Pulmonary vascular disease & thromboembolism
A prospective, multicenter, randomized controlled trial evaluating anticoagulation alone vs anticoagulation plus computer assisted vacuum thrombectomy for the treatment of intermediate-high-risk acute pulmonary embolism: Rationale and design of the STORM-PE study
Study context
- Population
- Confirmed acute intermediate-high-risk pulmonary embolism (PE) with right ventricular (RV) dysfunction (RV/LV ratio ≥1.0) and elevated cardiac biomarkersup to 100 planned
- Planned comparison
- Anticoagulation (AC) plus computer assisted vacuum thrombectomy (CAVT) vs AC alone
- Primary endpoint
- Mean change in RV/LV ratio, assessed by CT pulmonary angiography and adjudicated by a blinded independent imaging Core Lab
- Follow-up
- 48 hours
Methodological detailsprospective, multicenter, post-market, international, open-label, 1:1 randomisation, blinded independent imaging Core Lab, Additional endpoints through 90 days: composite major adverse events, functional outcomes, quality of life, mortality, symptomatic PE recurrence, Clinical Events Committee adjudicates adverse events; independent Data Safety Monitoring Board oversees the study
- Prospective
- Multicenter
- Post-market
- International
- Open-label
- 1:1 randomisation
- Blinded independent imaging Core Lab
- Additional endpoints through 90 days: composite major adverse events, functional outcomes, quality of life, mortality, symptomatic PE recurrence
- Clinical Events Committee adjudicates adverse events; independent Data Safety Monitoring Board oversees the study
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
A prospective, multicenter, randomized controlled trial evaluating anticoagulation alone vs anticoagulation plus computer assisted vacuum thrombectomy for the treatment of intermediate-high-risk acute pulmonary embolism: Rationale and design of the STORM-PE study. Am Heart J. Published 31 March 2025. doi:10.
Summarised from the published abstract; every number is checked against it