This study (HOME-PE2) is a multicenter, randomized controlled trial comparing home treatment versus hospitalization in patients with acute pulmonary embolism (PE) who have no clinical severity criteria according to the Hestia rule but present either right ventricular dysfunction or elevated cardiac troponin levels.
While outpatient management is considered safe for low-risk PE patients, the optimal management of patients without clinical severity but with signs of right ventricular strain or myocardial injury remains uncertain, and current guidelines are inconsistent. As a result, most of these patients are still hospitalized despite limited evidence supporting this approach.
The primary objective is to assess whether home treatment is non-inferior to hospitalization in terms of safety, defined by the 7-day rate of adverse events according to the EARTH consensus. Secondary objectives include evaluation of net clinical benefit, quality of life, functional status, and healthcare resource utilization, as well as exploration of sex-related differences and cost-effectiveness.
A total of 568 adult patients with confirmed PE will be randomized (1:1) to either home treatment with early discharge or standard hospitalization. Patients will be followed for 90 days.
Presentation to the Emergency Department or unscheduled consultation in one of the participating centers
Symptomatic PE objectively confirmed according to the European Society of Cardiology criteria 4 (either by i) a high-probability ventilation/perfusion lung scan, ii) a new contrast filling defect on spiral computed tomography, or iii) a new documentation by ultrasonography of a proximal DVT, i.e., thrombus in the popliteal vein or above, along with clinical signs of PE. All radiological tests used to diagnose PE will be interpreted by on-site radiologists or angiologists)
No clinical criteria mandating hospitalization according to the Hestia rule, i.e., negative Hestia rule
Right ventricular dysfunction - defined as a right ventricular (RV) to left ventricular (LV) diameter ratio > 1.0 on echocardiography (apical four-chamber or subcostal four-chamber view) or on CTPA (transverse plane) OR High-sensibility cardiac troponin I or T concentration above the upper limit of local normal value
Shock or hypotension (defined as systolic blood pressure <90 mmHg or a systolic pressure drop by ≥40 mmHg, for >15 minutes, if not caused by new-onset arrhythmia, hypovolemia, or sepsis)
Combined right ventricular dysfunction (RV/LV > 1.0 on imaging) AND troponin concentration above the upper limit of local normal value
Free floating thrombi in the right atrium or ventricle, if identified by routine echocardiography or CTPA
Active cancer other than basal or squamous-cell skin cancer defined at least with one of the following: i) cancer diagnosed within the last 6 months, ii) current anti-cancer treatment or during the 6 months before enrollment, iii) locally advanced or metastatic cancer
Parallel
Home treatment
Other interventionOutpatient management strategy for acute pulmonary embolism, including early discharge after diagnosis and initiation of anticoagulation therapy, with follow-up according to current guidelines and local practice.
Hospitalization
Other interventionInpatient management strategy for acute pulmonary embolism, including hospital admission and standard care with anticoagulation therapy according to current guidelines and local practice.
7-day composite incidence of adverse events (EARTH criteria)
Composite outcome defined according to the EARTH consensus, including the occurrence of any of the following events within 7 days after randomization: death possibly or confirmed to be related to pulmonary embolism (including death of undetermined cause), hemodynamic failure, respiratory failure, cardiac rhythm disorders requiring urgent treatment, major bleeding (according to ISTH definition), or recurrent venous thromboembolism (symptomatic pulmonary embolism or proximal deep vein thrombosis requiring treatment or modification of anticoagulation). All outcome events are adjudicated by an independent clinical events committee blinded to treatment allocation.
Net benefit at 7 days (hierarchical composite outcome)
Hierarchical composite outcome assessed using a win-ratio approach, including the following components in order of priority: death possibly or confirmed to be related to pulmonary embolism (including death of undetermined cause), hemodynamic failure, respiratory failure, cardiac rhythm disorders requiring urgent treatment, major bleeding (ISTH definition), recurrent venous thromboembolism (symptomatic pulmonary embolism or proximal deep vein thrombosis requiring treatment or modification of anticoagulation), non-major clinically relevant bleeding, unscheduled hospital presentations (all causes), and cumulative length of hospital stay.
Global health quality-of-life (short term)
Change over time in health-related quality of life assessed using the EQ-5D-5L questionnaire.
Functional status (short term)
Change over time in patient-reported functional status assessed using the Post-VTE Functional Status (PVFS) scale.
Composite incidence of major adverse events
Composite of all cause-death, recurrent venous thromboembolism and major bleeding
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