NCT03218410: Lungembolism

Surgical Pulmonary Embolectomy Versus Catheter-directed Thrombolysis in the Treatment of Pulmonary Embolism: A Non-inferiority Study

Completed NA Last updated 23 November 2021

What this trial tests

NA trial testing surgical pulmonary embolectomy in Acute Pulmonary Embolism (PE) in 60 participants. Completed in 31 December 2020.

Timeline

1 October 2015

Primary endpoint
30 June 2020

31 December 2020

Quick facts

Lead sponsor	Insel Gruppe AG, University Hospital Bern
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	60
Start date	1 October 2015
Primary completion	30 June 2020
Estimated completion	31 December 2020
Sites	1 location across Switzerland

Drugs / interventions tested

• surgical pulmonary embolectomy
• catheter-directed thrombolysis

Conditions studied

• Acute Pulmonary Embolism (PE) — all drugs for Acute Pulmonary Embolism (PE) →

Sponsor

Insel Gruppe AG, University Hospital Bern

Who can join

Adults 18 to 80, any sex, with Acute Pulmonary Embolism (PE). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Acute pulmonary embolism (PE) is a serious and potentially lethal condition. The clinical spectrum of PE spans from asymptomatic PE to patients with severe hemodynamic compromise. The main determinant of outcome is right ventricular dysfunction caused by the abrupt rise in pulmonary vascular resistance. Patients with hemodynamic compromise are at highest risk of mortality (\>15%). Hemodynamic stable patients with imaging and biomarker evidence of right ventricular (RV)- dysfunction are at intermediate-high risk of mortality (3-15%). According to the European Society of Cardiology (ESC) guidelines reperfusion therapy options for patients at high risk and at intermediate-high risk include systemic thrombolysis, catheter-directed therapy or surgical embolectomy.

The University Hospital of Bern is the only tertiary care hospital in Switzerland that has established an interdisciplinary pulmonary embolism response team (PERT since 2010) and has gained expertise in both catheter-directed thrombolysis and surgical embolectomy. Since the introduction of PERT, systemic thrombolysis was no longer performed in Bern due to the high risk of intracranial hemorrhage. Favorable clinical outcomes of the patients managed in Bern have been published for both catheter-directed therapy and surgical embolectomy.

To date, no study has ever compared catheter-directed thrombolysis versus surgical pulmonary embolectomy in the treatment of high and intermediate-high risk PE patients.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Percutaneous treatment options for acute pulmonary embolism: a clinical consensus statement by the ESC Working Group on Pulmonary Circulation and Right Ventricular Function and the European Association of Percutaneous Cardiovascular Interventions.
   Pruszczyk P, Klok FA, Kucher N, Roik M, et al · · 2022 · cited 146× · PMID 36112184 · DOI 10.4244/eij-d-22-00246
2. Thrombolytic therapy for pulmonary embolism.
   Zuo Z, Yue J, Dong BR, Wu T, et al · · 2021 · cited 27× · PMID 33857326 · DOI 10.1002/14651858.cd004437.pub6
3. Percutaneous interventions for pulmonary embolism.
   Finocchiaro S, Mauro MS, Rochira C, Spagnolo M, et al · · 2024 · cited 26× · PMID 38562073 · DOI 10.4244/eij-d-23-00895
4. Catheter-directed therapies for the treatment of high risk (massive) and intermediate risk (submassive) acute pulmonary embolism.
   Harvey JJ, Huang S, Uberoi R. · · 2022 · cited 26× · PMID 35938605 · DOI 10.1002/14651858.cd013083.pub2
5. Thrombolytic therapy for pulmonary embolism.
   Hao Q, Dong BR, Yue J, Wu T, et al · · 2018 · cited 22× · PMID 30560579 · DOI 10.1002/14651858.cd004437.pub5
6. Catheter-based interventions versus medical and surgical approaches in acute pulmonary embolism.
   Cires-Drouet RS, Nagarsheth K, Kaczorowski DJ, Toursavadkohi S, et al · · 2021 · cited 4× · PMID 33965609 · DOI 10.1016/j.jvsv.2021.02.015