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Percutaneous Coronary RevascularizatiOn VERsus Coronary-Artery Bypass Grafting for Multivessel Disease in Patients With Left Ventricular Dysfunction (PROVERB) (PROVERB)

Primary Purpose

Heart Failure, Revascularization

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Percutaneous coronary intervention
Coronary artery bypass grafting
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Heart Failure, Multi-vessel disease, coronary artery bypass grafting, percutaeous coronary intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥18 years
  • Left ventricle ejection fraction ≤35% measured by echocardiography, cardiac magnetic resonance imaging ventriculogram or gated Single Photon Emission Computed Tomography ventriculogram
  • Multivessel disease suitable for revascularization:

    • Three vessel disease
    • Two vessel disease involving left main or proximal left anterior descending artery
  • Clinical and anatomic eligibility for both percutaneous coronary intervention (PCI) and Coronary artery bypass grafting (CABG) as agreed to by the local Heart Team (interventionalist determines PCI appropriateness and eligibility; cardiac surgeon determines surgical appropriateness and eligibility)
  • Ability to sign informed consent and comply with all study procedures, including follow-up for at least two years
  • Affiliation to health insurance

Exclusion Criteria:

  • Prior:

    • PCI of any coronary artery lesions within 6 months prior to randomization
    • CABG at any time prior to randomization
  • Ongoing cardiogenic shock at the time of coronary angiogram (SBP< 90 mmHg with clinical signs of low output or patients requiring inotropic agents)
  • Contra indication for PCI or CABG determined by the heart team
  • Indication for another cardiac surgery (i.e. valvular surgery, aortic repair…) if CABG is performed
  • ST elevation myocardial infarction < 30 days
  • Non-cardiac illness with a life expectancy of less than 24 months
  • Current participation in other investigational drug or device studies
  • Women who are pregnant or nursing
  • Females of childbearing potential without effective method of birth control
  • Patients who are under tutorship or curatorship
  • Patient on AME (state medical aid)

Sites / Locations

  • Assistance Publique Hôpitaux de Paris - CHU HENRI MONDORRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Angioplasty

Coronary artery bypass grafting

Arm Description

percutaneous coronary angioplasty with drug eluting stent implantation.

Coronary artery bypass grafting has been chosen as the comparator because it is currently the reference strategy for revascularization in patients with multi-vessel disease and heart failure (ESC guidelines). Coronary artery bypass grafting technique will be total arterial revascularization unless internal mammary grafts are unavailable or have inadequate flow. All patients will be treated with anti-thrombotic therapy according to the European Society of Cardiology guidelines.

Outcomes

Primary Outcome Measures

MACE
Comparison of MACE between PCI and CABG. Major adverse cardiac and cerebrovascular events (MACE) is a composite of death from any cause, stroke, myocardial infarction and unplanned hospitalization for heart failure or urgent revascularization.
MACE
Comparison of MACE between PCI and CABG.major adverse cardiac and cerebrovascular events (MACE) is a composite of death from any cause, stroke, myocardial infarction and unplanned hospitalization for heart failure or urgent revascularization.
MACE
Comparison of MACE between PCI and CABG. Major adverse cardiac and cerebrovascular events (MACE) is a composite of death from any cause, stroke, myocardial infarction and unplanned hospitalization for heart failure or urgent revascularization.
MACE
major adverse cardiac and cerebrovascular events (MACE) is a composite of death from any cause, stroke, myocardial infarction and unplanned hospitalization for heart failure or urgent revascularization.
MACE
Comparison of MACE between PCI and CABG
MACCE
The composite outcome of death from any cause, stroke, myocardial infarction, unplanned hospitalization for heart failure or urgent revascularization or ischemia driven revascularization at the end of follow-up

Secondary Outcome Measures

Death
Death from any cause at the end of follow-up
Stroke
Stroke at the end of follow-up
Myocardial Infarction
Myocardial Infarction at the end of follow-up
Unplanned hospitalization
Unplanned hospitalization at the end of follow-up
Ischemia driven revascularization
Ischemia driven revascularization at the end of follow-up
Left ventricle ejection fraction
Left ventricle ejection fraction measure by echocardiography at 1 year
Heart Failure Questionnaire
Health Related Quality of life at 1 year
Treatment Burden Questionnaire
Treatment burden at 1 year (assessed using the Treatment Burden Questionnaire (TBQ))
Economic evaluation
Economic evaluation incremental Cost-utility and cost effectiveness ratios

Full Information

First Posted
January 24, 2022
Last Updated
March 20, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT05532631
Brief Title
Percutaneous Coronary RevascularizatiOn VERsus Coronary-Artery Bypass Grafting for Multivessel Disease in Patients With Left Ventricular Dysfunction (PROVERB)
Acronym
PROVERB
Official Title
Percutaneous Coronary RevascularizatiOn VERsus Coronary-Artery Bypass Grafting for Multivessel Disease in Patients With Left Ventricular Dysfunction (PROVERB)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 16, 2023 (Actual)
Primary Completion Date
July 16, 2030 (Anticipated)
Study Completion Date
July 16, 2033 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A short description, 5000 characters Ischemic cardiomyopathy related to coronary artery disease is currently the leading cause of heart failure. When it is responsible for heart failure, the coronary artery disease likely involves 2 or 3 vessels. Percutaneous coronary angioplasty, which is the other available technique for coronary revascularization, has never been evaluated in this indication. The results of retrospective registries studying the strategy for multivessel revascularization in patients with heart failure are inconsistent and no randomized study has been performed so far. Currently, ESC guidelines recommends to perform coronary-artery bypass grafting (IB) or percutaneous coronary intervention (IIa C) with the acknowledgement that percutaneous coronary intervention has never been properly evaluated in this setting. However, it has been previously demonstrated that left ventricle dysfunction significantly increases mortality and morbidity during and after cardiac surgery (3-10% mortality when LVEF is ≤30%). Moreover, the technical progresses in stent development and manufacturing have led to a dramatic decrease in the incidence of stent thrombosis and in-stent restenosis. Therefore, we hypothesize that percutaneous coronary angioplasty may be an attractive strategy for revascularization in patients with multi-vessel disease and left ventricle dysfunction, who are at high risk of surgical complication. Thus, we aim to test the hypothesis that percutaneous coronary intervention is non-inferior to coronary-artery bypass grafting for revascularization in patients with multivessel disease and left ventricle dysfunction. The main objective is to demonstrate that percutaneous coronary angioplasty is non-inferior to coronary-artery bypass grafting for multivessel revascularization in patients with left ventricular dysfunction on major cardiac and cerebrovascular events (MACCE). Method:A Prospective Randomized Open label, Blinded Endpoint, parallel-group, active controlled, non-inferiority, multicenter trial.
Detailed Description
Patients meeting the selection criteria will be enrolled after providing written informed consent. Patients will be randomized, in a 1:1 ratio, to receive either percutaneous coronary intervention with drug eluting stent or coronary-artery bypass grafting. Whichever technique the patient is randomized to, revascularization will aim to be complete and both techniques will be performed following current guidelines and local practices. No myocardial viability assessment will be mandatory prior to inclusion. Both revascularization strategy will be associated with optimal medical therapy for heart failure. Follow-up will be performed at 3, 12, 24, 36 and for patients enrolled in the trial early in the inclusion period, also at 48 months, and for all patients at the end of the study (3 years after inclusion of the last patient).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Revascularization
Keywords
Heart Failure, Multi-vessel disease, coronary artery bypass grafting, percutaeous coronary intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective Randomized Open label, Blinded Endpoint, parallelgroup, active controlled, non-inferiority, multicenter trial
Masking
Outcomes Assessor
Masking Description
Outcomes Assessor: The individual who evaluates the outcome(s) of interest
Allocation
Randomized
Enrollment
1040 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Angioplasty
Arm Type
Experimental
Arm Description
percutaneous coronary angioplasty with drug eluting stent implantation.
Arm Title
Coronary artery bypass grafting
Arm Type
Active Comparator
Arm Description
Coronary artery bypass grafting has been chosen as the comparator because it is currently the reference strategy for revascularization in patients with multi-vessel disease and heart failure (ESC guidelines). Coronary artery bypass grafting technique will be total arterial revascularization unless internal mammary grafts are unavailable or have inadequate flow. All patients will be treated with anti-thrombotic therapy according to the European Society of Cardiology guidelines.
Intervention Type
Procedure
Intervention Name(s)
Percutaneous coronary intervention
Intervention Description
The studied intervention will be percutaneous coronary angioplasty with drug eluting stent implantation. Percutaneous coronary intervention may be performed during one single procedure or during staged procedures. The decision will be left at the investigator choice. PCI will be performed using drug eluting stent exclusively. The techniques for bifurcation lesions and chronic total occlusion angioplasty will be left at the operator choice. The choice of the drug eluting stent used will be left at the operator's choice. Anti-platelet therapy will be given to all patients randomized to PCI. The choice of the anti-thrombotic regiment and its duration will be left at the investigator choice (after assessment of initial presentation, bleeding and ischemic risks) but will have to comply with the European Society of Cardiology guidelines.
Intervention Type
Procedure
Intervention Name(s)
Coronary artery bypass grafting
Intervention Description
Coronary artery bypass grafting technique will be total arterial revascularization unless internal mammary grafts are unavailable or have inadequate flow. All patients will be treated with anti-thrombotic therapy according to the European Society of Cardiology guidelines
Primary Outcome Measure Information:
Title
MACE
Description
Comparison of MACE between PCI and CABG. Major adverse cardiac and cerebrovascular events (MACE) is a composite of death from any cause, stroke, myocardial infarction and unplanned hospitalization for heart failure or urgent revascularization.
Time Frame
3 years
Title
MACE
Description
Comparison of MACE between PCI and CABG.major adverse cardiac and cerebrovascular events (MACE) is a composite of death from any cause, stroke, myocardial infarction and unplanned hospitalization for heart failure or urgent revascularization.
Time Frame
4 years
Title
MACE
Description
Comparison of MACE between PCI and CABG. Major adverse cardiac and cerebrovascular events (MACE) is a composite of death from any cause, stroke, myocardial infarction and unplanned hospitalization for heart failure or urgent revascularization.
Time Frame
2 years
Title
MACE
Description
major adverse cardiac and cerebrovascular events (MACE) is a composite of death from any cause, stroke, myocardial infarction and unplanned hospitalization for heart failure or urgent revascularization.
Time Frame
1 year
Title
MACE
Description
Comparison of MACE between PCI and CABG
Time Frame
3 months
Title
MACCE
Description
The composite outcome of death from any cause, stroke, myocardial infarction, unplanned hospitalization for heart failure or urgent revascularization or ischemia driven revascularization at the end of follow-up
Time Frame
an average of 54 months
Secondary Outcome Measure Information:
Title
Death
Description
Death from any cause at the end of follow-up
Time Frame
an average of 54 months
Title
Stroke
Description
Stroke at the end of follow-up
Time Frame
an average of 54 months
Title
Myocardial Infarction
Description
Myocardial Infarction at the end of follow-up
Time Frame
assessed up to 54 months
Title
Unplanned hospitalization
Description
Unplanned hospitalization at the end of follow-up
Time Frame
an average of 54 months
Title
Ischemia driven revascularization
Description
Ischemia driven revascularization at the end of follow-up
Time Frame
an average of 54 months
Title
Left ventricle ejection fraction
Description
Left ventricle ejection fraction measure by echocardiography at 1 year
Time Frame
1 year
Title
Heart Failure Questionnaire
Description
Health Related Quality of life at 1 year
Time Frame
1 year
Title
Treatment Burden Questionnaire
Description
Treatment burden at 1 year (assessed using the Treatment Burden Questionnaire (TBQ))
Time Frame
1 year
Title
Economic evaluation
Description
Economic evaluation incremental Cost-utility and cost effectiveness ratios
Time Frame
an average of 54 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥18 years Left ventricle ejection fraction ≤35% measured by echocardiography, cardiac magnetic resonance imaging ventriculogram or gated Single Photon Emission Computed Tomography ventriculogram Multivessel disease suitable for revascularization: Three vessel disease Two vessel disease involving left main or proximal left anterior descending artery Clinical and anatomic eligibility for both percutaneous coronary intervention (PCI) and Coronary artery bypass grafting (CABG) as agreed to by the local Heart Team (interventionalist determines PCI appropriateness and eligibility; cardiac surgeon determines surgical appropriateness and eligibility) Ability to sign informed consent and comply with all study procedures, including follow-up for at least two years Affiliation to health insurance Exclusion Criteria: Prior: PCI of any coronary artery lesions within 6 months prior to randomization CABG at any time prior to randomization Ongoing cardiogenic shock at the time of coronary angiogram (SBP< 90 mmHg with clinical signs of low output or patients requiring inotropic agents) Contra indication for PCI or CABG determined by the heart team Indication for another cardiac surgery (i.e. valvular surgery, aortic repair…) if CABG is performed ST elevation myocardial infarction < 30 days Non-cardiac illness with a life expectancy of less than 24 months Current participation in other investigational drug or device studies Women who are pregnant or nursing Females of childbearing potential without effective method of birth control Patients who are under tutorship or curatorship Patient on AME (state medical aid)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Romain GALLET, MD, PhD
Phone
149812111 (Ext: 36771)
Ext
33
Email
romain.gallet@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Akim SOUAG
Organizational Affiliation
Assistance Publique Hôpitaux de Paris- CHU Henri-Mondor
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Romain GALLET, MD, PhD
Organizational Affiliation
Assistance Publique Hôpitaux de Paris- CHU Henri-Mondor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR
City
Créteil
State/Province
Val De Marne
ZIP/Postal Code
94000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Romain Gallet, PH D
Phone
01 49 81 21 11 (36771)
Ext
33
Email
romain.gallet@aphp.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Percutaneous Coronary RevascularizatiOn VERsus Coronary-Artery Bypass Grafting for Multivessel Disease in Patients With Left Ventricular Dysfunction (PROVERB)

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