Anticoagulant Medicines for Balloon Pulmonary Angioplasty

Rationale: Historically, all patients with chronic thromboembolic pulmonary hypertension (CTEPH) and chronic thromboembolic disease (CTED) were treated with vitamin K antagonists (VKAs). Nowadays, the use of direct oral anticoagulants (DOACs) is increasing. Nevertheless, it is unclear if DOACs are superior or inferior compared to VKAs in CTEPH patients receiving balloon pulmonary angioplasty (BPA) regarding (peri-procedural) bleeding, long-term (thrombotic) complications and clinical outcome.

Objective: We evaluate the safety and efficacy of DOACs versus VKAs in CTEPH/CTED patients receiving BPA. The effect of anticoagulant type on long-term safety and efficacy and quality of life in these patients is evaluated on a per-patient basis.

Study design: Multicentre, randomized controlled, open-label pilot trial.

Study population: All consecutive patients with an established CTEPH/CTED diagnosis and accepted for BPA treatment are eligible for inclusion in this study. Patients with an indication for a specific anticoagulation treatment, a high bleeding risk or a life-expectancy less than 1 year are excluded.

Intervention: The patients will be randomized to VKA or DOAC prior to the first BPA procedure.

Main study parameters/endpoints: The primary endpoint is the combination of periprocedural bleeding (life-threatening or disabling bleeding, vascular injury or access site problems) and lung injury within 24 hours after BPA, on a per-session basis. In addition, other (long-term) safety and efficacy endpoints will be assessed per-patient.

It is unclear if DOACs are superior or inferior compared to VKAs in CTEPH/CTED patients regarding (peri-procedural) bleeding and long-term (thrombotic) complications.

After each BPA and at 3,6, 12 and 18 months

VKA versus DOAC in CTEPH/CTED patients receiving BPA