NCT05532631
Percutaneous Coronary RevascularizatiOn VERsus Coronary-Artery Bypass Grafting for Multivessel Disease in Patients With Left Ventricular Dysfunction (PROVERB)
Recruiting · Not Applicable · Assistance Publique - Hôpitaux de Paris · registry updated 2023-03-22
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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%)....
Inclusion
- 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)
Exclusion
- 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