Overview
Main objective of this multisite randomised study aims to demonstrate in patients with active cancer and symptomatic or incidental PE without HESTIA criteria, that home treatment is non-inferior to hospitalisation as regards the 14-day rate of the composite primary endpoint.
Primary endpoint corresponds to the rate of the composite of centrally adjudicated recurrent incidental or symptomatic VTE (i.e. non fatal or fatal PE, proximal and/or distal deep venous thrombosis (DVT) of lower limb or upper limb or catheter-related thrombosis), major or clinically relevant non-major bleeding and all-cause death within 14 days following randomisation. This composite endpoint represents the net clinical benefit of outpatient care.
Included patients will be randomised into two groups and stratified according to symptomatic or incidental PE, site of cancer, localised or metastatic cancer and centre.
Patients randomised to the home-treatment group will be discharged home within 24hrs after randomisation. Patients will be contacted by the local thrombosis team by phone within 7 days following inclusion.
Patients randomised to the hospitalisation group will be admitted in the hospital during at least 48hrs after randomisation. After this time, physicians in charge of the patients will be free to discharge the patients.
Description
Several studies have demonstrated that patients with low-risk pulmonary embolism (PE), selected on simplified PE Severity Index (sPESI) = 0 or without HESTIA criteria, can be safely treated at home. The HOME-PE study demonstrated that HESTIA rule was at least as safe as sPESI score for triaging patients with PE. With both strategies, almost 35% of patients could be managed at home with a low rate of complications (" 1% at Day-30).
PE is a common complication in patients with cancer who are at higher risk for recurrence of venous thromboembolism (VTE), bleeding and PE-related death than patients without cancer. For these reasons, some decision-making tools categorise all patients with cancer at risk of complications and are therefore not eligible for home treatment. In a post hoc analysis of the HOME-PE trial, the 30-day rate of adverse events was higher in patients with active cancer treated at home (4.3%) than in those without (1.0%), but was comparable in patients with cancer hospitalised only because of cancer (3.0%). Home treatment was not a risk factor of complications among cancer patients. Interestingly, 90% of these complications occurred after day-10 suggesting that hospitalisation did not avoid the occurrence of adverse events. Moreover, approximately 50% of PE in patients with cancer is now incidentally detected on imaging undertaken for cancer staging or evaluation of treatment response with a prevalence up to 5%. These patients should be managed in the same manner as symptomatic PE since they have similar prognosis. However, hospitalisation is sometimes challenging in daily practice (availability of bed…) and some of these patients are currently treated at home despite the absence of evidence on the safety of such management.
Home treatment is important for retaining autonomy of patients and may improve their perception of health and quality of life which are particularly relevant for cancer patients. However, this expected benefit have never been confirmed in a prospective trial.
We propose to assess in a randomised controlled trial whether home treatment of patients with active cancer and symptomatic or incidental PE with a negative HESTIA rule is at least as safe as hospitalisation. Furthermore, we will assess the impact of home treatment on several patient-centred outcomes as well as medico-economic issues.
The results are expected to help to define the best management strategy and will provide high level of evidence for cancer associated PE patient care in terms of safety, efficacy and efficiency.
Included patients will be randomised into two groups (1:1) and stratified according to symptomatic or incidental PE, site of cancer, localised or metastatic cancer and centre.
Patients randomised to the home-treatment group will be discharged home within 24hrs after randomisation. Patients will be contacted by the local thrombosis team by phone within 7 days following inclusion.
Patients randomised to the hospitalisation group will be admitted in the hospital during at least 48hrs after randomisation. After this time, physicians in charge of the patients will be free to discharge the patients.
Data will be recorded in a computerised case report form (e-CRF) enabling randomisation between home treatment and hospitalisation. In both groups, physicians in charge of the patients will prescribe anticoagulant according to local protocols. Anticoagulant treatment will be started at the latest immediately after PE diagnosis. All patients will be instructed to contact the local thrombosis team or to report to the ED in case of any new symptoms suggestive of VTE or any bleeding episodes occur. Follow-up will occur at 7, 14, 30 and 90 days after inclusion in both groups to gather clinical events (recurrent VTE, major or clinically relevant bleeding, death), patients-centred outcomes (EQ-5D-5L, PEmbQoL, ACTS) and patients resource utilisation. An independent adjudication committee will evaluate all clinical endpoints blinded to the group allocated.
Eligibility
Inclusion Criteria:
- Age ≥ 18 years
- Symptomatic or incidental hemodynamically stable PE objectively confirmed ≤ 24h according to the ESC guidelines
- Active cancer other than basal-cell or squamous-cell carcinoma of the skin defined at least by one of the followings:
- cancer that has been diagnosed within the past 6 months,
- cancer for which anti-cancer treatment is being given at the time of enrolment or during 6 months before randomisation, or recurrent locally advanced or metastatic cancer
- No HESTIA criteria (i.e. no other medical condition than cancer since cancer is one of the medical condition that can check "yes" to the item).
- For woman of childbearing potential: negative beta-HCG before inclusion
- Signed informed consent
- Affiliated to French " sécurité sociale "
- Good understanding of the French language
Exclusion Criteria:
- Diagnosis of PE established for over 24h before inclusion
- 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, hypovolaemia, or sepsis
- Hospitalisation for over 24h
- ECOG performans status 3 or 4
- Impossibility for 30-day follow-up,
- Estimated life expectancy less than 30 days
- Patient in detention by judicial or administrative decision,
- Patient placed under a legal protection measure,
- Patient unable of giving free and informed consent
- Inclusion in another interventional study requiring hospitalisation
- Pregnant or breastfeeding women
- Patient on AME (state medical aid)
