Percutaneous Coronary RevascularizatiOn VERsus Coronary-Artery Bypass Grafting for Multivessel Disease in Patients With Left Ventricular Dysfunction (PROVERB) (PROVERB)
Heart Failure, Revascularization
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
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
Experimental
Active Comparator
Angioplasty
Coronary artery bypass grafting
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.