About this trial
International guidelines recommend immediate reperfusion with systemic thrombolysis (ST) as first-line treatment in high-risk pulmonary embolism (PE). The therapy improves hemodynamics and overall survival but is also associated with a significant risk of severe bleeding. Catheter-directed intervention (CDI) is recommended as an alternative reperfusion therapy in high-risk PE when ST is contraindicated or has failed, as well as in patients who deteriorate or fail to improve during anticoagulation (AC) treatment. Despite lack of high-quality evidence and randomized studies between CDI and standard care, the use of CDI is spreading rapidly in high-risk PE and in less severe PE not fulfilling current treatment criteria.
Eligibility criteria
Qualifiers
All adult patients (≥18 years), including pregnant women, with verified (CTPA, angiography or scintigraphy) acute pulmonary embolism who are planned for, or have received, treatment with catheter directed intervention or systemic thrombolysis
Informed consent (for patients who do not survive before informed consent can be obtained, a waiver of consent applies)
Disqualifiers
Ongoing enrolment in interventional catheter directed intervention trial
Surgical embolectomy as primary reperfusion treatment
Trial design
Treatments tested in this trial
- Catheter directed intervention, any device
- Alteplase
Treatment groups
Sponsors and collaborators
Sahlgrenska University Hospital
Lead sponsor
Stockholm South General Hospital
Collaborator
Karolinska University Hospital
Collaborator
Danderyd Hospital
Collaborator
University Hospital, Linkoeping
Collaborator
Sunderby Hospital
Collaborator
Aarhus University Hospital
Collaborator
Örebro University, Sweden
Collaborator
Odense University Hospital
Collaborator
Skane University Hospital
Collaborator
Rigshospitalet, Denmark
Collaborator