AIMS To investigate the efficacy and safety of early transition from hospital to ambulatory treatment in low-risk acute PE, using the oral factor Xa inhibitor rivaroxaban. METHODS AND RESULTS We conducted a prospective multicentre single-arm investigator initiated and academically sponsored management trial in patients with acute low-risk PE (EudraCT Identifier 2013-001657-28). Eligibility criteria included absence of (i) haemodynamic instability, (ii) right ventricular dysfunction or intracardiac thrombi, and (iii) serious comorbidities. Up to two nights of hospital stay were permitted. Rivaroxaban was given at the approved dose for PE for ≥3 months. The primary outcome was symptomatic recurrent venous thromboembolism (VTE) or PE-related death within 3 months of enrolment. An interim analysis was planned after the first 525 patients, with prespecified early termination of the study if the null hypothesis could be rejected at the level of α = 0.004 (<6 primary outcome events). From May 2014 through June 2018, consecutive patients were enrolled in seven countries. Of the 525 patients included in the interim analysis, three (0.6%; one-sided upper 99.6% confidence interval 2.1%) suffered symptomatic non-fatal VTE recurrence, a number sufficiently low to fulfil the condition for early termination of the trial. Major bleeding occurred in 6 (1.2%) of the 519 patients comprising the safety population. There were two cancer-related deaths (0.4%). CONCLUSION Early discharge and home treatment with rivaroxaban is effective and safe in carefully selected patients with acute low-risk PE. The results of the present trial support the selection of appropriate patients for ambulatory treatment of PE.

中文翻译：

---

口服 Xa 因子抑制剂利伐沙班对低危肺栓塞患者的早期出院和家庭治疗：一项国际多中心单臂临床试验

目的 研究使用口服 Xa 因子抑制剂利伐沙班在低危急性 PE 中早期从医院过渡到非卧床治疗的有效性和安全性。方法和结果 我们对急性低风险 PE 患者进行了一项前瞻性多中心单臂研究人员发起和学术赞助的管理试验（EudraCT Identifier 2013-001657-28）。合格标准包括没有 (i) 血流动力学不稳定，(ii) 右心室功能障碍或心内血栓，以及 (iii) 严重的合并症。最多允许住院两晚。利伐沙班以批准的 PE 剂量给药≥3 个月。主要结局是入组后 3 个月内有症状的复发性静脉血栓栓塞 (VTE) 或 PE 相关死亡。计划在前 525 名患者之后进行中期分析，如果可以在 α = 0.004（<6 个主要结果事件）的水平上拒绝零假设，则预先指定的研究提前终止。从 2014 年 5 月到 2018 年 6 月，连续招募了七个国家的患者。在纳入中期分析的 525 名患者中，3 名（0.6%；单侧 99.6% 置信区间上限为 2.1%）出现有症状的非致命性 VTE 复发，这一数字足够低，足以满足提前终止试验的条件。构成安全人群的 519 名患者中有 6 名 (1.2%) 发生大出血。有两例癌症相关死亡（0.4%）。结论 利伐沙班早期出院和家庭治疗对精心挑选的急性低危 PE 患者有效且安全。