About the Study
Study Title
Reperfusion Treatment in Acute Pulmonary Embolism: A Multicenter Observational Study in the Nordic Countries (PE-NORDIC)
Sponsor
Region Västra Götaland, Regionens Hus, 462 80 Vänersborg, Sweden
Principal Investigator
Kristina Svennerholm, Sahlgrenska University Hospital, Gothenburg, Sweden
Background
International guidelines recommend immediate reperfusion with systemic thrombolysis (ST) as first-line treatment in high-risk pulmonary embolism (PE). The therapy improves haemodynamics 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.
Several CDI methods are available, including mechanical thrombectomy (MT) and catheter-directed thrombolysis (CDT), but no method is currently recommended over the other. In Sweden, the MT device FlowTriever® (FT) was introduced in 2021 and has since then been the predominant method.
Treatment of acute PE using CDI is an evolving strategy as to techniques and availability. Follow-up of outcomes and safety is important when new techniques are employed. The PE-NORDIC observational study will evaluate short- and long-term safety and effect outcomes in patients with PE treated with CDI and ST in Sweden and other Nordic countries.
Study Design & Objectives
Objective
To evaluate short- and long-term outcomes among patients treated with CDI and to compare it to patients treated with ST for acute PE.
Design
Prospective multicenter observational cohort study.
Countries
Sweden, Denmark
Timeline
A three-year inclusion period, Q2 2025 – Q2 2028
Ethics
Approved by the Swedish Ethical Review Authority
Timeline
2025 | Q2 2025 – Q2 2028: Participant inclusion, informed consent, prospective data collection
Register the trial at ClinicalTrials.gov
2025 | Write and submit study protocol for peer-review in scientific journal
2028 | Processing and analyzing data, summarizing and interpreting results
Writing manuscript and submitting for peer-review in a scientific journal
Funding
This study is supported by the Department of Anaesthesia and Intensive Care, Sahlgrenska University Hospital, and the following grants:
- Gothenburg Medical Society (GLS-1001095)
- The Swedish Heart Lung Foundation (20240809)
- The Health & Medical Care Committee of the Region Västra Götaland (VGFOUREG-1010828)