BPA vs. PEA in CTEPH
ID: NCT05110066
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Chronic thromboembolic pulmonary hypertension (CTEPH) is a rare and potentially life-threatening progressive disease that evolves from unresolved pulmonary embolism. Gold standard treatment for CTEPH is pulmonary endarterectomy (PEA) performed by skilled cardio-thoracic surgeons. Some patients may not be surgical candidates due to co-morbidities or because the vascular lesions are too distal making them technically inoperable. In these patients, balloon pulmonary angioplasty (BPA) has emerged as an effective treatment. In a subgroup of patients, the distribution of vascular lesions makes it possible to perform either BPA or PEA. There has never been a head-to head comparison of BPA with PEA. The aim of this study is therefore, to evaluate if BPA is non-inferior to PEA in patients with (CTEPH) who are eligible for both treatments.
Read Full Scientific Objectives & Methods
An investigator-initiated multicenter, prospective, randomized, controlled, open label, non-inferiority trial. The study will randomize (1:1) 152 patients with CTEPH who are eligible for both PEA and BPA. Patients will be screened for study inclusion at the local CTEPH multidisciplinary team conference and eligibility for both PEA and BPA will be confirmed by a central adjudication committee. PEA or BPA will be completed within 6 months from randomization. Follow-up visit with right heart catheterization will be completed at 4 months and 12 months after PEA or last BPA session. Primary end-point is change in pulmonary vascular resistance from baseline to 4 months and 12 months after PEA or the last BPA session.
Surgical pulmonary endarterectomy is done by a thoracic surgical procedure by removing chronic thrombotic material by intimal dissection with patient on cardiopulmonary bypass.
Percutaneous balloon pulmonary angioplasty is performed using standard percutaneous technique to break the fibrotic clots in the pulmonary arteries using percutaneous transluminal angioplasty balloons.
Treatment Arms Description
Balloon pulmonary angioplasty. Typically 4-8 sessions are needed to treat the patient. The specific pre-planning protocol, choice of wires and balloons, the number of vessels treated per session, and the decision that no further BPA sessions are needed is at the discretion of the treating physician.
Patients randomized to PEA will undergo surgery within 4 months after randomization and optional run-in phase. Distality of the dissection plane is at the discretion of the operating physicians.
- Diagnosed with chronic thromboembolic pulmonary hypertension according to current European society of cardiology/European Respiratory Society guidelines and eligible for both pulmonary endarterectomy and ballon pulmonary angioplasty by decision at the local multidisciplinary team conference and central adjudication committee
- Written informed consent from the patient
- Patient age \>17 and \<80 years
- Able to understand and follow instructions and to participate in the entire study period
- Life expectancy \<12 months
- Co morbidities evaluated at the multidisciplinary team conference, that contributes significantly to the patients pulmonary hypertension
- Not possible to perform balloon pulmonary angioplasty or pulmonary endarterectomy within 4 months after randomization.
- Evaluated at multidisciplinary team conference that changes in pulmonary artery hypertension targeted therapy between baseline and 4 months follow-up is inevitable\*
- Known pregnancy or positive urine Human chorionic gonadotropin screening test in fertile women
- Previous balloon pulmonary angioplasty or pulmonary endarterectomy
Primary Outcome Measures
- Change in pulmonary vascular resistance — Time Frame: 4 months and 12 months
Change in pulmonary vascular resistance from baseline to 4-months and 12-months after the procedure(s). Patients on medical treatments at baseline will remain on medical treatments until the assessment of the primary endpoint, and be taken off if hemodynamics permit
View Secondary Outcome Measures (7)
- Mean pulmonary artery pressure — Time Frame: 4 months and 12 months
Mean pulmonary artery pressure measured by right heart catheterization
- Cardiac index — Time Frame: 4 months and 12 months
Cardiac index measured by right heart catheterization
- Mean right atrial pressure — Time Frame: 4 months and 12 months
Right atrial pressure measured by right heart catheterization
- Six minutes walking distance — Time Frame: 4 months and 12 months
Six minutes walking distance
- Time to clinical worsening — Time Frame: 4 months and 12 months
Clinical worsening includes all-cause mortality, nonelective hospitalization for pulmonary artery hypertension, and disease progression (disease progression is defined as a reduction from baseline in the six minutes walking distance by 15% plus worsening functional class (except for patients already in Orld health organization functional class IV).)
- N-terminal pro B-type natriuretic peptide — Time Frame: 4 months and 12 months
N-terminal pro B-type natriuretic peptide
- Quality of life evaluated by the "Living with pulmonary hypertension questionnaire" — Time Frame: 4 months and 12 months
Measured by the use of Living with pulmonary hypertension questionnaire (21 questions scored 0-5. Minimum score is 0 and maximum score is 105. Low score means high quality of life and a high score means a low quality of life).
This trial is recruiting at 2 study facilities worldwide. Click below to see if there is a clinic or hospital in your area:
Show All 2 Facilities & Contact Sites
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- Riedel M, Stanek V, Widimsky J, Prerovsky I. Longterm follow-up of patients with pulmonary thromboembolism. Late prognosis and evolution of hemodynamic and respiratory data. Chest. 1982 Feb;81(2):151-8. doi: 10.1378/chest.81.2.151.PubMed ↗
View Official Medical/Scientific Title
Balloon Pulmonary anGiOplasty Versus Pulmonary Endarterectomy in Patients With Chronic ThromboEmbolic Pulmonary Hypertension: a Non-inferiority Randomized Trial