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利用“真实世界”密歇根抗凝质量改进计划(MAQI)注册中心比较肥胖人群中 DOAC 和华法林的结果。

Comparing DOAC and warfarin outcomes in an obese population using the 'real-world' Michigan Anticoagulation Quality Improvement Initiative (MAQI) registry.

机构信息

Department of Internal Medicine, University of Michigan, Ann Arbor, MI, USA.

Current: Department of Cardiology, Rush University Medical Center, Chicago, IL, USA.

出版信息

Vasc Med. 2024 Oct;29(5):543-552. doi: 10.1177/1358863X241264478. Epub 2024 Aug 23.

Abstract

INTRODUCTION

Direct oral anticoagulants (DOACs) have overtaken warfarin in the treatment of nonvalvular atrial fibrillation (AF) and venous thromboembolism (VTE). Limited data explore the safety of DOACs in obesity.

METHODS

This multicenter retrospective study between June 2015 and September 2019 uses the Michigan Anticoagulation Quality Improvement Initiative (MAQI) registry to compare DOACs and warfarin across weight classes (not obese: body mass index (BMI) ⩾ 18.5 and < 30; obese: BMI ⩾ 30 and < 40; severely obese: BMI ⩾ 40). Primary outcomes include major, clinically relevant nonmajor (CRNM), and minor bleeding events per 100 patient-years. Secondary outcomes include stroke, recurrent VTE, and all-cause mortality.

RESULTS

DOACs were prescribed to 49% of the 4089 patients with AF and 46% of the 3162 patients with VTE. Compared to patients treated with warfarin, those treated with DOACs had a higher estimated glomerular filtration rate across BMI categories regardless of indication. In the AF population, severely obese patients treated with DOACs had more major (3.4 vs 1.8, = 0.004), CRNM (8.6 vs 5.9, = 0.019), and minor bleeding (11.4 vs 9.9, = 0.001). There was no difference in stroke or all-cause mortality. In the VTE population, both CRNM (7.5 vs 6.7, = 0.042) and minor bleeding (19.3 vs 10.5, < 0.001) events occurred at higher rates in patients treated with DOACs. There was no difference in recurrent pulmonary embolism, stroke, or all-cause mortality.

CONCLUSION

There is a higher rate of bleeding in severely obese patients with VTE and AF treated with DOACs compared to warfarin, without a difference in secondary outcomes. Further studies to compare the anticoagulant classes and understand bleeding drivers in this population are needed.

摘要

介绍

直接口服抗凝剂(DOACs)在非瓣膜性心房颤动(AF)和静脉血栓栓塞(VTE)的治疗中已超过华法林。有限的数据探讨了肥胖患者使用 DOACs 的安全性。

方法

本研究为 2015 年 6 月至 2019 年 9 月间进行的一项多中心回顾性研究,使用密歇根州抗凝质量改进倡议(MAQI)登记处比较了体重类别(非肥胖:体重指数(BMI)≥18.5 且<30;肥胖:BMI≥30 且<40;重度肥胖:BMI≥40)中 DOACs 和华法林的使用情况。主要结局包括每 100 患者年的主要、临床相关非主要(CRNM)和次要出血事件。次要结局包括卒中、复发性 VTE 和全因死亡率。

结果

在 4089 例 AF 患者和 3162 例 VTE 患者中,49%和 46%分别接受了 DOACs 治疗。与接受华法林治疗的患者相比,无论适应证如何,接受 DOACs 治疗的患者在所有 BMI 类别中均具有更高的估计肾小球滤过率。在 AF 人群中,接受 DOACs 治疗的重度肥胖患者的主要出血(3.4 比 1.8,=0.004)、CRNM(8.6 比 5.9,=0.019)和次要出血(11.4 比 9.9,=0.001)更多。卒中或全因死亡率无差异。在 VTE 人群中,接受 DOACs 治疗的患者 CRNM(7.5 比 6.7,=0.042)和次要出血(19.3 比 10.5,<0.001)事件的发生率更高。复发性肺栓塞、卒中或全因死亡率无差异。

结论

与华法林相比,接受 DOACs 治疗的 VTE 和 AF 重度肥胖患者的出血发生率更高,但次要结局无差异。需要进一步的研究来比较这两种抗凝药物类别,并了解该人群的出血驱动因素。

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