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

NCT03218410 | Completed

• 1 other identifier: 183/15
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Pulmonary Embolism (PE)

Keywords

surgical embolectomy; catheter-directed therapy

Outcome Measures

Primary Outcomes (1)

• Difference in RV/LV ratio by contrast-enhanced chest computed tomography

  48-72 hours after surgical embolectomy or catheter therapy

Secondary Outcomes (1)

• Difference in pulmonary occlusion score by contrast-enhanced chest computed tomography

  48-72 hours after surgical embolectomy or catheter therapy

Study Arms (2)

surgical pulmonary embolectomy

ACTIVE COMPARATOR

Procedure: surgical pulmonary embolectomy

catheter-directed thrombolysis

ACTIVE COMPARATOR

Combination Product: catheter-directed thrombolysis

Interventions

surgical pulmonary embolectomy PROCEDURE

surgical pulmonary embolectomy

catheter-directed thrombolysis COMBINATION_PRODUCT

catheter-directed thrombolysis

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Acute symptomatic PE with thrombus located in the pulmonary main trunk or the left and/or right main pulmonary artery
• High-risk PE defined as PE with sustained systemic arterial hypotension (systolic pressure \<90mmHg), cardiogenic shock, or the ongoing need for catecholamine therapy
• Intermediate-high risk PE: Imaging evidence of RV-Dilatation (right-to-left ventricular diameter ratio \>1.0 on echocardiography or chest computed tomography) and biomarker evidence of RV dysfunction (positive Troponin T or I Test).
• The eligibility for both procedures must be established by the PERT team
• Signed Informed consent (by subject or legal representative) -

You may not qualify if:

• Age less than 18 years or greater than 80 years.
• Symptom duration \> 14 days suggesting acute-on-chronic pulmonary embolism.
• Known chronic thromboembolic pulmonary hypertension (CTEPH)
• Suspected chronic thromboembolic pulmonary hypertension (CTEPH) including RV hypertrophy (RV free wall \>5 mm on echocardiography), severe pulmonary hypertension (systolic pulmonary artery pressure \> 80 mmHg on echocardiography), or CT findings suggestive of CTEPH including intraluminal webs, bands, strictures, or eccentric filling defects adjacent to the wall of the pulmonary arteries
• Decompensated cardiogenic shock defined as recent (\<48 hours) cardiopulmonary resuscitation therapy or worsening hemodynamic status despite extended fluid and catecholamine support
• Inability to tolerate catheter procedure or surgical embolectomy due to severe comorbidities.
• Allergy, hypersensitivity, or thrombocytopenia from heparin, r-tPA, or iodinated contrast, except for mild-moderate contrast allergies for which steroid pre-medication can be used.
• Known significant bleeding risk, or known coagulation disorder (including vitamin K antagonists with INR \> 2.0 and platelet count \< 100 000/mm3)
• Severe renal impairment (estimated GFR \< 30 ml/min).
• Active bleeding: recent (\< 3 months) GI bleeding, severe liver dysfunction, bleeding diathesis.
• Recent (\< 3 months) internal eye surgery or hemorrhagic retinopathy; recent (\< 10 days) major surgery, cataract surgery, trauma, CPR, obstetrical delivery, or other invasive procedure.
• History of stroke or intracranial/intraspinal bleed, tumor, vascular malformation, aneurysm.
• Severe hypertension on repeated readings (systolic \> 180 mmHg or diastolic \> 105 mmHg).
• Pregnant, lactation or parturition within the previous 30 days (positive pregnancy test in women of childbearing age)
• Recent (\< 1 month) systemic thrombolysis.

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• University of Bern: collaborator
• Schweizerische Herzstiftung: collaborator

Study Sites (1)

University Hospital Bern

Bern, 3010, Switzerland

Location

Related Publications (4)

• Laporte S, Mismetti P, Decousus H, Uresandi F, Otero R, Lobo JL, Monreal M; RIETE Investigators. Clinical predictors for fatal pulmonary embolism in 15,520 patients with venous thromboembolism: findings from the Registro Informatizado de la Enfermedad TromboEmbolica venosa (RIETE) Registry. Circulation. 2008 Apr 1;117(13):1711-6. doi: 10.1161/CIRCULATIONAHA.107.726232. Epub 2008 Mar 17.

  PMID: 18347212 RESULT

• Silverstein MD, Heit JA, Mohr DN, Petterson TM, O'Fallon WM, Melton LJ 3rd. Trends in the incidence of deep vein thrombosis and pulmonary embolism: a 25-year population-based study. Arch Intern Med. 1998 Mar 23;158(6):585-93. doi: 10.1001/archinte.158.6.585.

  PMID: 9521222 RESULT

• Cohen AT, Agnelli G, Anderson FA, Arcelus JI, Bergqvist D, Brecht JG, Greer IA, Heit JA, Hutchinson JL, Kakkar AK, Mottier D, Oger E, Samama MM, Spannagl M; VTE Impact Assessment Group in Europe (VITAE). Venous thromboembolism (VTE) in Europe. The number of VTE events and associated morbidity and mortality. Thromb Haemost. 2007 Oct;98(4):756-64. doi: 10.1160/TH07-03-0212.

  PMID: 17938798 RESULT

• Kucher N, Rossi E, De Rosa M, Goldhaber SZ. Massive pulmonary embolism. Circulation. 2006 Jan 31;113(4):577-82. doi: 10.1161/CIRCULATIONAHA.105.592592. Epub 2006 Jan 23.

  PMID: 16432055 RESULT

Study Officials

• Lars Englberger, Prof.

  University of Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Monocentric, randomized, open-label, controlled, clinical, non-inferiority trial.

Study Record Dates

• First Submitted: July 13, 2017
• First Posted: July 14, 2017
• Study Start: October 1, 2015
• Primary Completion: June 30, 2020
• Study Completion: December 31, 2020
• Last Updated: November 23, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)