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

Recruiting now · Not applicable

Conditions studied: Heart Failure, Revascularization

In brief

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.

Key facts

Study ID: NCT05532631
Run by: Assistance Publique - Hôpitaux de Paris
People needed: 1040
Starts: 2023-03-16
Expected to finish: 2033-07-16
Last updated by the study team: 2023-03-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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)

Where it is running

Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR — Créteil, Val De Marne, France (enrolling)

Full record on ClinicalTrials.gov

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