From the, Department of Emergency Medicine, Oregon Health & Science University School of Medicine, Portland, OR, USA.
and the, Department of Social and Behavioral Sciences, Harvard TS Chan School of Public Health, Boston, MA, USA.
Acad Emerg Med. 2021 Feb;28(2):226-239. doi: 10.1111/acem.14108. Epub 2020 Sep 20.
Clinical guidelines have supported outpatient treatment of low-risk pulmonary embolism (PE) since 2014, but adoption of this practice has been slow. Direct oral anticoagulant (DOAC) therapy for venous thromboembolism (VTE) is now as common as vitamin K antagonist treatment, but data are sparse regarding outcomes for patients with low-risk PE treated with DOACs as outpatients. We conducted a systematic review of literature on outcomes of outpatient management for PE, including comparisons to inpatient treatment and differences by anticoagulant class.
We searched Medline, Embase, PubMed, CENTRAL, clinicaltrials.gov, and ICTRN for studies published from January 1980 through February 2019 using a predefined strategy developed with a medical librarian. We included English-language randomized controlled trials (RCTs) and prospective nonrandomized trials (NRTs) of adult patients diagnosed with acute, symptomatic PE, and discharged from the emergency department or within 48 hours. Our primary outcome included four major adverse outcomes (all-cause mortality, PE-related mortality, recurrent VTE, and major bleeding) within 30 and 90 days. A preplanned subanalysis of high-quality studies assessed outcomes associated with different anticoagulation treatment classes.
Our initial search identified 6,818 records, of which 12 studies (four RCT, eight NRT) with a total of 3,191 patients were included in the review. All RCTs and six NRTs were determined to have low to moderate risk of bias and were classified as high quality. Outpatients in these studies (n = 1,814) had rates of 90-day major adverse outcomes below 1%, including all-cause mortality (0.7%, 95% confidence interval [CI] = 0.4% to 1.2%), PE-related mortality (0.06%, 95% CI = 0.01% to 0.3%), recurrent VTE (0.8%, 95% CI = 0.5% to 1.4%), and major bleeding (0.8%, 95% CI = 0.5% to 1.4%). Exploratory analysis revealed no association between anticoagulant treatment class and rates of major adverse outcomes.
Among patients with low-risk PE treated as outpatients, few patients experienced major adverse outcomes such as mortality, recurrent VTE, or major bleeding within 90 days.
自 2014 年以来，临床指南一直支持低危肺栓塞（PE）的门诊治疗，但这种治疗方法的采用一直较为缓慢。直接口服抗凝剂（DOAC）治疗静脉血栓栓塞症（VTE）现在与维生素 K 拮抗剂治疗一样常见，但关于使用 DOAC 作为门诊患者治疗低危 PE 的患者结局的数据却很少。我们对关于 PE 门诊管理结局的文献进行了系统回顾，包括与住院治疗的比较以及不同抗凝药物类别的差异。
我们使用一位医学图书管理员制定的预定义策略，在 Medline、Embase、PubMed、CENTRAL、clinicaltrials.gov 和 ICTRN 中搜索了 1980 年 1 月至 2019 年 2 月发表的英文随机对照试验（RCT）和前瞻性非随机试验（NRT）。我们纳入了在急诊科或 48 小时内出院的急性、有症状的 PE 成年患者的研究。我们的主要结局包括 30 天和 90 天内的四个主要不良结局（全因死亡率、PE 相关死亡率、复发性 VTE 和大出血）。一项针对高质量研究的预先计划的亚分析评估了不同抗凝治疗类别的相关结局。
我们最初的搜索确定了 6818 条记录，其中 12 项研究（4 项 RCT，8 项 NRT）共 3191 名患者纳入了综述。所有 RCT 和 6 项 NRT 被认为具有低到中度偏倚风险，被归类为高质量。这些研究中的门诊患者（n=1814）90 天主要不良结局的发生率低于 1%，包括全因死亡率（0.7%，95%置信区间[CI]0.4%至 1.2%）、PE 相关死亡率（0.06%，95%CI0.01%至 0.3%）、复发性 VTE（0.8%，95%CI0.5%至 1.4%）和大出血（0.8%，95%CI0.5%至 1.4%）。探索性分析显示，抗凝药物类别的选择与主要不良结局的发生率之间没有关联。
在接受门诊治疗的低危 PE 患者中，很少有患者在 90 天内出现死亡、复发性 VTE 或大出血等主要不良结局。
