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

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.

Keywords: Clinical decision-making; Emergency department; Home treatment; Pulmonary embolism; Randomized controlled trial; Risk assessment.

The international randomized HOME-PE study demonstrates that, for triaging patients with acute pulmonary embolism for home treatment, the Hestia rule and the simplified Pulmonary Embolism Severity Index, complemented by the physician's overruling, are equally safe and efficient.

Figure 1

Enrolment, randomization, and follow-up. Among randomized patients, three subsequently withdrew consent in the Hestia arm and one in the sPESI arm; 77 patients were excluded from the per-protocol population in the Hestia arm: 13 for disregard of the inclusion or exclusion criteria (for 6 patients the initial diagnosis of acute pulmonary embolism was subsequently refuted, 2 patients had systolic blood pressure <90 mmHg at baseline, 2 had a time interval between emergency department presentation and inclusion >48 h, and 3 patients had a time interval between pulmonary embolism diagnosis and inclusion >24 h), 63 for disregard of the protocol strategy (32 were designated for home treatment but discharged home more than 24 h after randomization and 31 were designated for hospitalization but discharged within 24 h following randomization), and 1 for both protocol deviations (unconfirmed pulmonary embolism diagnosis and designated for hospitalization but discharged within 24 h following randomization); 85 patients were excluded from the per-protocol population in the sPESI arm: 18 for disregard of the inclusion or exclusion criteria (for 12 patients, the initial diagnosis of acute pulmonary embolism was subsequently refuted, 3 had a time interval between emergency department presentation and inclusion >48 h, and 3 patients had a time interval between pulmonary embolism diagnosis and inclusion >24 h), 64 for disregard of the protocol strategy (31 were designated for home treatment but discharged home more than 24 h after randomization and 33 were designated for hospitalization but discharged within 24 h following randomization), and 3 for both protocol deviations (2 with unconfirmed pulmonary embolism diagnosis and designated for hospitalization but discharged within 24 h following randomization, and 1 with a time interval between emergency department presentation and inclusion >48 h, and designated for home treatment but discharged home more than 24 h after randomization).

Figure 2

Selection for home treatment. The selection for home treatment included three steps. Step 1: Qualification for home treatment according to the allocated triaging tool. Patients randomized to the Hestia arm qualified for home treatment if all answers were negative. Patients randomized to the sPESI arm qualified for home treatment if the sPESI was 0 points. Step 2: Designation for home treatment according to the physician-in-charge. In both study arms, for designation for home treatment and as per-protocol, the physician-in-charge could overrule the qualification issued from the allocated triaging tool in case of imperative medical or social reasons, or patient’s refusal. The reasons are mentioned in the lateral boxes. Step 3: Final management. Patients were considered to have been treated at home if they were actually discharged within 24 h following randomization, calculated from the patients’ administrative report forms. Protocol deviations were defined as patients designated for home treatment who were discharged after the 24-h limit, or vice versa, as patients designated for hospitalization who were discharged before the 24-h limit. DOAC, direct oral anticoagulant; LMWH, low molecular weight heparin.