Pulmonary vascular disease & thromboembolism
Large-bore mechanical thrombectomy vs standard of care for acute high-risk pulmonary embolism: Rationale and design of the PERSEVERE randomized controlled trial
Study context
- Population
- High-risk pulmonary embolism (PE): proximal pulmonary thrombus on CT plus ≥1 of systolic hypotension/vasopressors, venous lactate ≥4 mmol/L with signs of obstructive shock, need for mechanical circulatory support, or resuscitated cardiac arrest; excluding known CTEPH and key absolute contraindications to systemic thrombolysisplanned mITT population
- Participants
- 200 participants
- Planned comparison
- Large-bore mechanical thrombectomy (LBMT) vs standard of care
- Primary endpoint
- Composite of:
- All-cause death
- Cardiac arrest requiring CPR
- Bailout to rescue treatment
- Major bleeding
- ECMO in place on day 7
- Follow-up
- Through hospital discharge or 7 days post randomization, whichever occurs first
Methodological detailsdesign paper, multinational, 1:1 randomisation, 40 sites in Europe and the US, Patients followed for 3 months, Secondary endpoints: functional and patient-reported outcomes (quality of life, functional status, healthcare resource utilization) at 3 months
- Design paper
- Multinational
- 1:1 randomisation
- 40 sites in Europe and the US
- Patients followed for 3 months
- Secondary endpoints: functional and patient-reported outcomes (quality of life, functional status, healthcare resource utilization) at 3 months
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
Large-bore mechanical thrombectomy vs standard of care for acute high-risk pulmonary embolism: Rationale and design of the PERSEVERE randomized controlled trial. Am Heart J. Published 24 December 2025. doi:10.
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