Balloon Pulmonary Angioplasty Versus Pulmonary Endarterectomy in Patients With Chronic Thromboembolic Pulmonary Hypertension: a Non-inferiority Randomized Trial

What this Trial Is About

Chronic thromboembolic pulmonary hypertension (CTEPH) is a rare, progressive disease that can be life-threatening and develops from unresolved pulmonary embolism. This research aims to compare two treatment options, balloon pulmonary angioplasty (BPA) and pulmonary endarterectomy (PEA), in patients eligible for both. The study is a multicenter, prospective, randomized, controlled, open-label trial designed to evaluate if BPA is not worse than PEA in these patients. Participants will be randomly assigned to receive either BPA or PEA. BPA typically involves 4 to 8 sessions using balloons to break fibrotic clots in the pulmonary arteries, with treatment details decided by the physician. Patients in the PEA group will undergo surgery within 4 months after randomization, where the thrombotic material is surgically removed. Both treatments must be completed within 6 months of randomization. During the study, participants will have follow-up visits at 4 months and 12 months after completing their assigned treatment. These visits include right heart catheterization and assessments of pulmonary vascular resistance and other heart and lung function measures. Researchers will also evaluate walking distance, clinical worsening, biomarkers, and quality of life. The total study duration covers treatment and follow-up periods to monitor outcomes and safety.

BPA vs. PEA in CTEPH