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Hestia 或简化 PESI 标准对急性肺栓塞进行家庭治疗分诊:HOME-PE 随机试验。

Triaging acute pulmonary embolism for home treatment by Hestia or simplified PESI criteria: the HOME-PE randomized trial.

机构信息

Emergency Department, CHU Angers, 4 rue Larrey, Angers, France, F-49000.

Univ. Angers, INSERM, CNRS, MITOVASC, Equipe CARME, SFR ICAT, Angers, France.

出版信息

Eur Heart J. 2021 Aug 31;42(33):3146-3157. doi: 10.1093/eurheartj/ehab373.

Abstract

AIMS

The aim of this study is to compare the Hestia rule vs. the simplified Pulmonary Embolism Severity Index (sPESI) for triaging patients with acute pulmonary embolism (PE) for home treatment.

METHODS AND RESULTS

Normotensive patients with PE of 26 hospitals from France, Belgium, the Netherlands, and Switzerland were randomized to either triaging with Hestia or sPESI. They were designated for home treatment if the triaging tool was negative and if the physician-in-charge, taking into account the patient's opinion, did not consider that hospitalization was required. The main outcomes were the 30-day composite of recurrent venous thrombo-embolism, major bleeding or all-cause death (non-inferiority analysis with 2.5% absolute risk difference as margin), and the rate of patients discharged home within 24 h after randomization (NCT02811237). From January 2017 through July 2019, 1975 patients were included. In the per-protocol population, the primary outcome occurred in 3.82% (34/891) in the Hestia arm and 3.57% (32/896) in the sPESI arm (P = 0.004 for non-inferiority). In the intention-to-treat population, 38.4% of the Hestia patients (378/984) were treated at home vs. 36.6% (361/986) of the sPESI patients (P = 0.41 for superiority), with a 30-day composite outcome rate of 1.33% (5/375) and 1.11% (4/359), respectively. No recurrent or fatal PE occurred in either home treatment arm.

CONCLUSIONS

For triaging PE patients, the strategy based on the Hestia rule and the strategy based on sPESI had similar safety and effectiveness. With either tool complemented by the overruling of the physician-in-charge, more than a third of patients were treated at home with a low incidence of complications.

摘要

目的

本研究旨在比较 Hestia 规则与简化的肺栓塞严重指数(sPESI)在急性肺栓塞(PE)患者分诊中的作用,以确定哪些患者适合接受家庭治疗。

方法和结果

来自法国、比利时、荷兰和瑞士的 26 家医院的血压正常的 PE 患者被随机分配到 Hestia 或 sPESI 分诊组。如果分诊工具为阴性,且主治医生在考虑患者意见后认为不需要住院治疗,则可安排患者接受家庭治疗。主要结局为 30 天内复发性静脉血栓栓塞、大出血或全因死亡的复合结局(非劣效性分析,以 2.5%的绝对风险差异为界值),以及随机分组后 24 小时内出院的患者比例(NCT02811237)。从 2017 年 1 月至 2019 年 7 月,共纳入 1975 例患者。在符合方案人群中,Hestia 组的主要结局发生率为 3.82%(34/891),sPESI 组为 3.57%(32/896)(P=0.004 时具有非劣效性)。在意向治疗人群中,Hestia 组 38.4%(378/984)的患者接受家庭治疗,sPESI 组为 36.6%(361/986)(P=0.41 时具有优越性),30 天复合结局发生率分别为 1.33%(5/375)和 1.11%(4/359)。家庭治疗组均未发生复发性或致命性 PE。

结论

对于 PE 患者的分诊,基于 Hestia 规则和 sPESI 的策略具有相似的安全性和有效性。通过任何一种工具,并结合主治医生的否决权,超过三分之一的患者可接受家庭治疗,且并发症发生率较低。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/912a/8408662/51b8711e3f0f/ehab373f3.jpg

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