Outpatient versus inpatient treatment for patients with acute pulmonary embolism: an international, open-label, randomised, non-inferiority trial
Outpatient versus inpatient treatment for patients with acute pulmonary embolism: an international, open-label, randomised, non-inferiority trial
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DOI：
10.1016/s0140-6736(11)60824-6
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发表时间：
2011-07-02
期刊：
影响因子：
168.9
通讯作者：
Yealy, Donald M.
中科院分区：
文献类型：
--
作者：
Aujesky, Drahomir;Roy, Pierre-Marie;Yealy, Donald M.
背景 尽管实践指南建议对选定的血流动力学稳定的肺栓塞患者进行门诊治疗，但目前大多数治疗都是住院治疗。我们的目的是评估门诊护理与住院护理相比的非劣效性。方法我们在瑞士、法国、比利时和美国的 19 个急诊科进行了一项开放标签、随机非劣效性试验。我们按照计算机生成的随机序列（2-4 组）按 1:1 的比例将患有急性症状性肺栓塞且死亡风险较低（肺栓塞严重指数风险等级 I 或 II）的患者与初始门诊患者（即出院 = 5 天）随机分配，然后接受口服抗凝治疗（≥ 90 天）。主要结局是 90 天内有症状、复发性静脉血栓栓塞；安全性结果包括 14 或 90 天内的大出血和 90 天内的死亡。我们使用 4% 的非劣效界值来衡量住院患者组和门诊患者组之间的差异。我们将所有入组患者纳入主要分析，不包括失访患者。该试验已在 ClinicalTrials.gov 注册，编号为 NCT00425542。调查结果 2007 年 2 月至 2010 年 6 月期间，我们招募了 344 名符合条件的患者。在初步分析中，171 名门诊患者中有 1 名 (0.6%) 在 90 天内出现复发性静脉血栓栓塞，而 168 名住院患者则没有出现复发性静脉血栓栓塞（95% 置信上限 [UCL] 2-7%；p=0.011）。每个治疗组中只有 1 名患者 (0.6%) 在 90 天内死亡 (95% UCL 2.1%; p=0.005)，171 名门诊患者中有 2 名 (1.2%) 在 14 天内出现大出血，没有住院患者 (95% UCL 3.6%; p=0.031)。到 90 天时，三名 (1.8%) 门诊患者出现大出血，但没有住院患者出现大出血 (95% UCL 4.5%；p=0.086)。门诊患者的平均住院时间为 0.5 天 (SD 1.0)，住院患者的平均住院时间为 3.9 天 (SD 3.1)。 解释 对于选定的低风险肺栓塞患者，可以安全有效地使用门诊护理代替住院护理。
Background Although practice guidelines recommend outpatient care for selected, haemodynamically stable patients with pulmonary embolism, most treatment is presently inpatient based. We aimed to assess non-inferiority of outpatient care compared with inpatient care.Methods We undertook an open-label, randomised non-inferiority trial at 19 emergency departments in Switzerland, France, Belgium, and the USA. We randomly assigned patients with acute, symptomatic pulmonary embolism and a low risk of death (pulmonary embolism severity index risk classes I or II) with a computer-generated randomisation sequence (blocks of 2-4) in a 1:1 ratio to initial outpatient (ie, discharged from hospital = 5 days) followed by oral anticoagulation (>= 90 days). The primary outcome was symptomatic, recurrent venous thromboembolism within 90 days; safety outcomes included major bleeding within 14 or 90 days and mortality within 90 days. We used a non-inferiority margin of 4% for a difference between inpatient and outpatient groups. We included all enrolled patients in the primary analysis, excluding those lost to follow-up. This trial is registered with ClinicalTrials.gov, number NCT00425542.Findings Between February, 2007, and June, 2010, we enrolled 344 eligible patients. In the primary analysis, one (0.6%) of 171 outpatients developed recurrent venous thromboembolism within 90 days compared with none of 168 inpatients (95% upper confidence limit [UCL] 2-7%; p=0.011). Only one (0.6%) patient in each treatment group died within 90 days (95% UCL 2.1%; p=0.005), and two (1.2%) of 171 outpatients and no inpatients had major bleeding within 14 days (95% UCL 3.6%; p=0.031). By 90 days, three (1.8%) outpatients but no inpatients had developed major bleeding (95% UCL 4.5%; p=0.086). Mean length of stay was 0.5 days (SD 1.0) for outpatients and 3.9 days (SD 3.1) for inpatients.Interpretation In selected low-risk patients with pulmonary embolism, outpatient care can safely and effectively be used in place of inpatient care.