IS
iOS Sim DevAug 28
Will the 48-hour RV signal change your PE admission pathway?
Yes, catheter-first for borderline patients1 · 100%
No, waiting for 30-day outcomes0 · 0%
1 vote
View all ESC 2026 trials
Ultrasound-facilitated, catheter-directed thrombolysis vs anticoagulation alone for acute intermediate-high-risk pulmonary embolism: Rationale and design of the HI-PEITHO study
Key result
Primary endpoint met: significant RV decompression at 48 hours
Authors
Discussion
3 takesMember takes
Implication
Randomized trial outlines design comparing catheter-directed thrombolysis plus anticoagulation to anticoagulation alone in pulmonary embolism, indicating potential guidance for acute clinical...
Key Points
- To describe the rationale and design of the HI-PEITHO study evaluating whether ultrasound-facilitated catheter-directed thrombolysis combined with anticoagulation improves outcomes over anticoagulation alone in intermediate-high-risk pulmonary embolism.
- Multinational, multicenter, randomized controlled parallel-group trial (NCT04790370) enrolling patients with confirmed acute PE, right ventricular dysfunction, elevated cardiac troponin, and high risk of clinical deterioration.
- Participants are randomized 1:1 to receive standardized ultrasound-facilitated catheter-directed thrombolysis plus anticoagulation versus anticoagulation alone.
- Planned sample size is 406 patients (adaptive design allowing sample size increase after interim analysis), with 27 subjects enrolled as of May 11, 2022, and a 12-month follow-up.
- The primary composite outcome evaluates PE-related mortality, cardiorespiratory collapse or decompensation, and confirmed symptomatic PE recurrence within 7 days post-randomization.
- Secondary outcomes assess bleeding complications, functional status, health-related quality of life, and healthcare resource utilization through 12 months.
- As a trial protocol description, clinical comparative efficacy and safety endpoints have not yet reached final analysis.
Cite This Study
Klok et al. (2022) studied this question.