Pulmonary vascular disease & thromboembolism
Rationale and design of the PE-TRACT trial: A multicenter randomized trial to evaluate catheter-directed therapy for the treatment of intermediate-risk pulmonary embolism
Study context
- Population
- Patients with intermediate-risk pulmonary embolism (PE) (right heart dysfunction by imaging and cardiac biomarkers, normal BP)planned
- Participants
- 500 patients
- Planned comparison
- Catheter-directed therapy (CDT) plus anticoagulation vs anticoagulation alone
- Primary endpoint
- Peak VO2 with cardiopulmonary exercise testing (3 months), then New York Heart Association (NYHA) class (12 months), analysed sequentially by gatekeeping
- Follow-up
- 3 months (peak VO2); 12 months (NYHA class)
Methodological detailsdesign paper, open-label, assessor-blinded, multicentre, gatekeeping sequential analysis of 2 primary outcomes, Safety and cost-effectiveness will also be assessed
- Design paper
- Open-label
- Assessor-blinded
- Multicentre
- Gatekeeping sequential analysis of 2 primary outcomes
- Safety and cost-effectiveness will also be assessed
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
Rationale and design of the PE-TRACT trial: A multicenter randomized trial to evaluate catheter-directed therapy for the treatment of intermediate-risk pulmonary embolism. Am Heart J. Published 3 December 2024. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →