Pulmonary Embolism
Conditions
Keywords
Thrombolysis, Catheter-directed intervention, Aspirational thrombectomy, Catheter-directed tromboylsis, High-risk PE
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.
Interventions
PROCEDURECatheter directed intervention, any device
Catheter directed intervention for treatment of pulmonary embolism
DRUGAlteplase
Systemic thrombolysis
Sponsors
Sahlgrenska University Hospital
Stockholm South General Hospital
Karolinska University Hospital
Danderyd Hospital
University Hospital, Linkoeping
Sunderby Hospital
Aarhus University Hospital
Örebro University, Sweden
Odense University Hospital
Skane University Hospital
Rigshospitalet, Denmark
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite of severe bleeding or mortality at 30 days | From treatment to day 30 after treatment | A composite of severe bleeding according to GUSTO (defined as intracranial bleeding or bleeding with substantial hemodynamic com-promise requiring treatment) or death within 30 days after treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | 30 days | Incidence of all-cause mortality |
| Bleeding | 30 days | Defined by GUSTO criteria, severe/non-severe. |
| Rescue treatment | 30 days | Incidence of rescue treatment for PE (Systemic thrombolysis/Catheter-directed intervention/extracorporeal membrane oxygenation (ECMO)/surgical embolectomy) |
| Recurrent PE | 30 days | Clinically relevant recurrence of PE |
| Hospital free days | 30 days | Hospital free days between treatment and 30 days |
| ICU/HDU free days | 30 days | Intensive care unit (ICU) and/or high dependency unit (HDU) free days between treatment and 30 days |
| Change in RV/LV ratio | 72 hours | Change in right ventricular to left ventricular (RV/LV) diameter ratio before and within 72 h after treatment. |
| RV dysfunction | 1 year | Examined by echocardiogram in association with follow-up visit 1 and 2 |
| Persisting dyspnea | 1 year | Self-reported level of dyspnea at follow-up visit 1 compared to discharge date and at follow-up visit 2 to compared to visit 1. |
| 6-minute walk test | 1 year | Distance (meters) walked in a 6-minute walk test performed at follow-up visit 1 and 2 |
| Sit-to-stand 60 test | 1 year | Number of stand-ups performed in a sit-to-stand 60 test performed at follow-up visit 1 and 2 |
| PEmb-QoL | 1 year | Pulmonary Embolism Quality of Life Questionnaire. Disease-specific health-related quality of life. FC: Frequency of complaints (8 items, reverse scoring where lower scores correspond to better quality of life). AD: Activities of daily living limitations (13 items, reverse scoring where lower scores correspond to better quality of life). WR: Work-related problems (4 items, reverse scoring where lower scores correspond to better quality of life). SL: Social limitations (1 item). IC: Intensity of complaints (2 items). EC: Emotional complaints (10 items, reverse scoring where lower scores correspond to better quality of life). |
| MRC dyspnoea scale | 1 year | Medical research council dyspnoea scale. 0-4, a higher number corresponds to more dyspnoea. |
| EQ-5D-5L | 1 year | EuroQol 5-dimension 5-level questionnaire. Generic health-related quality of life assessment. Movement (1-5), 1 corresponds to high and 5 to low movement level (descriptive) Care (1-5), 1 corresponds to high and 5 to low care level (descriptive) Activity (1-5), 1 corresponds to high and 5 to low activity level (descriptive) Pain (1-5), 1 corresponds to low and 5 to high pain level (descriptive) Anxiety (1-5), 1 corresponds to low and 5 to high anxiety level (descriptive) EQ-VAS (0-100), where 0 corresponds to worst health and 100 to best possible |
| PVFS scale | 1 year | Post venous thromboembolism functional status scale (0-4) 0 corresponds to not affected of thromboembolism daily, 4 severely affected in daily life. |
| Incidence of CTEPH | 1 year | Incidence of chronic thromboembolic pulmonary hypertension (CTEPH) |
| Cardiac biomarkers | 1 year | Troponin and NTproBNP |
Countries
Denmark, Sweden
Contacts
CONTACTFreyr Einarsson, MD
CONTACTAnnika Odenstedt, coordinator
PRINCIPAL_INVESTIGATORKristina Svennerholm, Assoc Prof
Sahlgrenska University Hospital
Outcome results
None listed