Short-term Outcomes of Elective High-risk PCI With Extracorporeal Membrane Oxygenation Support: a Single-centre Registry

May 20, 2022 updated by: Robert Jan van Geuns

Background Revascularization of complex coronary artery disease, including multivessel coronary artery disease, left main stenosis, bifurcation stenosis and chronic total occlusions (CTO) can be performed by Percutaneous Coronary Intervention (PCI) or Coronary Artery Bypass Graft (CABG), according to current guidelines.[1] In order to decide whether to revascularize by either CABG or PCI, patient characteristics, the presence of comorbidities, including diabetes, and coronary lesion complexity (e.g. SYNTAX) should be taken into consideration. Because of the ageing population with a higher incidence of comorbidities and higher surgical risk scores, high-risk PCI in complex coronary disease with high risk for periprocedural cardiogenic shock is increasingly performed.[2, 3] Mechanical Circulatory Support (MCS) devices for elective high-risk PCI can provide hemodynamic support, preventing hemodynamic failure during PCI. Several studies are performed using Intra-Aortic Balloon Pump (IABP) and co-axial left cardiac support device (Impella device (Abiomed, Danvers, USA)), showing no clear benefits in patients with high-risk PCI.[4-6] Veno-Arterial Extracorporeal Membrane Oxygenation (VA-ECMO) is a recent addition to mechanical support options, providing more extensive hemodynamic support in patients with potential or ongoing failure of circulation. This concept is already demonstrated in the setting of Extracorporeal Cardiopulmonary Resuscitation (ECPR).[7, 8] ECMO has the additional benefits of right ventricular unloading and blood oxygenation as opposed to IABP and Impella.[9] Our experience with fully percutaneous VA-ECMO in cardiogenic shock and for ECPR combined with the experience for Transcatheter Aortic Valve Replacement (TAVR) with local anaesthesia and mild sedation resulted in the selection of VA-ECMO as our preferred method in high risk PCI. Studies investigating the use of VA-ECMO support during high-risk PCI are however limited.[10-13]

Objective The aim of this study is to provide additional data concerning the short-term outcomes of elective high-risk PCI with VA-ECMO in a single PCI centre.

Methods Design We will perform a single-centre, retrospective registry, using data collected from medical records of included patients.

Inclusion criteria

  • Patients older than 18 years, who underwent high-risk PCI with VA-ECMO support.
  • The use of mechanical circulatory support (MCS) is indicated by HeartTeam based on patient and lesion characteristics described in the expert consensus on the use of MCS Devices for high-risk PCI. [14]

Exclusion criteria

• Non-elective PCI with VA-ECMO support, primarily applied for cardiogenic shock or ECPR.

Study Procedures All patients older than 18 years who underwent high-risk PCI with VA-ECMO support will be included in the registry. Baseline patient and angiographic characteristics, ECMO characteristics and short-term outcomes, described in the paragraph 'Study Endpoints and Definitions' will be collected from medical records.

The Dutch Act on Medical Research involving Human Subjects (WMO) does not apply to this study, because of the retrospective design of the study using only medical records and consequently patients are not subjected to additional procedures. Therefore, no written informed consent will be obtained from patients or legal representatives as well.

Data Collection All data will be collected in a cloud-based electronic case report form (eCRF, Castor Electronic Data Capture), which will be developed and managed by investigators in the Radboudumc. Only members of the study team will have access to the patient eCRFs and will be allowed to enter data in the system. The study team exists of the investigators mentioned earlier. The study team will collect the data from medical records and enter the data in Castor. All patient data will be encoded. Only the investigators involved will have access to the patient identification key.

Study Endpoints and Definitions Successful revascularization is defined as final residual stenosis <50% with a TIMI flow grade 3, achieved in at least one of the target vessels. Procedural success is defined as angiographic success without the occurrence of peri-procedural MACE, including death and myocardial infarction (MI). Additionally, MACE will be assessed during hospital stay and within 60-days follow-up after discharge and defined as a composite of death, MI, Target Vessel Revascularization (TVR) by PCI or CABG and clinical bleeding, assessed by the Bleeding Academic Research Consortium (BARC) scale. Bleeding complications of type 2 and higher are included.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Nijmegen, Netherlands
        • Radboud University Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients older than 18 years who are undergoing a high-risk PCI with VA-ECMO support, indicated by HeartTeam consensus based on patient and lesion characteristics, as described by the expert consensus. If a non-elective PCI with VA-ECMO support, primarily applied for cardiogenic shock or ECPR, is performed, patients are not eligible for inclusion.

Description

Inclusion Criteria:

  • Patients older than 18 years, who underwent high-risk PCI with VA-ECMO support.
  • The use of mechanical circulatory support (MCS) is indicated by HeartTeam based on patient and lesion characteristics described in the expert consensus on the use of MCS Devices for high-risk PCI.

Exclusion Criteria:

- Non-elective PCI with VA-ECMO support, primarily applied for cardiogenic shock or ECPR.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ECMO
Patients receiving hemodynamic support with ECMO during high-risk PCI
Device: Extracorporeal Membrane Oxygenation
Patients with high-risk PCI receive mechanical circulatory support with ECMO.
ECMO Standby
Patients with ECMO standby during high-risk PCI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major Adverse Cardiac Events
Time Frame: from PCI procedure up to hospital discharge, an average of 7 days
Composite of death, MI, Target Vessel Revascularization (TVR) by PCI or CABG and clinical bleeding, assessed by the Bleeding Academic Research Consortium (BARC) scale
from PCI procedure up to hospital discharge, an average of 7 days
Major Adverse Cardiac Events
Time Frame: within 60 days after discharge
Composite of death, MI, Target Vessel Revascularization (TVR) by PCI or CABG
within 60 days after discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Succesful Revascularization
Time Frame: During PCI Procedure
Final residual stenosis <50% with a TIMI flow grade 3, achieved in at least one of the target vessels
During PCI Procedure
Procedural Success
Time Frame: During PCI Procedure
Angiographic success without the occurrence of peri-procedural MACE, including death and myocardial infarction (MI)
During PCI Procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Robert Jan van Geuns

Investigators

  • Principal Investigator: Robert Jan M van Geuns, Prof. dr., Radboud University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 3, 2022

Primary Completion (Actual)

February 8, 2022

Study Completion (Actual)

March 22, 2022

Study Registration Dates

First Submitted

May 16, 2022

First Submitted That Met QC Criteria

May 20, 2022

First Posted (Actual)

May 24, 2022

Study Record Updates

Last Update Posted (Actual)

May 24, 2022

Last Update Submitted That Met QC Criteria

May 20, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 113382

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Upon request, data supporting the findings and conclusion of this study will be made available by the PI.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Coronary Artery Disease

Clinical Trials on Extracorporeal Membrane Oxygenation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Vietnam

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe