Safety and Efficacy Study of Hybrid Revascularization in Multivessel Coronary Artery Disease

Study Overview
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Brief Summary
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The purpose of the study is to assess the safety and efficacy of hybrid revascularization in comparison with coronary artery bypass grafting among patients with multivessel coronary artery disease.

Official Title
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Prospective Randomised Pilot Study Evaluating the Safety and Efficacy of Hybrid Revascularization in Multivessel Coronary Artery Disease

Conditions
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Heart Disease, Myocardial Ischaemia, Coronary Disease, Coronary Artery Disease

Intervention / Treatment
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* Procedure: Hybrid revascularization
* Procedure: Coronary Artery Bypass Grafting


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 or more Angiographically confirmed multivessel CAD with involved LAD and critical (>70%)lesion in at least one (apart LAD) major epicardial vessel amenable to both PCI and CABG Indication for revascularization based upon symptoms of angina and/or objective evidence of myocardial ischaemia Patient is willing to comply with all follow-up visits Patient signed an Informed Consent Exclusion Criteria: Severe congestive heart failure (class III or IV according to NYHA, or pulmonary edema, cardiogenic shock) at the time of enrollment Prior surgery with the opening of pericardium or pleura Prior stroke (within 6 months)or more than 6 months if there are substantial neurological defects Prior history of significant bleeding (within previous 6 months) that might be expected to occur during PCI/CABG related anticoagulation One or more chronic total occlusions in major coronary territories Left main stenosis (at least 50% diameter stenosis) Acute ST-elevation MI within 72 hours prior to enrollment requiring revascularization Planned simultaneous surgical procedure unrelated to coronary revascularization (e.g. valve repair/replacement, aneurysmectomy, carotid endarterectomy or carotid stenting) Contraindication to either CABG, MIDCAB or PCI/DES because of a coexisting clinical condition Significant leukopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis. Intolerance or contraindication to aspirin or both clopidogrel and ticlopidine Extra-cardiac illness that is expected to limit survival to less than 5 years e.g. oxygen-dependent chronic obstructive pulmonary disease, active hepatitis or significant hepatic failure, severe renal disease Suspected pregnancy. A pregnancy test will be administered prerandomization to all women of child-bearing age Concurrent enrollment in another clinical trial Patient inaccessible for follow-up visits required by protocol

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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No

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 |
| --- | --- |
| Active Comparator: Hybrid revascularization<br> | Procedure: Hybrid revascularization<br>* First stage: implantation of the internal mammary artery into LAD in MIDCAB/TECAB procedure Second stage: PCI with drug eluting stents in other coronary arteries qualified for revascularization within 36 hours after surgery<br>|
| Active Comparator: Coronary Artery Bypass Grafting<br> | Procedure: Coronary Artery Bypass Grafting<br>* Coronary artery bypass grafting with sternotomy on or off the pump at discretion of the operator.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Possibility defined by means of (1) a % of pts with complete hybrid procedure according to study protocol, and (2) a % of conversion to standard CABG. Safety defined as a occurrence of MACE such as death, MI, stroke, TVR, or major bleeding. |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postprocedure and follow up angiographic measurements as patency of grafts and restenosis in revascularized segments |  | 1 year | 
| Assessment of quality of life of alive study participants according to SF-36 Health Survey version 2 |  | 1 year | 
| Cost-effectiveness defined as a cost of revascularization procedure and costs of hospitalizations in both groups. |  | 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, Coronary Artery Bypass Grafting, Percutaneous Coronary Interventions, Drug eluting stents