Reperfusion Treatment in Acute Pulmonary Embolism
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Catheter directed intervention, any device, Alteplase.
- Who it may be relevant to
- Registry conditions: Pulmonary Embolism. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark, Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Reperfusion Treatment in Acute Pulmonary Embolism: A Multicenter Observational Study in the Nordic Countries
Overview
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.
Detailed description
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. Industry sponsored trials have investigated FT in uncontrolled observational trials and primarily in intermediate-risk PE. The investigator-initiated research on FT is limited to relatively small, descriptive, single-arm studies, or trials focusing on intermediate-risk PE.
There are several ongoing trials comparing different CDI methods to anticoagulation. However, in clinical practice, patients with acute PE may be subjected to different reperfusion strategies depending on severity and available resources. The PE-NORDIC observational study will compare the outcomes of different patient groups treated with current CDI methods used in the Nordic countries to patients treated with ST.
Interventions
- Procedure Catheter directed intervention, any device
Catheter directed intervention for treatment of pulmonary embolism - Drug Alteplase
Systemic thrombolysis
Primary outcome measures
- Composite of severe bleeding or mortality at 30 days [Time frame: From treatment to day 30 after treatment]
Secondary outcome measures (12)
- Mortality [Time frame: 30 days]
- Mortality [Time frame: 30 days]
- Bleeding [Time frame: 30 days]
- Rescue treatment [Time frame: 30 days]
- Recurrent PE [Time frame: 30 days]
- Hospital free days [Time frame: 30 days]
- ICU/HDU free days [Time frame: 30 days]
- Change in RV/LV ratio [Time frame: 72 hours]
- RV dysfunction [Time frame: 1 year]
- Persisting dyspnea [Time frame: 1 year]
- 6-minute walk test [Time frame: 1 year]
- Sit-to-stand 60 test [Time frame: 1 year]
Eligibility criteria
Inclusion criteria
- 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)
Exclusion criteria
- Ongoing enrolment in interventional catheter directed intervention trial
- Surgical embolectomy as primary reperfusion treatment
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Sweden · 10 centers
- Sahlgrenska University Hospital — Gothenburg
- Linköping University Hospital — Linköping
- Sunderby Hospital — Luleå
- Skåne University Hospital — Lund
- Örebro University Hospital — Örebro
- Danderyd Hospital — Stockholm
- Karolinska University Hospital Huddinge — Stockholm
- Karolinska University Hospital Solna — Stockholm
- … and 2 more centers
Denmark · 3 centers
- Aarhus University Hospital — Aarhus
- Rigshospitalet — Copenhagen
- Odense University Hospital — Odense
Publications
- Einarsson Askeli F, Andersen A, Glise Sandblad K, Martinell L, Pivodic A, Rylander C, Tavoly M, Svennerholm K; PE-NORDIC Investigators. Reperfusion treatment strategies in acute pulmonary embolism: Study protocol for a multicenter prospective observational study in the Nordic countries (PE-NORDIC). Thromb Res. 2026 Apr;260:109635. doi: 10.1016/j.thromres.2026.109635. Epub 2026 Mar 3. PMID 41812431
Identifiers
NCT: NCT07003646 · PE-NORDIC