Myocardial Hybrid Revascularization Versus Coronary artERy Bypass GraftING for Complex Triple-vessel Disease

Study Overview
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Brief Summary
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This is a pilot randomized study that aim to assess the safety and feasibility of a hybrid myocardial revascularization strategy (coronary artery by-pass graft and percutaneous intervention) in comparison with conventional surgical coronary bypass grafting.

Official Title
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Myocardial Hybrid Revascularization Versus Coronary artERy Bypass GraftING for Complex Triple-vessel Disease

Conditions
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Multivessel Coronary Artery Disease

Intervention / Treatment
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* Procedure: Hybrid Revascularization
* Procedure: Conventional Coronary Artery Bypass Surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Triple-vessel disease with proximal or mid LAD disease with angiographic diameter stenosis > 70% by visual analysis in all three territories, requiring myocardial revascularization OR triple-vessel disease with proximal or mid LAD disease with angiographic diameter stenosis 50-70% by visual analysis in any territory but with invasive or non-invasive evidence of flow-limiting stenosis in all three territories, requiring myocardial revascularization Total SYNTAX score > 22 LCx and RCA territories estimated to be equivalently revascularized by either PCI or CABG, with at least one major non-LAD vessel to be treated Clinical and anatomic eligibility for both PCI and CABG as agreed to by both interventional and surgical consensus Interventionalist determines PCI appropriateness and eligibility Surgeon determines surgical appropriateness and eligibility Silent ischemia, stable angina, unstable angina or recent MI If recent MI, cardiac biomarkers must have returned to normal prior to randomization Ability to sign informed consent and comply with all study procedures Exclusion Criteria: Prior PCI or CABG at any time prior to randomization Need for any concomitant cardiac surgery other than CABG (e.g. valve surgery, aortic repair, etc.), or intent that if the patient randomizes to surgery, any cardiac surgical procedure other than isolated CABG will be performed Patients unable to tolerate, obtain or comply with dual antiplatelet therapy for at least one year Patients requiring additional surgery (cardiac or non cardiac) within one year The presence of any clinical or anatomical condition(s) which leads the participating interventional cardiologist to believe that clinical equipoise is not present (i.e. the patient should not be treated by PCI, but rather should be managed with CABG or medical therapy - reasons will be documented) The presence of any clinical or anatomical condition(s) which leads the participating cardiac surgeon to believe that clinical equipoise is not present (i.e. the patient should not be treated by CABG, but rather should be managed with PCI. or medical therapy - reasons will be documented) Non cardiac co-morbidities with life expectancy less than 1 year Other investigational drug or device studies that have not reached their primary endpoint.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hybrid Revascularization<br>The hybrid myocardial revascularization group will be accomplished by a two-step scheme, comprised by off-pump LIMA-to-left anterior descending grafting, followed by percutaneous coronary interventions with Promus Element (everolimus second generation drug eluting stent) for the remaining coronary lesions. | Procedure: Hybrid Revascularization<br>* Off-pump LIMA connected to the left anterior descending artery followed by percutaneous coronary intervention with drug eluting stents to the other territories.<br>|
| Other: Conventional Surgical Coronary Bypass Grafting<br>Conventional Coronary Artery Bypass Grafts with in pump technique. | Procedure: Conventional Coronary Artery Bypass Surgery<br>* On pump coronary artery by-pass surgery<br>* Other names: Surgery;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of Revascularization Procedure Proposed by the Heart Team | The primary endpoint of this pilot study is the feasibility of revascularization planned preoperatively by the Heart team in the absence of adverse events (death, myocardial infarction, stroke, or unplanned revascularization) at 30 days. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Cardiovascular Events | Composite and isolated measure of adverse events (all-cause death, myocardial infarction, stroke, or unplanned revascularization) at 1 year and annually up to 5 years. | 1 year | 
| Major Adverse Cardiovascular Events | Composite and isolated measure of adverse events (all-cause death, myocardial infarction, stroke, or unplanned revascularization) at 1 year and annually up to 5 years. | 2 years | 
| Major Adverse Cardiovascular Events | Composite and isolated measure of adverse events (all-cause death, myocardial infarction, stroke, or unplanned revascularization) at 1 year and annually up to 5 years. | 3 years | 
| Major Adverse Cardiovascular Events | Composite and isolated measure of adverse events (all-cause death, myocardial infarction, stroke, or unplanned revascularization) at 1 year and annually up to 5 years. | 4 years | 
| Major Adverse Cardiovascular Events | Composite and isolated measure of adverse events (all-cause death, myocardial infarction, stroke, or unplanned revascularization) at 1 year and annually up to 5 years. | 5 years | 
| Major Adverse Cardiovascular Events | Composite and isolated measure of adverse events (all-cause death, myocardial infarction, stroke, or unplanned revascularization) at 1 year and annually up to 5 years. | 180 days | 
| Safety | Cause of death (cardiac vs. non-cardiac); MI type; stroke type and severity. | 1 year | 
| Recurrence of Angina | Analyse patient recurrence of angina according to the Canadian Cardiovascular Society (CCS) | 1 year | 
| Medication Impact | Impact of antithrombotic agents and dual antiplatelet therapy in peri-procedural and long-term follow up safety end points. | 1 year | 
| Stent Thrombosis | Evaluate stent thrombosis according to the ARC (Academic Research Consortium) criteria | 1 year | 
| Bleeding | Hemorrhagic complications according to the BARC (Bleeding Academic Research Consortium) criteria | 1 year | 
| Neurological Events | Evaluate neurological complications by clinical tests (physical examination), vascular ultrasound and doppler perfusion measures. | 1 year | 
| Graft Patency | Patency of grafts and coronary artery disease at 1 year of follow-up evaluated by angiotomography | 1 year | 
| Clinical and Angiographic Scores Correlation with Prognostic | Evaluate the clinical correlation between the revascularization strategy and the usefulness of the SYNTAX score, ACEF score, clinical SYNTAX score, logistic EuroSCORE, STS score and InsCor for prognostic evaluation | 1 year | 
| Efficacy of the Strategy | Evaluate and compare the rate of repeated revascularization (target lesions and target vessels) in each one of both strategies. | 1 year | 
| Symptomatic Graft Occlusion | Evaluate patients that presented with recurrent ischaemia symptoms due to graft occlusion. The diagnostic must be done by angiography or angiotomography. | 1 Year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multivessel Coronary Artery Disease, Hybrid Revascularization