Table 2.

Secondary endpoints that will be measured and/or compared at baseline and at 12 months after initiation of treatment

Endpoint
Change in 6 min walk distance
Change in Borg dyspnea index
Change in haemodynamic variables	Including pulmonary vascular resistance, mean right arterial pressure, cardiac output, etc.
Change in WHO functional class
Change in plasma brain natriuretic peptide levels
Change in SaO2 and PaO2
Change in usage volume of oxygen therapy	Including commencing oxygen therapy due to exacerbation of primary disease or dosage change.
Change in pulmonary function
Change in echocardiography parameter
Frequency and severity of pulmonary artery injury	Assessed by chest X-ray and chest CT scan.
Frequency of adverse events	Bloody sputum/hemoptysis/pulmonary haemorrhage (vascular perforation, vascular dissection, vascular rupture, etc), pneumothorax, hypotension, pulmonary congestion/pulmonary oedema, late-onset lung disturbance, heart failure, pneumonia, headache, dizziness, peripheral oedema, nausea/vomiting, retching, diarrhoea, nasopharyngitis, upper respiratory inflammation, respiratory distress, coughing and fainting.
Clinical worsening during the observation period and time to clinical worsening	All-cause mortality, heart/lung transplant, salvage PEA due to worsening of primary disease, new or repeated implementation of BPA due to the worsening of a primary disease, hospitalisation, new initiation of pulmonary vasodilators, worsening of 30% or greater from baseline in the 6 min walk distance and persistent worsening in the WHO functional class from baseline due to the worsening of a primary disease.
Change in quality-of-life parameters (EQ5D)
Health insurance resource costs

BPA, balloon pulmonary angioplasty; PaO₂, partial pressure of oxygen; PEA, pulmonary endarterectomy; SaO₂, saturation of arterial blood.