'Thrombectomy in High-Risk Pulmonary Embolism - Device Versus Thrombolysis Netherlands': TORPEDO-NL

Inclusion Criteria:

1. Adult patients with confirmed acute PE, i.e. contrast filling defect in a lobar ormore proximal pulmonary artery on computed tomography pulmonary angiography (CTPA),and/or obstructive shock with echocardiographic confirmed dilatation of the rightventricle and a congested vena cava inferior, both with/without echocardiographicsigns of clot in transit or deep vein thrombosis of the leg.

2. High risk for mortality, i.e.

3. post cardiac arrest (after temporary need for cardiopulmonary resuscitation),OR

4. obstructive shock (systolic blood pressure <90 mmHg and signs of end-organhypoperfusion (e.g. elevated lactate levels >2 mmol/l) or the need forvasopressors (adrenalin or noradrenalin) to maintain an adequate bloodpressure), OR

5. persistent hypotension (systolic blood pressure <90 mmHg or systolic bloodpressure drop ≥40 mmHg for at least 15 minutes) not caused by new onsetarrhythmia, hypovolemia, or sepsis, OR

6. abnormal RV function on transthoracic echocardiography or CTPA AND elevatedcardiac troponin levels AND respiratory failure defined as hypoxemia (SaO2 <90%) refractory to O2 supplementation by nasal cannula or Venturi mask,requiring full face mask O2 supplementation (100% FiO2), high-flow nasal O2, or (non-)invasive mechanical ventilation.

7. CDT available and technically feasible so as to allow for a randomization-to-needletime of 60 minutes or less.

Exclusion Criteria:

1. "Catastrophic PE", i.e. ongoing cardiac arrest and/or need for extracorporealcardiopulmonary resuscitation (ECPR) and/or immediate indication for venoarterialextracorporeal membrane oxygenation (VA-ECMO) as judged by the responsiblephysician(s)

2. Glascow Coma Scale <8 following resuscitation for cardiac arrest

3. Alternative diagnosis than acute PE contributing largely to the acute hemodynamicand/or respiratory failure, e.g. sepsis, COPD GOLD 3 or 4, or known heart failurewith NYHA Functional Classification of 4, as judged by the treating physician.

4. A known "do not admit to the ICU" or "do not resuscitate" directive

5. An absolute contraindication to systemic thrombolysis, i.e.

• History of hemorrhagic stroke

• Ischemic stroke in past 6 months

• Central nervous system neoplasm

• Major trauma, major surgery or major head injury in past 3 weeks (note: mildexternal laceration of the head after, e.g. syncope, does not count as majorhead injury, especially when a CT scan of the head shows no hematoma)

• Active bleeding, life-threatening or into a critically organ/area; OR knownsevere bleeding diathesis with previous bleeding fulfilling these criteria

6. Reperfusion therapy (systemic thrombolysis, surgical thrombectomy or CDT/othercatheter directed therapy), or placement of a non-retrieved inferior vena cavafilter for acute pulmonary embolism in the past 3 months

7. Thrombus in transit through a patent foramen ovale.

8. Known chronic thromboembolic pulmonary hypertension (CTEPH), or strong suspicion ofCTEPH based on pre-existing clinical findings and combinations of signs of PEchronicity on echocardiography and/or CTPA.

9. Known hypersensitivity to systemic thrombolysis, heparin, or to any of theexcipients

10. If, in the Investigator's opinion, or after consultation with the local PERT-team orEC-members, the patient is not appropriate for thrombectomy

11. Chronic use of full-dose oral or parenteral anticoagulation before presentation.

12. Pregnancy

13. Current participation in another study that would interfere with participation inthis study

14. Previous enrolment in this study

15. Refusal of deferred consent by the next of kin or by the patient himself to use thedata. Deferred consent will not be asked to relatives of patients who die in scene,but are included in the study.