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华法林与直接口服抗凝剂治疗需要远端深静脉血栓的患者。

Warfarin versus direct oral anticoagulants for patients needing distal deep vein thrombosis treatment.

机构信息

Department of Vascular and Endovascular Surgery, Albert Einstein College of Medicine and Montefiore Medical Center, Bronx, NY.

Department of Family, Community, and Preventive Medicine, Drexel University College of Medicine, Philadelphia, Pa.

出版信息

J Vasc Surg Venous Lymphat Disord. 2022 Jul;10(4):826-831.e1. doi: 10.1016/j.jvsv.2022.01.006. Epub 2022 Feb 3.

Abstract

OBJECTIVE

Great interest exists in standardizing the anticoagulant choice for patients requiring treatment of distal deep vein thrombosis (DDVT). In the present multicenter, retrospective cohort study, we evaluated the outcomes of patients with DDVT who had been treated with warfarin vs direct oral anticoagulants (DOACs; ie, rivaroxaban, apixaban, edoxaban, dabigatran).

METHODS

Queries were built for the TriNetX database (TriNetX LLC, Cambridge, Mass), a federated network of healthcare organizations across the United States that provides de-identified patient data through aggregated counts and statistical summaries. International Classification of Diseases, 10th revision, diagnostic codes were used to identify eligible patients. Data from January 1, 2013 to January 1, 2020 were reviewed. Statistical analyses, including propensity matching, were performed using TriNetX's internal software. The inclusion criterion was treatment with either warfarin or a DOAC started within the first 24 hours of diagnosis of an isolated thrombosis of the following veins: anterior tibial, posterior tibial, peroneal, or calf muscular veins. The exclusion criteria were a history of an adverse reaction to anticoagulant agents, SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) infection, thrombophilia, mechanical heart valve, chronic proximal DVT (PDVT) and/or DDVT, and 6-month history of the following: acute PDVT, pulmonary embolism (PE), or anticoagulant usage. The outcomes measured included the incidence of mortality, PE, PDVT, stroke, myocardial infarction, and major bleeding within 6 months after initiating anticoagulation therapy.

RESULTS

In a cohort of 6509 patients, 1570 were treated with warfarin and 4939 were treated with a DOAC drug. After propensity matching for age, sex, ethnicity, and comorbidities, the DOAC cohort had a significantly lower incidence of PE (1.795% vs 3.590%; P = .0020) and major bleeding (7.949% vs 10.513%; P = .0134). Differences in the incidence of mortality, PDVT, myocardial infarction, and stroke were not statistically significant.

CONCLUSIONS

Before the present study, no strong evidence was available to suggest an optimal treatment modality for DDVT requiring anticoagulation therapy. The data from the present study suggest that patients receiving DOACs for the treatment of DDVT will have significantly lower rates of progression to PE and a lower incidence of major bleeding compared with patients receiving warfarin. This suggests that DOACs are superior to warfarin for treatment of DDVT.

摘要

目的

对于需要治疗远端深静脉血栓(DDVT)的患者,选择抗凝剂的标准化具有重要意义。在本多中心回顾性队列研究中,我们评估了接受华法林与直接口服抗凝剂(DOAC;即利伐沙班、阿哌沙班、依度沙班、达比加群)治疗的 DDVT 患者的结局。

方法

为 TriNetX 数据库(TriNetX LLC,马萨诸塞州剑桥)构建了查询,TriNetX 是一个由美国各地医疗保健组织组成的联邦网络,通过汇总计数和统计摘要提供去识别患者数据。使用国际疾病分类第 10 版诊断代码来识别符合条件的患者。审查了 2013 年 1 月 1 日至 2020 年 1 月 1 日的数据。使用 TriNetX 的内部软件进行了包括倾向评分匹配在内的统计分析。纳入标准为在孤立性血栓形成的前胫骨、后胫骨、腓骨或小腿肌静脉的诊断后 24 小时内开始使用华法林或 DOAC 进行治疗。排除标准为抗凝剂治疗有不良反应史、SARS-CoV-2(严重急性呼吸综合征冠状病毒 2)感染、血栓形成倾向、机械心脏瓣膜、慢性近端深静脉血栓形成(PDVT)和/或 DDVT,且在过去 6 个月内有以下病史:急性 PDVT、肺栓塞(PE)或抗凝治疗。测量的结局包括开始抗凝治疗后 6 个月内的死亡率、PE、PDVT、卒中和心肌梗死及大出血的发生率。

结果

在 6509 例患者中,1570 例接受华法林治疗,4939 例接受 DOAC 药物治疗。在年龄、性别、种族和合并症进行倾向评分匹配后,DOAC 组的 PE(1.795%比 3.590%;P=.0020)和大出血(7.949%比 10.513%;P=.0134)发生率显著较低。死亡率、PDVT、心肌梗死和卒中等结局发生率的差异无统计学意义。

结论

在本研究之前,尚无强有力的证据表明 DDVT 需要抗凝治疗时哪种治疗方式是最佳的。本研究的数据表明,与接受华法林治疗的患者相比,接受 DOAC 治疗的 DDVT 患者的 PE 进展率和大出血发生率显著降低。这表明 DOAC 优于华法林治疗 DDVT。

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