For Participants
Patient Selection
Inclusion Criteria
✓ All adult patients (≥18 years), including pregnant women, with verified (CTPA, angiography or scintigraphy) acute PE who are planned for, or have received, treatment with CDI or ST
✓ 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 CDI trial
✗ Surgical embolectomy as primary reperfusion treatment
Study Groups
Included patients will be divided into two groups for comparison:
Intervention Group
Patients treated with Catheter-Directed Intervention (CDI)
Comparison Group
Patients treated with Systemic Thrombolysis (ST)
Study Activities
The data set includes variables from the following stages of the individual patient trajectories:
(table)
Study Outcomes
Primary Outcome
The primary outcome is a composite of death from any cause or severe bleeding according to GUSTO (defined as intracranial bleeding or bleeding with substantial hemodynamic compromise requiring treatment) at day 30 after treatment.
Secondary Outcomes
Within 30 days:
- All-cause mortality
- Cause of death
- Bleeding (according to GUSTO criteria)
- Need for rescue treatment (including ST, CDI, extracorporeal membrane oxygenation (ECMO), surgical embolectomy)
- Recurrent PE
- Hospital and intensive care unit (ICU) free days
- Change in right ventricular to left ventricular (RV/LV) ratio before and within 72 h after treatment
Within 1 year:
- Persisting dyspnea
- RV dysfunction
- ECG
- Cardiac biomarkers
- 6-minute walk test (6MWT) and sit-to-stand 60 test
- Health-related quality of life assessments
- Potential cases of confirmed chronic thromboembolic pulmonary vascular disease (CTED) or chronic thromboembolic pulmonary hypertension (CTEPH)
Additional Information
For any questions regarding participation in the PE-NORDIC study, please contact the study coordinators: