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

NCT05532631 | Recruiting DMC

• 1 other identifier: APHP211005
• Study Type: interventional
• Target: 1,040
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Revascularization

Keywords

Heart Failure; Multi-vessel disease; coronary artery bypass grafting; percutaeous coronary intervention

Outcome Measures

Primary Outcomes (6)

• 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.

  3 years

• 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.

  4 years

• 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.

  2 years

• 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.

  1 year

• MACE

  Comparison of MACE between PCI and CABG

  3 months

• 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

  an average of 54 months

Secondary Outcomes (9)

• Death

  an average of 54 months

• Stroke

  an average of 54 months

• Myocardial Infarction

  assessed up to 54 months

• Unplanned hospitalization

  an average of 54 months

• Ischemia driven revascularization

  an average of 54 months

Study Arms (2)

Angioplasty

EXPERIMENTAL

percutaneous coronary angioplasty with drug eluting stent implantation.

Procedure: Percutaneous coronary intervention

Coronary artery bypass grafting

ACTIVE COMPARATOR

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.

Procedure: Coronary artery bypass grafting

Interventions

Percutaneous coronary intervention PROCEDURE

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.

Angioplasty

Coronary artery bypass grafting PROCEDURE

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

Coronary artery bypass grafting

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR

Créteil, Val De Marne, 94000, France

RECRUITING

MeSH Terms

Conditions

Heart Failure

Interventions

Percutaneous Coronary Intervention; Coronary Artery Bypass

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Myocardial Revascularization; Cardiac Surgical Procedures; Vascular Grafting; Thoracic Surgical Procedures

Study Officials

• Akim SOUAG

  Assistance Publique Hôpitaux de Paris- CHU Henri-Mondor

  STUDY CHAIR

• Romain GALLET, MD, PhD

  Assistance Publique Hôpitaux de Paris- CHU Henri-Mondor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Romain GALLET, MD, PhD

CONTACT

149812111 (Ext: 36771); romain.gallet@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes Assessor: The individual who evaluates the outcome(s) of interest
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective Randomized Open label, Blinded Endpoint, parallelgroup, active controlled, non-inferiority, multicenter trial

Study Record Dates

• First Submitted: January 24, 2022
• First Posted: September 8, 2022
• Study Start: March 16, 2023
• Primary Completion (Estimated): July 16, 2030
• Study Completion (Estimated): July 16, 2033
• Last Updated: March 22, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)