达比加群酯在重度肥胖的房颤患者中的有效性和安全性：一项真实世界回顾性队列研究。
Effectiveness and Safety of Dabigatran in Atrial Fibrillation Patients with Severe Obesity: a Real-World Retrospective Cohort Study.
机构信息
Department of Hospital Medicine, Kaiser Permanente Los Angeles Medical Center, Los Angeles, CA, USA.
Department of Research & Evaluation, Kaiser Permanente Southern California, Pasadena, CA, USA.
出版信息
J Gen Intern Med. 2022 Sep;37(12):2982-2990. doi: 10.1007/s11606-021-07114-8. Epub 2021 Sep 20.
BACKGROUND
Direct oral anticoagulants such as dabigatran are the preferred anticoagulant in treating atrial fibrillation (AF) patients due to their effectiveness and safety. Whether this applies to severely obese patients needs to be determined.
OBJECTIVE
To compare the effectiveness and safety of dabigatran with warfarin among AF patients with severe obesity.
DESIGN
Retrospective cohort study.
PARTICIPANTS
AF patients with a BMI >40kg/m or a weight >120kg receiving dabigatran or warfarin between 10/01/2010 and 12/31/2019 in a large integrated health system and followed through 08/01/2020.
INTERVENTIONS
Not applicable.
MAIN MEASURES
Primary effectiveness outcome was composite thromboembolism including transient ischemic attack, ischemic stroke, or systemic embolism. Primary safety outcome was composite bleeding including gastrointestinal bleeding, intracranial bleeding, or other bleeding. Secondary outcomes included the individual outcomes and all-cause mortality. Propensity score matching (PSM) was performed to create a 1:1 matched cohort and Cox proportional hazards model was used to estimate the hazard ratio (HR) of each outcome for dabigatran users compared to warfarin users.
KEY RESULTS
A total of 6848 patients receiving either dabigatran or warfarin were identified. In a 1:1 matched cohort, dabigatran users had a HR of 0.71 (95% confidence interval (CI): 0.56-0.91) for composite thromboembolism, a HR of 1.24 (95%CI: 1.07-1.42) for composite bleeding, and a HR of 0.57 (95% CI: 0.45-0.71) for all-cause mortality when compared to warfarin users.
CONCLUSIONS
Among AF patients with a BMI >40kg/m or a weight >120kg in a real-world clinical setting, dabigatran was effective in reducing the risk of thromboembolism and mortality but was associated with an increased risk of bleeding when compared to warfarin. Dabigatran may be a reasonable option for AF patients with severe obesity.
背景
达比加群等直接口服抗凝剂因其有效性和安全性，成为治疗心房颤动（AF）患者的首选抗凝剂。但这是否适用于重度肥胖患者仍需确定。
目的
比较达比加群与华法林在重度肥胖 AF 患者中的疗效和安全性。
设计
回顾性队列研究。
参与者
2010 年 10 月 1 日至 2019 年 12 月 31 日期间，在一个大型综合医疗系统中接受达比加群或华法林治疗的 BMI＞40kg/m2 或体重＞120kg 的 AF 患者，并随访至 2020 年 8 月 1 日。
干预措施
无。
主要观察指标
主要有效性结局为包括短暂性脑缺血发作、缺血性卒中和全身性栓塞在内的复合血栓栓塞事件。主要安全性结局为包括胃肠道出血、颅内出血和其他出血在内的复合出血事件。次要结局包括各单项结局和全因死亡率。采用倾向评分匹配（PSM）创建 1:1 匹配队列，并采用 Cox 比例风险模型估计与华法林相比，达比加群使用者每种结局的风险比（HR）。
主要结果
共纳入 6848 例接受达比加群或华法林治疗的患者。在 1:1 匹配队列中，与华法林相比，达比加群使用者的复合血栓栓塞事件 HR 为 0.71（95%置信区间（CI）：0.560.91），复合出血事件 HR 为 1.24（95%CI：1.071.42），全因死亡率 HR 为 0.57（95%CI：0.45~0.71）。
结论
在真实临床环境中 BMI＞40kg/m2 或体重＞120kg 的 AF 患者中，与华法林相比，达比加群可有效降低血栓栓塞和死亡率风险，但出血风险增加。对于重度肥胖的 AF 患者，达比加群可能是一种合理的选择。
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