Anticoagulant Medicines for Balloon Pulmonary Angioplasty

Conditions: Chronic Thromboembolic Pulmonary Hypertension (CTEPH), Chronic Thromboembolic Disease (CTED)

Registration Number: NL-OMON22258

Lead Sponsor: St Antonius Hospital, Nieuwegein, the Netherlands

Brief Summary: /A

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 84

Inclusion Criteria

Established CTEPH or CTED diagnosis according to the guideline(12), with at least 3 months of anticoagulation treatment.
- Inoperable patients, patients reluctant to undergo surgery or patients with residual PH after PEA and accepted for BPA treatment.
- Accessible thromboembolic lesions for BPA.

Exclusion Criteria

- Operable CTEPH or CTED patients accepted for PEA.
- Contra-indications for BPA: right-sided mechanical heart valve, thrombus or myxoma in the right atrium or right-sided valvular endocarditis.
- Contra-indications for DOAC treatment: e.g. mechanical heart valves, myocardial thrombus, triple positive antiphospholipid syndrome, morbid obesity and (status after) bariatric treatment or major gastrointestinal resections and combination with CYP3A4 inhibitors and inductors. Anticoagulation dosage should be adjusted depending on renal function and drug interaction.
- High risk patients for bleeding complications: previous life-threatening bleeding (e.g. intracranial bleeding), age >80 years or pulmonary vascular resistance > 10 woods units (WU).
- Life-expectancy <1 year.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
A composite of periprocedural bleeding (life-threatening or disabling bleeding, vascular injury or access site complications) and lung injury within 24 hours after BPA on a per-session basis.

Secondary Outcome Measures

Name	Time	Method
- long-term safety of anticoagulant medicine in CTEPH/CTED patients receiving BPA on a per-patient basis.<br>- long-term efficacy of anticoagulant medicine and quality of life (QoL) in CTEPH/CTED patients receiving BPA on a per-patient basis.