Pulmonary Embolism Clinical Trial
Official title:
Criteria for Hospitalization or Outpatient Management of Patients With Pulmonary Embolism, Hestia Rule Versus Simplified PESI Score : an Open-label Controlled Randomized International 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.
The approach featured in the most recent guidelines on acute PE of the European Society of
Cardiology, refers to an all-cause mortality risk assessment using the Pulmonary Embolism
Severity Index (PESI) score or the simplified PESI score (sPESI). The sPESI takes into
account demographics (age), patient history (cancer, cardiac or respiratory disease), and
clinical data (systolic blood pressure, heart rate, oxygen saturation). 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.
An alternative approach based on a list of simple criteria has been developed as the one used
in HESTIA study. The main criteria included in the HESTIA rule consist of absence of the
following: hemodynamic instability, need for oxygen therapy, high-risk of hemorrhage, renal
or liver failure, or other medical or social conditions requiring hospitalization.
The investigators hereby propose comparing these two approaches in an open-label, controlled
randomized international trial with blinded adjudication of endpoints.
The main objective is 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).
The major secondary objectives are 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 eventually managed as outpatients.
- As regards the rate of patients, in theory, eligible for outpatient care,
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 will
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.
The major objectives will test HESTIA based strategy versus sPESI based strategy in a
hierarchical approach:
- step 1: non-inferiority analysis on the rate of adverse events,
- if yes, step 2: superiority analysis on the rate of patients managed as outpatients,
- if yes, step3: superiority analysis on the rate of patients, in theory, eligible for
outpatient care.
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