Comparing catheter-directed thrombectomy to thrombolysis for high-risk pulmonary embolism

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

This study is testing if a new procedure called catheter-directed thrombectomy can help people with high-risk pulmonary embolism do better than the standard treatment of full-dose thrombolysis.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 111 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Leiden University Medical Center (Academic / other)
• Locations: 1 site (Leiden, South Holland)
• Trial ID: NCT06833827 on ClinicalTrials.gov

What this trial studies

TORPEDO-NL is an investigator-initiated, multicentre, open-label, randomized controlled trial designed to evaluate the effectiveness of catheter-directed thrombectomy (CDT) compared to full-dose systemic thrombolysis in patients with high-risk pulmonary embolism (PE). The study aims to determine if CDT can reduce mortality and adverse events associated with treatment, given the significant risks of bleeding with thrombolysis. Patients will be closely monitored for outcomes related to mortality and treatment failure, providing critical data on the safety and efficacy of this alternative approach.

Who should consider this trial

Good fit: Ideal candidates for this study are adult patients with confirmed acute pulmonary embolism who are at high risk for mortality.

Not a fit: Patients with low-risk pulmonary embolism or those who do not meet the inclusion criteria will likely not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a safer and more effective treatment option for patients with high-risk pulmonary embolism.

How similar studies have performed: While catheter-directed thrombectomy is a promising alternative, randomized trials evaluating its safety and efficacy in high-risk patients are currently lacking, making this approach novel.

Eligibility criteria

Inclusion Criteria:

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

   1. post cardiac arrest (after temporary need for cardiopulmonary resuscitation), OR
   2. obstructive shock (systolic blood pressure \<90 mmHg and signs of end-organ hypoperfusion (e.g. elevated lactate levels \>2 mmol/l) or the need for vasopressors (adrenalin or noradrenalin) to maintain an adequate blood pressure), OR
   3. persistent hypotension (systolic blood pressure \<90 mmHg or systolic blood pressure drop ≥40 mmHg for at least 15 minutes) not caused by new onset arrhythmia, hypovolemia, or sepsis, OR
   4. abnormal RV function on transthoracic echocardiography or CTPA AND elevated cardiac 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.
3. CDT available and technically feasible so as to allow for a randomization-to-needle time of 60 minutes or less.

Exclusion Criteria:

1. "Catastrophic PE", i.e. ongoing cardiac arrest and/or need for extracorporeal cardiopulmonary resuscitation (ECPR) and/or immediate indication for venoarterial extracorporeal membrane oxygenation (VA-ECMO) as judged by the responsible physician(s)
2. Glascow Coma Scale \<8 following resuscitation for cardiac arrest
3. Alternative diagnosis than acute PE contributing largely to the acute hemodynamic and/or respiratory failure, e.g. sepsis, COPD GOLD 3 or 4, or known heart failure with 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: mild external laceration of the head after, e.g. syncope, does not count as major head injury, especially when a CT scan of the head shows no hematoma)
   * Active bleeding, life-threatening or into a critically organ/area; OR known severe bleeding diathesis with previous bleeding fulfilling these criteria
6. Reperfusion therapy (systemic thrombolysis, surgical thrombectomy or CDT/other catheter directed therapy), or placement of a non-retrieved inferior vena cava filter 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 of CTEPH based on pre-existing clinical findings and combinations of signs of PE chronicity on echocardiography and/or CTPA.
9. Known hypersensitivity to systemic thrombolysis, heparin, or to any of the excipients
10. If, in the Investigator's opinion, or after consultation with the local PERT-team or EC-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 in this study
14. Previous enrolment in this study
15. Refusal of deferred consent by the next of kin or by the patient himself to use the data. Deferred consent will not be asked to relatives of patients who die in scene, but are included in the study.

Where this trial is running

Leiden, South Holland

• Leiden University Medical Centre — Leiden, South Holland, Netherlands (Recruiting)

Study contacts

• Principal investigator: F. A. Klok, Prof. MD. PhD. — Leiden University Medical Center
• Study coordinator: W. J.E. Stenger, MD

Conditions Pulmonary Embolism Acute; Acute Pulmonary Embolism; Full dose systemic thrombolysis; Catheter-directed thrombectomy