Catheter-directed Thrombectomy in High and Intermediate-high Risk Pulmonary Embolism

• Conditions: Pulmonary Embolism With Acute Cor Pulmonale
• Interventions: Device: Catheter-directed thrombectomy

• Registration Number: NCT04473560
• Lead Sponsor: Poznan University of Medical Sciences

Brief Summary

Pulmonary embolism is one of the leading causes of cardiovascular death. Pulmonary embolism may be life-threatening condition with an estimated 30-day mortality rate about 10-30%. In high-risk pulmonary embolism, systemic thrombolysis is indicated, whereas recent development of interventional cardiology has made catheter-directed techniques an important alternative to thrombolytic therapy. The controversy concerns also risk stratification and treatment in intermediate-high risk pulmonary embolism patients. A significant percentage of intermediate-high risk patients with pulmonary embolism may experience rapid hemodynamic deterioration and then the prognosis in this group is significantly worse. Catheter-directed techniques are aimed to quickly relive obstruction and restore pulmonary blood flow, thus increasing cardiac output and immediately restoring hemodynamic stability.

The scope of this study is to evaluate the safety and feasibility of catheter-directed approaches in high-risk and intermediate-high risk pulmonary embolism patients.

Detailed Description

Pulmonary embolism is one of the leading causes of cardiovascular death. Pulmonary embolism may be life-threatening condition with an estimated 30-day mortality rate about 10-30%. In high-risk pulmonary embolism, systemic thrombolysis is indicated, whereas recent development of interventional cardiology has made catheter-directed techniques an important alternative to thrombolytic therapy. The controversy concerns also risk stratification and treatment in intermediate-high risk pulmonary embolism patients. A significant percentage of intermediate-high risk patients with pulmonary embolism may experience rapid hemodynamic deterioration and then the prognosis in this group is significantly worse. Catheter-directed techniques are aimed to quickly relive obstruction and restore pulmonary blood flow, thus increasing cardiac output and immediately restoring hemodynamic stability.

The scope of this study is to evaluate the safety and feasibility of catheter-directed approaches in high-risk and intermediate-high risk pulmonary embolism patients.

The primary data recorded include details of each patient's clinical status, co-morbidities with the Charlson Comorbidity Index, the implemented catheter-directed therapy, the results of additional studies (lab tests results, electrocardiogram, imaging studies), and the outcome. The study endpoints comprise technical success, clinically relevant procedure-related complications or bleeding events, classified according to the Valve Academic Research Consortium-2 guidelines criteria.

Collecting the fore mentioned data allows for clinicians to better manage the pulmonary embolism patients with increased mortality risk.

Study Timeline

• Study Start: 2018-10-01
• Study First Submitted: 2020-07-06
• Study First Submitted QC: 2020-07-15
• Study First Posted: 2020-07-16
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-14
• Last Update Posted: 2020-08-18
• Primary Completion: 2022-09-30
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Clinical symptoms and presentation consistent with pulmonary embolism (PE).

2. PE symptoms duration ≤ 14 days.

3. High risk PE patients with absolute contraindications to systemic thrombolysis or its failure (refractory circulatory collapse) not eligible for surgical embolectomy.

4. Intermediate-high risk PE patients with right ventricle dysfunction confirmed by computed tomography pulmonary angiography or transthoracic echocardiography and elevated troponin level with concomitant at least one of below criterium for minimum 24 hours:

   1. Systolic blood pressure > 90 mmHg and ≤ 100 mmHg
   2. Heart rate ≥ 110/min,
   3. Arterial blood saturation <90% during spontaneous breathing (atm)

5. Intermediate-high risk PE patients with right ventricle dysfunction confirmed by computed tomography pulmonary angiography or transthoracic echocardiography and elevated troponin level with sudden occurrence of one or more of the below listed factors:

   1. Systolic blood pressure > 90 mmHg and ≤ 100 mmHg
   2. Heart rate≥ 110/min,
   3. Arterial blood saturation <90% during spontaneous breathing (atm)

Exclusion Criteria

1. Pregnancy.
2. Refusal to sign the informed consent form.
3. Presence of intracardiac thrombus.
4. Diagnosed thrombophilia.
5. Severe thrombocytopenia (platelets count below 20 000 µL).
6. History of severe or chronic pulmonary hypertension.
7. Serum creatinine level higher than 1.8 mg/dl.
8. Known serious and uncontrolled sensitivity to radiographic agents.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Catheter-directed thrombectomy group	Catheter-directed thrombectomy	Patients with acute pulmonary embolism treated with catheter-directed thrombectomy along with anticoagulation therapy

Primary Outcome Measures

Name	Time	Method
Early mortality rate from pulmonary embolism	24 hours after catheter-directed thrombectomy	Number of patients who died from pulmonary embolism (right heart failure) during the first 24 hours after CDT.
Reduction of vascular obstruction	Immediately after catheter-directed thrombectomy procedure	Incidence of the at least 50% reduction of vascular obstruction in the angiography assessed with Miller Index score
Ventricular strain reduction	24 hours after catheter-directed thrombectomy	Rate of right ventricular strain reduction (right ventricle/left ventricle ratio assessment) in echocardiography 24 hours after the CDT.
Clinical improvement during catheter-directed thrombectomy (CDT) procedure	Immediately after catheter-directed thrombectomy procedure	Incidence of arterial blood saturation increase \>92%
Reduction of pulmonary arterial pressures	Immediately after catheter-directed thrombectomy procedure	Incidence of the reduction of systolic and mean pulmonary arterial pressures (mmHg) more than 10% immediately after CDT procedure.

Secondary Outcome Measures

Name	Time	Method
Total mortality rate from pulmonary embolism	3 months after catheter-directed thrombectomy	1. Number of patients who died from pulmonary embolism (right heart failure)
Bleeding events incidence	3 months after catheter-directed thrombectomy	Incidence of major bleedings assessed using The Valve Academic Research Consortium-2 criteria
Adverse events incidence	3 months after catheter-directed thrombectomy	Incidence of pulmonary vascular injury assessed on angiography

Trial Locations

Locations (1)

Poznan University of Medical Sciences; 🇵🇱 Poznan, Greaterpoland, Poland