Informations générales (source: ClinicalTrials.gov)
Percutaneous Coronary RevascularizatiOn VERsus Coronary-Artery Bypass Grafting for Multivessel Disease in Patients With Left Ventricular Dysfunction (PROVERB)
Interventional
N/A
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
mars 2023
juillet 2033
18 septembre 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHI ANDRE GREGOIRE | GALLET DE-SAINT-AURIN Romain | 01/11/2025 07:54:20 | Contacter | ||
| HOPITAL MARIE LANNELONGUE | GALLET DE-SAINT-AURIN Romain | 01/11/2025 07:54:20 | Contacter | ||
| INSTITUT MUTUALISTE MONTSOURIS | GALLET DE-SAINT-AURIN Romain | 01/11/2025 07:54:20 | Contacter | ||
| AP-HP Assistance publique - Hôpitaux de Paris | 01/11/2025 07:54:21 | Contacter | |||
| AP-HP - Hôpital Bichat | |||||
| AP-HP - Hôpital Europeen Georges Pompidou | |||||
| AP-HP - Hôpital Henri Mondor-Albert Chenevier | |||||
| AP-HP - Hôpital La Pitié-Salpêtrière | |||||
| AP-HP - Hôpital Lariboisiere-Fernand Widal | |||||
Critères
Tous
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
- 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
- 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)