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

Heart Failure Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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). ;

Related Conditions & MeSH terms

• Heart Failure
• Revascularization
• Ventricular Dysfunction
• Ventricular Dysfunction, Left

• NCT number: NCT05532631
• Study type: Interventional
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Romain GALLET, MD, PhD
• Phone: 149812111 (Ext: 36771)
• Email: romain.gallet@aphp.fr
• Status: Recruiting
• Phase: N/A
• Start date: March 16, 2023
• Completion date: July 16, 2033