Total Arterial Revascularization (TAR)

Study Overview
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Brief Summary
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Total arterial revascularisation with in-situ confihuration of BITA is superior than y-graft in patients underwent CABG.

Detailed Description
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The main hypothesis of the trial is that in-situ configuration of bilateral internal thoracic arteries is superior than Y-graft configuration for MACCE (mortality, myocardial infarction, repeat revascularization, stroke) during mid-term follow-up in patients with CAD who is shedueled for CABG.

Official Title
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Comparison of Total Arterial Revascularization of Y-Graft Versus In-Situ Configuration Using Bilateral Internal Thoracic Arteries

Conditions
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Coronary Artery Disease, Coronary Artery Bypass Grafting

Intervention / Treatment
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* Procedure: Y-Graft
* Procedure: In-Situ


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Coronary Artery Disease Stable angina The need for revascularization of anterior descending and obtuse margin arteries accoring to the 2018 ESC/EACTS Guidelines on myocardial revascularization Informed Consent Form Exclusion Criteria: The diameter of the target arteries is less than 1 mm Stenosis of the subclavian arteries more than 60% STEMI less than 3 month Previous cardiac surgery BMI >35 COPD with FEV1 <60% Concomitant pathology that requires simultaneous surgical treatment Cancer with life expectancy less than 5 years

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 70 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Y-Graft<br>The group includes patients who underwent CABG in Y-Graft Configuration. | Procedure: Y-Graft<br>* Y-Graft Configuration Using BITA. Surgery can be performed off-pump or on the CPB. Both internal thoracic arteries should be harvested in semi-sceletonized fashion. After the administration of 3 mg/kg i/v UFH, the left internal thoracic artery is cut off distally and the right internal thoracic artery is cut off proximally and distally. Then they anastomose the following way. Left internal thoracic artery should be anastomosed to the left anterior descending artery (LAD) at first. Secondly, distal part of the right internal thoracic artery should be anastomosed to the obtuse marginal artery. Finally, proximal part of the right internal thoracic artery is anastomosed to the left internal thoracic artery as Y-graft in the end to side fashion. If it is nessesary, the right coronary artery system can be bypassed by separate autoarterial (eg. radial artery) or autovenous graft with proximal anastomose to the aorta.<br>|
| Active Comparator: In-Situ<br>The group includes patients who underwent CABG in In-Situ Configuration. | Procedure: In-Situ<br>* In-Situ Configuration Using BITA. Surgery can be performed off-pump or on the CPB. Both internal thoracic arteries should be harvested in semi-sceletonized fashion. After the administration of 3 mg/kg i/v UFH, both internal thoracic arteries are cut off distally. Then they anastomose the following way. Right internal thoracic artery should be anastomosed to the left anterior descending artery (LAD) at first. Secondly, left internal thoracic artery should be anastomosed to the obtuse marginal artery. If it is nessesary, the right coronary artery system can be bypassed by separate autoarterial (eg. radial artery) or autovenous graft with proximal anastomose to the aorta.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from MACCE | Composite MACCE (mortality, myocardial infarction, repeated revascularization, stroke) | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Graft patency | Graft patency in 5 years | 5 years | 
| Quality of life (SF-36) | Assessment of the patient's quality of life by the Short Form-36 in 5 years | 5 years | 
| Treadmill stress test | Non-invasive diagnosis of myocardial ischemia | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total Arterial Revascularization, Y-Graft, In-Situ, Coronary Artery Bypass Grafting