Clinical trial NCT07003646: Reperfusion Treatment in Acute Pulmonary Embolism
Official title: Reperfusion Treatment in Acute Pulmonary Embolism: A Multicenter Observational Study in the Nordic Countries
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pulmonary Embolism
Keywords: Thrombolysis
Catheter-directed intervention
Aspirational thrombectomy
Catheter-directed tromboylsis
High-risk PE
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
Collaborators: name: Stockholm South General Hospital
name: Karolinska University Hospital
name: Danderyd Hospital
name: University Hospital, Linkoeping
name: Sunderby Hospital
name: Aarhus University Hospital
name: Örebro University, Sweden
name: Odense University Hospital
name: Skane University Hospital
name: Rigshospitalet, Denmark
First posted: 2025-06-04
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pulmonary embolism patients treated with catheter directed intervention or systemtic thrombolysis in hospitals in Sweden and Denmark where the former treatment modality is established.

Brief summary: 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.

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

Primary outcomes:
measure: Composite of severe bleeding or mortality at 30 days
timeFrame: From treatment to day 30 after treatment
Secondary outcomes:
measure: Mortality
timeFrame: 30 days
measure: Mortality
timeFrame: 30 days
measure: Bleeding
timeFrame: 30 days
measure: Rescue treatment
timeFrame: 30 days
measure: Recurrent PE
timeFrame: 30 days
measure: Hospital free days
timeFrame: 30 days
measure: ICU/HDU free days
timeFrame: 30 days
measure: Change in RV/LV ratio
timeFrame: 72 hours
measure: RV dysfunction
timeFrame: 1 year
measure: Persisting dyspnea
timeFrame: 1 year
measure: 6-minute walk test
timeFrame: 1 year
measure: Sit-to-stand 60 test
timeFrame: 1 year
measure: PEmb-QoL
timeFrame: 1 year
measure: MRC dyspnoea scale
timeFrame: 1 year
measure: EQ-5D-5L
timeFrame: 1 year
measure: PVFS scale
timeFrame: 1 year
measure: Incidence of CTED/CTEPH
timeFrame: 1 year
measure: Cardiac biomarkers
timeFrame: 1 year
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Odense
country: Denmark
facility: Odense University Hospital
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
city: Linköping
country: Sweden
facility: Linköping University Hospital
city: Luleå
country: Sweden
facility: Sunderby Hospital
city: Lund
country: Sweden
facility: Skåne University Hospital
city: Stockholm
country: Sweden
facility: Danderyd Hospital
city: Stockholm
country: Sweden
facility: Karolinska University Hospital Huddinge
city: Stockholm
country: Sweden
facility: Karolinska University Hospital Solna
city: Stockholm
country: Sweden
facility: Södersjukhuset
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
city: Örebro
country: Sweden
facility: Örebro University Hospital
Study officials:
affiliation: Sahlgrenska University Hospital
name: Kristina Svennerholm, Assoc Prof
role: PRINCIPAL_INVESTIGATOR
References: