Barco Stefano, Lankeit Mareike, Binder Harald, Schellong Sebastian, Christ Michael, Beyer-Westendorf Jan, Duerschmied Daniel, Bauersachs Rupert, Empen Klaus, Held Matthias, Schwaiblmair Martin, Fonseca Cândida, Jiménez David, Becattini Cecilia, Quitzau Kurt, Konstantinides Stavros
Stavros V. Konstantinides, MD, FESC, Center for Thrombosis and Hemostasis, University Medical Center Mainz, Langenbeckstrasse 1, Building 403, 55131 Mainz, Germany, Tel.: +49 6131 17 8382, Fax: +49 6131 17 3456, E-mail:
Thromb Haemost. 2016 Jul 4;116(1):191-7. doi: 10.1160/TH16-01-0004. Epub 2016 Mar 24.
Pulmonary embolism (PE) is a potentially life-threatening acute cardiovascular syndrome. However, more than 95 % of patients are haemodynamically stable at presentation, and among them are patients at truly low risk who may qualify for immediate or early discharge. The Home Treatment of Pulmonary Embolism (HoT-PE) study is a prospective international multicentre single-arm phase 4 management (cohort) trial aiming to determine whether home treatment of acute low-risk PE with the oral factor Xa inhibitor rivaroxaban is feasible, effective, and safe. Patients with confirmed PE, who have no right ventricular dysfunction or free floating thrombi in the right atrium or ventricle, are eligible if they meet none of the exclusion criteria indicating haemodynamic instability, serious comorbidity or any condition mandating hospitalisation, or a familial/social environment unable to support home treatment. The first dose of rivaroxaban is given in hospital, and patients are discharged within 48 hours of presentation. Rivaroxaban is taken for at least three months. The primary outcome is symptomatic recurrent venous thromboembolism or PE-related death within three months of enrolment. Secondary outcomes include quality of life and patient satisfaction, and health care resource utilisation compared to existing data on standard-duration hospital treatment. HoT-PE is planned to analyse 1,050 enrolled patients, providing 80 % power to reject the null hypothesis that the recurrence rate of venous thromboembolism is >3 % with α≤0.05. If the hypothesis of HoT-PE is confirmed, early discharge and out-of-hospital treatment may become an attractive, potentially cost-saving option for a significant proportion of patients with acute PE.
肺栓塞（PE）是一种潜在的危及生命的急性心血管综合征。然而，超过95%的患者在就诊时血流动力学稳定，其中包括真正低风险的患者，这些患者可能符合立即或早期出院的条件。肺栓塞家庭治疗（HoT-PE）研究是一项前瞻性国际多中心单臂4期管理（队列）试验，旨在确定口服Xa因子抑制剂利伐沙班对急性低风险PE进行家庭治疗是否可行、有效和安全。确诊为PE且右心室无功能障碍、右心房或右心室内无游离血栓的患者，如果不符合任何表明血流动力学不稳定、严重合并症或任何需要住院治疗的情况，或不符合家庭环境无法支持家庭治疗的排除标准，则符合入选条件。利伐沙班的首剂在医院给药，患者在就诊后48小时内出院。利伐沙班服用至少三个月。主要结局是入组后三个月内出现症状性复发性静脉血栓栓塞或PE相关死亡。次要结局包括生活质量和患者满意度，以及与现有标准疗程住院治疗数据相比的医疗资源利用情况。HoT-PE计划分析1050名入组患者，在α≤0.05时提供80%的检验效能以拒绝静脉血栓栓塞复发率>3%的零假设。如果HoT-PE的假设得到证实，早期出院和院外治疗可能会成为相当一部分急性PE患者有吸引力的潜在节省成本的选择。
