Department of Medicine (A.C.P., K.P., M.P.T.) and Center for Digital Health (A.C.P., N.D., M.P.T.), Stanford University School of Medicine, CA.
Veterans Affairs Palo Alto Health Care System, CA (A.C.P., J.F., S.S., N.D., M.K., M.P.T.).
Circ Cardiovasc Qual Outcomes. 2021 Nov;14(11):e008005. doi: 10.1161/CIRCOUTCOMES.121.008005. Epub 2021 Nov 2.
Consensus statements have recommended against the use of direct oral anticoagulants (DOACs) in venous thromboembolism (VTE) for patients ≥120 kg and ≥40 kg/m. We sought to determine use and outcomes of DOACs for VTE across weight and body mass index (BMI).
We performed a retrospective cohort study of patients with first-time VTE 2013 to 2018 that were treated with DOAC or warfarin in the Veterans Health Administration. The Veterans Health Administration has implemented system-wide guidance for patient selection and shared decision-making for use of DOACs in VTE at extremes of weight. We stratified patients by weight and BMI and assessed (1) association of weight and BMI category to outcomes in those prescribed DOAC; and (2) association of DOAC, as compared to warfarin, to outcomes by weight and BMI categories. Outcomes of interest included major bleeding, clinically relevant nonmajor bleeding, and recurrent VTE.
The analysis cohort included 51 871 patients prescribed DOAC or warfarin within 30 days of index VTE diagnosis (age 64.5±13.1 years; 6.0% female; median weight 93.4 kg [25th-75th: 80.5-108.6 kg]). For patients ≥120 kg (N=6934 patients), 38.4% were treated with DOAC, as compared to 45.4% of those ≥60 to <100 kg (N=30 645; <0.0001). DOAC prescription was not associated with major bleeds, clinically relevant nonmajor bleeds, or recurrent VTE for those in higher weight and BMI categories as compared to those in average weight and BMI categories. DOAC prescription, as compared to warfarin, was not associated with increased recurrent VTE in any weight or BMI category.
Patients ≥120 kg and ≥40 kg/m with VTE are frequently prescribed DOAC by the Veterans Health Administration, without an increase in bleeding or recurrent VTE. These findings suggest DOACs can be safe and effective in this population and may argue for broader adoption of pharmacy policies that promote careful patient selection and shared decision making.
共识声明建议对体重≥120kg 和体重指数（BMI）≥40kg/m²的静脉血栓栓塞（VTE）患者避免使用直接口服抗凝剂（DOAC）。我们旨在确定 DOAC 在各种体重和 BMI 范围内用于 VTE 的使用情况和结局。
我们对 2013 年至 2018 年期间在退伍军人健康管理局接受 DOAC 或华法林治疗的首次 VTE 患者进行了回顾性队列研究。退伍军人健康管理局已经在体重极端值的 VTE 治疗中实施了针对 DOAC 患者选择和共同决策的系统范围指导。我们按体重和 BMI 分层患者，并评估了（1）在接受 DOAC 治疗的患者中，体重和 BMI 类别与结局的相关性；以及（2）与华法林相比，DOAC 与体重和 BMI 类别的结局的相关性。感兴趣的结局包括大出血、临床相关非大出血和复发性 VTE。
分析队列包括 51871 名在 VTE 诊断后 30 天内接受 DOAC 或华法林治疗的患者（年龄 64.5±13.1 岁；6.0%为女性；中位数体重为 93.4kg[25 至 75 百分位：80.5-108.6kg]）。对于体重≥120kg（n=6934 例）的患者，38.4%接受了 DOAC 治疗，而体重≥60 至<100kg（n=30645 例）的患者中，接受 DOAC 治疗的比例为 45.4%（<0.0001）。与平均体重和 BMI 类别相比，较高体重和 BMI 类别的患者接受 DOAC 治疗与大出血、临床相关非大出血或复发性 VTE 无关。与华法林相比，DOAC 治疗与任何体重或 BMI 类别中复发性 VTE 的增加无关。
退伍军人健康管理局经常为体重≥120kg 和 BMI≥40kg/m²的 VTE 患者开 DOAC 处方，不会增加出血或复发性 VTE 的风险。这些发现表明 DOAC 在该人群中可以安全有效，并且可能支持更广泛地采用促进患者精心选择和共同决策的药房政策。
