatment for venous thromboembolism (VTE). However, DOAC use in patients with a BMI greater than 40 kg/m² has not been well studied despite the growing prevalence of obesity, and current literature is often underpowered.

Methods

This multicenter, retrospective, observational study evaluated patients 18 years and older who received DOACs for acute VTE treatment. Patients receiving DOACs for recurrent VTE or for failure of another agent were excluded. The primary efficacy outcome was recurrent VTE and the primary safety outcome was major bleeding within 12 months (or one month after stopping anticoagulation therapy). A propensity score analysis was performed to balance patient characteristics and evaluate the primary endpoints by BMI group. Time-to-event outcomes were analyzed using weighted Kaplan-Meier curves.

Results

There were 165 patients with a BMI of at least 40 kg/m² and 320 patients with a BMI less than 40 kg/m². The majority received apixaban (373, 77%). Recurrent VTE occurred in 5 (3.0%) and 13 (4.1%) of patients in the higher and lower BMI groups, respectively (adjusted OR: 0.66; 95% CI: 0.16–2.69). Major bleeding occurred in 5 (3.0%) and 15 (4.7%) of patients in the higher and lower BMI groups, respectively (adjusted OR: 1.19; 95% CI: 0.36–3.92).

Conclusion

There was no significant difference in VTE recurrence or major bleeding related to BMI among patients treated with DOACs. This study showed that DOACs may be a safe and effective VTE treatment option in patients with obesity.

中文翻译：

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直接口服抗凝药治疗肥胖症静脉血栓栓塞的安全性和有效性的回顾性、多中心分析

摘要

背景

直接口服抗凝剂（DOAC）是静脉血栓栓塞（VTE）的首选治疗方法。然而，尽管肥胖患病率不断上升，但 DOAC 在 BMI 大于 40 kg/m ²的患者中的使用尚未得到充分研究，并且当前文献往往缺乏说服力。

方法

这项多中心、回顾性、观察性研究评估了接受 DOAC 治疗急性 VTE 的 18 岁及以上患者。因静脉血栓栓塞复发或其他药物治疗失败而接受 DOAC 的患者被排除在外。主要疗效结局是复发性 VTE，主要安全性结局是 12 个月内（​​或停止抗凝治疗后 1 个月）内大出血。进行倾向评分分析以平衡患者特征并按 BMI 组评估主要终点。使用加权卡普兰-迈耶曲线分析事件发生时间结果。

结果

^{BMI 至少为 40 kg/m 2}的患者有 165 名，BMI 低于 40 kg/m ²的患者有 320 名。大多数人接受阿哌沙班治疗（373 人，77%）。BMI 较高组和较低 BMI 组中分别有 5 名 (3.0%) 和 13 名 (4.1%) 患者出现复发性 VTE（调整后 OR：0.66；95% CI：0.16-2.69）。BMI 较高组和较低 BMI 组中分别有 5 名 (3.0%) 和 15 名 (4.7%) 患者发生大出血（调整后 OR：1.19；95% CI：0.36-3.92）。

结论

在接受 DOAC 治疗的患者中，与 BMI 相关的 VTE 复发或大出血没有显着差异。这项研究表明，DOAC 可能是肥胖患者安全有效的 VTE 治疗选择。