Bern University Hospital, Switzerland.
Lancet. 2011 Jul 2;378(9785):41-8. doi: 10.1016/S0140-6736(11)60824-6. Epub 2011 Jun 22.
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.
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 ≤24 h after randomisation) or inpatient treatment with subcutaneous enoxaparin (≥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.
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.
In selected low-risk patients with pulmonary embolism, outpatient care can safely and effectively be used in place of inpatient care.
Swiss National Science Foundation, Programme Hospitalier de Recherche Clinique, and the US National Heart, Lung, and Blood Institute. Sanofi-Aventis provided free drug supply in the participating European centres.
尽管临床实践指南推荐对特定的、血流动力学稳定的肺栓塞患者进行门诊治疗，但目前大多数治疗仍为住院治疗。我们旨在评估门诊治疗与住院治疗相比是否不劣效。
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。我们将具有急性、有症状的肺栓塞和低死亡风险（肺栓塞严重指数风险类别 I 或 II）的患者随机分配，使用计算机生成的随机序列（2-4 个块）以 1:1 的比例分为初始门诊（即随机分组后 24 小时内出院）或住院治疗，皮下给予依诺肝素（≥5 天），然后口服抗凝治疗（≥90 天）。主要结局是 90 天内有症状的、复发性静脉血栓栓塞；安全性结局包括 14 天或 90 天内大出血和 90 天内死亡率。我们使用 4%的差异作为门诊和住院组之间的非劣效性边界。我们将所有入组患者纳入主要分析，不包括失访患者。该试验在 ClinicalTrials.gov 注册，编号为 NCT00425542。
在 2007 年 2 月至 2010 年 6 月期间，我们纳入了 344 名符合条件的患者。在主要分析中，171 名门诊患者中有 1 名（0.6%）在 90 天内发生复发性静脉血栓栓塞，而 168 名住院患者无一例发生（95%置信上限[UCL]2.7%；p=0.011）。两组中只有 1 名（0.6%）患者在 90 天内死亡（95%UCL 2.1%；p=0.005），171 名门诊患者中有 2 名（1.2%）和无住院患者在 14 天内发生大出血（95%UCL 3.6%；p=0.031）。90 天时，3 名（1.8%）门诊患者而非住院患者发生大出血（95%UCL 4.5%；p=0.086）。门诊患者的平均住院时间为 0.5 天（标准差 1.0），住院患者为 3.9 天（标准差 3.1）。
在选择的低风险肺栓塞患者中，门诊治疗可安全有效地替代住院治疗。
瑞士国家科学基金会、医院临床研究计划和美国国家心脏、肺和血液研究所。赛诺菲安万特提供了参与欧洲中心的免费药物供应。
