Hospitalization or Outpatient ManagEment of patients with Pulmonary Embolism: a randomized controlled trial - HOME-PE

Several studies have demonstrated the possibility of outpatient management or
early discharge for certain patients presenting acute pulmonary embolism (PE),
providing a suitable structure is in place.1 2 However, controversy persists
about the optimal referral strategies and eligibility criteria for outpatient
care.
The approach featured in the most recent guidelines on acute PE of the European
Society of Cardiology,3 refers to an all-cause mortality risk assessment using
the Pulmonary Embolism Severity Index (PESI) score or the simplified PESI score
(sPESI).4 The sPESI takes into account demographics (age), patient history
(cancer, cardiac or respiratory disease), and clinical data (systolic blood
pressure, heart rate, oxygen saturation).5 Outpatient care is offered to
low-risk patients, providing that all the conditions pertaining to start
anticoagulant treatment and follow-up at home are met.3
Recently, an alternative approach based on a list of simple criteria has been
developed as the one used in HESTIA study.6 The main criteria included in the
HESTIA rule consist of absence of the following: hemodynamic instability, need
for oxygen therapy, high-risk of haemorrhage, renal failure, liver failure, or
other medical or social conditions requiring hospitalization.6
Even though the proportion of *low-risk* PE patients eligible for outpatient
care and the proportion of patients treated at home seem higher, the rate of
complications does not seem to be increased when applying a strategy based on
HESTIA rule, as compared to the PESI or simplified PESI score.4 6 These
comparisons are however indirect and the two rules have never been compared
face to face.
We hereby propose comparing these two approaches in an open-label, controlled
randomized international trial with blinded adjudication of endpoints.

Main safety objective: To demonstrate, in normotensive PE patients, that a
strategy based on the HESTIA rule compared to a strategy based on the
simplified PESI score is at least as safe as regards the 30-day-rate of adverse
events (recurrent VTE, major bleeding or death).

Main efficacy objective: To demonstrate, in normotensive PE patients, that a
strategy based on the HESTIA rule compared to a strategy based on the
simplified PESI score is more effective:
As regards the rate of patients eligible for outpatient care,
As regards the rate of patients eventually managed as outpatients.

HOME-PE is a randomized controlled randomized multicentre international trial
with non-inferiority analysis for the main safety judgment criterion (rate of
adverse events) and superiority analysis for the two efficacy judgment criteria
(rate of patients eligible for outpatient care and percentage of patients
eventually treated as outpatients).
In the participating centres, specific structures based on a *thrombosis team*
for outpatient care of PE patients will be set up prior to study initiation.

All patients admitted in the Emergency Department of the participating centres
and diagnosed with PE will be eligible and assessed for potential inclusion.

Included patients will be randomized into two groups (1:1) and stratified by
centre. Data will be recorded in a computerized case report form (e-CRF)
enabling the randomization.

The HESTIA group will receive outpatient care proposal based on HESTIA
criteria. The sPESI group will receive outpatient care proposal based on the
simplified PESI score. Any reason for management (hospitalization or outpatient
treatment) not based on the recommendation must be explained and documented in
the e-CRF.

Follow-up will occur within 72 hours after inclusion, at 14 days, 1 month, and
3 months in both groups to gather clinical event data (recurrent VTE, major
bleeding, death), treatment data, unscheduled hospitalizations and patient
satisfaction assessment results.

An independent adjudication committee will evaluate all possible endpoints
blinded to the group allocation.
An independent data and safety monitoring board will periodically review the
study outcomes and advise the investigators.

HOME-PE is a randomized controlled randomized multicentre international trial
with non-inferiority analysis for the main safety judgment criterion (rate of
adverse events) and superiority analysis for the two efficacy judgment criteria
(rate of patients eligible for outpatient care and percentage of patients
eventually treated as outpatients).
In the participating centres, specific structures based on a *thrombosis team*
for outpatient care of PE patients will be set up prior to study initiation.

All patients admitted in the Emergency Department of the participating centres
and diagnosed with PE will be eligible and assessed for potential inclusion.

Included patients will be randomized into two groups (1:1) and stratified by
centre. Data will be recorded in a computerized case report form (e-CRF)
enabling the randomization.

The HESTIA group will receive outpatient care proposal based on HESTIA
criteria. The sPESI group will receive outpatient care proposal based on the
simplified PESI score. Any reason for management (hospitalization or outpatient
treatment) not based on the recommendation must be explained and documented in
the e-CRF.

not applicable