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. 2025 Mar:281:112-122.
doi: 10.1016/j.ahj.2024.11.016. Epub 2024 Dec 3.

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

Akhilesh K Sista  1 , Andrea B Troxel  2 , Thaddeus Tarpey  3 , Sameer Parpia  4 , Samuel Z Goldhaber  5 , William W Stringer  6 , Elizabeth A Magnuson  7 , David J Cohen  8 , Susan R Kahn  9 , Sunil V Rao  10 , Timothy A Morris  11 , Keith S Goldfeld  12 , Suresh Vedantham  13
Affiliations

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

Akhilesh K Sista et al. Am Heart J. 2025 Mar.

Abstract

Background: The optimal management of patients with intermediate-risk pulmonary embolism (PE), who have right heart dysfunction (determined by a combination of imaging and cardiac biomarkers) but a normal blood pressure, is uncertain. These patients suffer from reduced functional capacity and a lower quality of life over the long-term, despite use of anticoagulant therapy. Catheter-directed therapy (CDT) is a promising treatment for acute PE that rapidly removes thrombus and potentially improves cardiac dysfunction. However, CDT has risk and is costly, and it is not known whether it improves long-term cardiorespiratory fitness and/or quality of life compared with anticoagulation alone.

Methods: We are therefore conducting an open-label, assessor-blinded, multicenter randomized trial, the Pulmonary Embolism: Thrombus Removal with Catheter-Directed Therapy (PE-TRACT) Study, to compare CDT plus anticoagulation (CDT group) with anticoagulation alone (No-CDT group) in 500 patients with intermediate-risk PE. The primary study hypothesis is that CDT will increase the peak oxygen uptake (peak VO2) with cardiopulmonary exercise testing at 3 months and reduce New York Heart Association (NYHA) Class at 12 months compared with No-CDT. These 2 primary efficacy outcomes will be analyzed sequentially using a "gatekeeping" procedure; for NYHA class to be compared, peak oxygen consumption must first be shown to be significantly increased by CDT. Safety and cost-effectiveness will also be assessed.

Conclusion: When completed, PE-TRACT will provide important evidence regarding the benefits and risks of CDT to treat intermediate-risk PE compared with anticoagulation alone.

Trial registration: clinicaltrials.gov: NCT05591118.

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Conflict of interest statement

Declaration of competing interest David J. Cohen received research grant support from Abbott Vascular, Boston Scientific, Medtronic, Philips, Zoll medical Elixir Medical and consulting income from Abbott Vascular, Boston Scientific and Medtronic. Tim Morris received Research grant support from Inari Medical. William Stringer is a consultant for several firms, including Verona, Regeneron, and Genentech. The other authors have no conflict of interest.

References

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