Comparing two methods for heart revascularization in patients with heart failure
Percutaneous Coronary RevascularizatiOn VERsus Coronary-Artery Bypass Grafting for Multivessel Disease in Patients With Left Ventricular Dysfunction (PROVERB)
This study is testing whether a less invasive heart procedure or a more traditional surgery works better for people with heart failure caused by blocked arteries.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1040 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Créteil, Val De Marne) |
| Trial ID | NCT05532631 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of percutaneous coronary intervention (PCI) versus coronary artery bypass grafting (CABG) in patients with multivessel coronary artery disease and left ventricular dysfunction. Patients will be randomly assigned to receive either PCI with drug-eluting stents or CABG, with both groups receiving optimal medical therapy for heart failure. The study aims to determine which revascularization strategy provides better outcomes for patients suffering from ischemic cardiomyopathy. Follow-up assessments will occur at multiple intervals over three years to monitor patient health and recovery.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a left ventricular ejection fraction of 35% or less and multivessel coronary artery disease suitable for revascularization.
Not a fit: Patients who have had prior coronary interventions within the last six months or those with a history of CABG are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the most effective revascularization strategy for patients with heart failure, potentially improving their quality of life and survival rates.
How similar studies have performed: While there have been retrospective studies on this topic, this is one of the first randomized trials specifically comparing PCI and CABG in this patient population.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Créteil, Val De Marne
- Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR — Créteil, Val De Marne, France (Recruiting)
Study contacts
- Principal investigator: Romain GALLET, MD, PhD — Assistance Publique Hôpitaux de Paris- CHU Henri-Mondor
- Study coordinator: Romain GALLET, MD, PhD
- Email: romain.gallet@aphp.fr
- Phone: 149812111 (Ext: 36771)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.