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.
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.
Study Type
OBSERVATIONAL
Enrollment
220
Catheter directed intervention for treatment of pulmonary embolism
Systemic thrombolysis
Aarhus University Hospital
Aarhus, Denmark
RECRUITINGRigshospitalet
Copenhagen, Denmark
RECRUITINGOdense University Hospital
Odense, Denmark
RECRUITINGSahlgrenska University Hospital
Gothenburg, Sweden
RECRUITINGLinköping University Hospital
Linköping, Sweden
RECRUITINGSunderby Hospital
Luleå, Sweden
RECRUITINGSkåne University Hospital
Lund, Sweden
RECRUITINGÖrebro University Hospital
Örebro, Sweden
RECRUITINGDanderyd Hospital
Stockholm, Sweden
RECRUITINGKarolinska University Hospital Huddinge
Stockholm, Sweden
RECRUITING...and 3 more locations
Composite of severe bleeding or mortality at 30 days
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
Time frame: From treatment to day 30 after treatment
Mortality
Incidence of all-cause mortality
Time frame: 30 days
Mortality
Cause of death
Time frame: 30 days
Bleeding
Defined by GUSTO criteria, severe/non-severe.
Time frame: 30 days
Rescue treatment
Incidence of rescue treatment for PE (Systemic thrombolysis/Catheter-directed intervention/extracorporeal membrane oxygenation (ECMO)/surgical embolectomy)
Time frame: 30 days
Recurrent PE
Clinically relevant recurrence of PE
Time frame: 30 days
Hospital free days
Hospital free days between treatment and 30 days
Time frame: 30 days
ICU/HDU free days
Intensive care unit (ICU) and/or high dependency unit (HDU) free days between treatment and 30 days
Time frame: 30 days
Change in RV/LV ratio
Change in right ventricular to left ventricular (RV/LV) diameter ratio before and within 72 h after treatment.
Time frame: 72 hours
RV dysfunction
Examined by echocardiogram in association with follow-up visit 1 and 2
Time frame: 1 year
Persisting dyspnea
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.
Time frame: 1 year
6-minute walk test
Distance (meters) walked in a 6-minute walk test performed at follow-up visit 1 and 2
Time frame: 1 year
Sit-to-stand 60 test
Number of stand-ups performed in a sit-to-stand 60 test performed at follow-up visit 1 and 2
Time frame: 1 year
PEmb-QoL
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).
Time frame: 1 year
MRC dyspnoea scale
Medical research council dyspnoea scale. 0-4, a higher number corresponds to more dyspnoea.
Time frame: 1 year
EQ-5D-5L
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
Time frame: 1 year
PVFS scale
Post venous thromboembolism functional status scale (0-4) 0 corresponds to not affected of thromboembolism daily, 4 severely affected in daily life.
Time frame: 1 year
Incidence of CTEPH
Incidence of chronic thromboembolic pulmonary hypertension (CTEPH)
Time frame: 1 year
Cardiac biomarkers
Troponin and NTproBNP
Time frame: 1 year
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