Heart FailurePROVERBNCT05532631
Percutaneous Coronary RevascularizatiOn VERsus Coronary-Artery Bypass Grafting for Multivessel Disease in Patients With Left Ventricular Dysfunction (PROVERB)
A study testing Percutaneous coronary intervention and Coronary artery bypass grafting in people with Heart Failure and Revascularization, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Revascularization
- What is being tested?
- Percutaneous coronary intervention and Coronary artery bypass grafting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,040 participants
- Where
- 1 siteFrance
- Study dates
- 16 Mar 2023to 16 Jul 2033
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR
Créteil, Val De Marne, 94000
Romain Gallet, PH D, 01 49 81 21 11 (36771) ext. 33, romain.gallet@aphp.fr
About this study
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.
Read the detailed 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).
- Conditions
- Heart Failure, Revascularization
- Being tested
- Percutaneous coronary intervention, Coronary artery bypass grafting
- Keywords
- Heart Failure, Multi-vessel disease, coronary artery bypass grafting, percutaeous coronary intervention
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous coronary interventionProcedure or surgery
The studied intervention will be percutaneous coronary angioplasty with drug eluting stent implantation. Percutaneous coronary intervention may be performed during one single procedure or during staged procedures. The decision will be left at the investigator choice. PCI will be performed using drug eluting stent exclusively. The techniques for bifurcation lesions and chronic total occlusion angioplasty will be left at the operator choice. The choice of the drug eluting stent used will be left at the operator's choice. Anti-platelet therapy will be given to all patients randomized to PCI. The choice of the anti-thrombotic regiment and its duration will be left at the investigator choice (after assessment of initial presentation, bleeding and ischemic risks) but will have to comply with the European Society of Cardiology guidelines.
Coronary artery bypass graftingProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Angioplasty | Experimental | percutaneous coronary angioplasty with drug eluting stent implantation. Receives: Procedure: Percutaneous coronary intervention |
| Coronary artery bypass grafting | Active comparator | 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. Receives: Procedure: Coronary artery bypass grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACE
Comparison of MACE between PCI and CABG. Major adverse cardiac and cerebrovascular events (MACE) is a composite of death from any cause, stroke, myocardial infarction and unplanned hospitalization for heart failure or urgent revascularization.
Measured: 3 years
MACE
Comparison of MACE between PCI and CABG.major adverse cardiac and cerebrovascular events (MACE) is a composite of death from any cause, stroke, myocardial infarction and unplanned hospitalization for heart failure or urgent revascularization.
Measured: 4 years
MACE
Comparison of MACE between PCI and CABG. Major adverse cardiac and cerebrovascular events (MACE) is a composite of death from any cause, stroke, myocardial infarction and unplanned hospitalization for heart failure or urgent revascularization.
Measured: 2 years
MACE
major adverse cardiac and cerebrovascular events (MACE) is a composite of death from any cause, stroke, myocardial infarction and unplanned hospitalization for heart failure or urgent revascularization.
Measured: 1 year
MACE
Comparison of MACE between PCI and CABG
Measured: 3 months
MACCE
The composite outcome of death from any cause, stroke, myocardial infarction, unplanned hospitalization for heart failure or urgent revascularization or ischemia driven revascularization at the end of follow-up
Measured: an average of 54 months
Secondary outcomes (9)
Death
Death from any cause at the end of follow-up
Measured: an average of 54 months
Stroke
Stroke at the end of follow-up
Measured: an average of 54 months
Myocardial Infarction
Myocardial Infarction at the end of follow-up
Measured: assessed up to 54 months
Unplanned hospitalization
Unplanned hospitalization at the end of follow-up
Measured: an average of 54 months
Ischemia driven revascularization
Ischemia driven revascularization at the end of follow-up
Measured: an average of 54 months
Left ventricle ejection fraction
Left ventricle ejection fraction measure by echocardiography at 1 year
Measured: 1 year
Heart Failure Questionnaire
Health Related Quality of life at 1 year
Measured: 1 year
Treatment Burden Questionnaire
Treatment burden at 1 year (assessed using the Treatment Burden Questionnaire (TBQ))
Measured: 1 year
Economic evaluation
Economic evaluation incremental Cost-utility and cost effectiveness ratios
Measured: an average of 54 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2022
- Study start16 Mar 2023
- Primary completion16 Jul 2030 (estimated)
- Study completion16 Jul 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective Randomized Open label, Blinded Endpoint, parallelgroup, active controlled, non-inferiority, multicenter trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,040 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Akim SOUAG, Study chair, Assistance Publique Hôpitaux de Paris- CHU Henri-MondorRomain GALLET, MD, PhD, Principal investigator, Assistance Publique Hôpitaux de Paris- CHU Henri-Mondor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05532631
- Sponsor's protocol ID
- APHP211005
- Acronym
- PROVERB
- Status last verified
- Feb 2023
- First submitted
- 24 Jan 2022
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Coronary RevascularizatiOn VERsus Coronary-Artery Bypass Grafting for Multivessel Disease in Patients With Left Ventricular Dysfunction (PROVERB)
- ClinicalTrials.gov ID
- NCT05532631
- Acronym / sponsor ID
- PROVERB / APHP211005
- Conditions
- Heart Failure, Revascularization
- Keywords
- Heart Failure, Multi-vessel disease, coronary artery bypass grafting, percutaeous coronary intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,040 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 16 Mar 2023 (actual)
- Primary completion
- 16 Jul 2030 (estimated)
- Study completion
- 16 Jul 2033 (estimated)
- First posted
- 8 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective Randomized Open label, Blinded Endpoint, parallelgroup, active controlled, non-inferiority, multicenter trial
| Arm | Type | Receives |
|---|---|---|
| Angioplasty | Experimental | Procedure: Percutaneous coronary interventionpercutaneous coronary angioplasty with drug eluting stent implantation. |
| Coronary artery bypass grafting | Active comparator | Procedure: Coronary artery bypass graftingCoronary 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- 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
Key exclusion criteria (13 listed)
- Prior:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous coronary interventionThe studied intervention will be percutaneous coronary angioplasty with drug eluting stent implantation. Percutaneous coronary intervention may be performed during one single procedure or during staged procedures. The decision will be left at the investigator choice. PCI will be performed using drug eluting stent exclusively. The techniques for bifurcation lesions and chronic total occlusion angioplasty will be left at the operator choice. The choice of the drug eluting stent used will be left at the operator's choice. Anti-platelet therapy will be given to all patients randomized to PCI. The choice of the anti-thrombotic regiment and its duration will be left at the investigator choice (after assessment of initial presentation, bleeding and ischemic risks) but will have to comply with the European Society of Cardiology guidelines. | Procedure or surgery | Angioplasty |
| Coronary artery bypass graftingCoronary 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 | Procedure or surgery | Coronary artery bypass grafting |
Primary outcome
MACE
Time frame: 3 years
Comparison of MACE between PCI and CABG. Major adverse cardiac and cerebrovascular events (MACE) is a composite of death from any cause, stroke, myocardial infarction and unplanned hospitalization for heart failure or urgent revascularization.
MACE
Time frame: 4 years
Comparison of MACE between PCI and CABG.major adverse cardiac and cerebrovascular events (MACE) is a composite of death from any cause, stroke, myocardial infarction and unplanned hospitalization for heart failure or urgent revascularization.
MACE
Time frame: 2 years
Comparison of MACE between PCI and CABG. Major adverse cardiac and cerebrovascular events (MACE) is a composite of death from any cause, stroke, myocardial infarction and unplanned hospitalization for heart failure or urgent revascularization.
MACE
Time frame: 1 year
major adverse cardiac and cerebrovascular events (MACE) is a composite of death from any cause, stroke, myocardial infarction and unplanned hospitalization for heart failure or urgent revascularization.
MACE
Time frame: 3 months
Comparison of MACE between PCI and CABG
MACCE
Time frame: an average of 54 months
The composite outcome of death from any cause, stroke, myocardial infarction, unplanned hospitalization for heart failure or urgent revascularization or ischemia driven revascularization at the end of follow-up
9 secondary outcomes
Death
Time frame: an average of 54 months
Stroke
Time frame: an average of 54 months
Myocardial Infarction
Time frame: assessed up to 54 months
Unplanned hospitalization
Time frame: an average of 54 months
Ischemia driven revascularization
Time frame: an average of 54 months
Left ventricle ejection fraction
Time frame: 1 year
Heart Failure Questionnaire
Time frame: 1 year
Treatment Burden Questionnaire
Time frame: 1 year
Economic evaluation
Time frame: an average of 54 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Akim SOUAG study chair
Assistance Publique Hôpitaux de Paris- CHU Henri-Mondor
Romain GALLET, MD, PhD principal investigator
Assistance Publique Hôpitaux de Paris- CHU Henri-Mondor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous coronary intervention and Coronary artery bypass grafting in people with Heart Failure and Revascularization, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Romain GALLET, MD, PhD (149812111 (Ext: 36771) ext. 33, romain.gallet@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MACE (time frame: 3 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2023.