BPA vs. PEA in CTEPH

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.

Inclusion criteria

• 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

Exclusion criteria

• 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