Clinical trial NCT05532631: Percutaneous Coronary RevascularizatiOn VERsus Coronary-Artery Bypass Grafting for Multivessel Disease in Patients With Left Ventricular Dysfunction (PROVERB)
Official title: Percutaneous Coronary RevascularizatiOn VERsus Coronary-Artery Bypass Grafting for Multivessel Disease in Patients With Left Ventricular Dysfunction (PROVERB)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure
Revascularization
Keywords: Heart Failure
Multi-vessel disease
coronary artery bypass grafting
percutaeous coronary intervention
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2022-09-08
Enrollment: 1040
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective Randomized Open label, Blinded Endpoint, parallelgroup, active controlled, non-inferiority, multicenter trial
Primary purpose: TREATMENT

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).

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)

Primary outcomes:
measure: MACE
timeFrame: 3 years
measure: MACE
timeFrame: 4 years
measure: MACE
timeFrame: 2 years
measure: MACE
timeFrame: 1 year
measure: MACE
timeFrame: 3 months
measure: MACCE
timeFrame: an average of 54 months
Secondary outcomes:
measure: Death
timeFrame: an average of 54 months
measure: Stroke
timeFrame: an average of 54 months
measure: Myocardial Infarction
timeFrame: assessed up to 54 months
measure: Unplanned hospitalization
timeFrame: an average of 54 months
measure: Ischemia driven revascularization
timeFrame: an average of 54 months
measure: Left ventricle ejection fraction
timeFrame: 1 year
measure: Heart Failure Questionnaire
timeFrame: 1 year
measure: Treatment Burden Questionnaire
timeFrame: 1 year
measure: Economic evaluation
timeFrame: an average of 54 months
Other outcomes:
Locations:
city: Créteil
country: France
facility: Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR
state: Val De Marne
Study officials:
affiliation: Assistance Publique Hôpitaux de Paris- CHU Henri-Mondor
name: Akim SOUAG
role: STUDY_CHAIR
affiliation: Assistance Publique Hôpitaux de Paris- CHU Henri-Mondor
name: Romain GALLET, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: