IVUS Study for SV Graft: Y-composite vs Aortocoronary Conduit

Study Overview
=================
Brief Summary
-----------------
Left internal thoracic artery (LITA) has been acknowledged as the first graft of choice for coronary artery bypass grafting (CABG). However, it is still not conclusive which one is the best second graft of choice among right internal thoracic artery, radial artery, right gastroepiploic artery, saphenous vein, and etc., as well as its configuration for CABG. In our institution, saphenous vein has been primarily used for the second graft and we have harvested it with 'No touch technique'. We have been demonstrated the excellent long-term patency of this 'No touch saphenous vein' in many studies. However, it is still unknown which configuration is the better strategy for the saphenous vein as a Y-composite graft based on the left internal thoracic artery versus an aortocoronary conduit. Thus, we aimed to evaluate morphologic change of saphenous vein graft by 1-year intravascular ultrasound (IVUS) study and angiographic patency results between Y-composite graft and aortocoronary conduit.

Detailed Description
-----------------
The enrolled patient underwent routine sternotomy, and left internal thoracic artery (LITA) and saphenous vein (SV) are harvested. After harvest, the patient is randomized to Y-composite group or aortocoronary group. For Y-composite group, SV is anastomosed to LITA as Y-composite fashion. Then, LITA is anastomosed to left anterior descending artery. SV is anastomosed to the rest of the target vessels with sequential anastomosis technique (e.g. diagonal branch, obtuse marginal branch, posterolateral branch and posteriori descending artery). For aortocoronary group, LITA is anastomosed to left anterior descending artery. Then, SV is anastomosed to ascending aorta using proximal anastomosis assist device without clamping the aorta. SV is anastomosed to the rest of the target vessels with sequential anastomosis technique (e.g. diagonal branch, obtuse marginal branch, posterolateral branch and posteriori descending artery). After completion of anastomoses, residual portion of distal SV is collected for microscopic evaluation and measurement of intima-media thickness. At the 1-year follow-up, IVUS study, in addition to coronary angiography, is performed to evaluate the morphologic changes and measure intima-media thickness of the saphenous vein graft.

Official Title
-----------------
Morphologic Changes of the Saphenous Vein as Y-composite Graft Based on the Left Internal Thoracic Artery Versus Aortocoronary Conduit for Coronary Artery Bypass Grafting: A Prospective Randomized Controlled Trial

Conditions
-----------------
Coronary Artery Disease, Morphologic Change

Intervention / Treatment
-----------------
* Procedure: graft configuration in coronary artery bypass grafting


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A patient who is going to receive coronary artery bypass grafting Older than 19 years Coronary artery bypass grafting is going to be performed with left internal thoracic artery and saphenous vein graft Exclusion Criteria: Other concomitant procedures (e.g. valve or aorta surgery) is planned Patients with severe comorbidities which limit the life expectancy of them below 1 year (e.g. terminal cancer) Patients whose left internal thoracic artery or saphenous vein is not available due to the low quality, severe injury, or absence of the graft

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: saphenous vein as Y-composite graft based on the left internal thoracic artery versus aortocoronary conduit
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Y-composite graft<br>The saphenous vein is anastomosed to the middle portion of the left internal thoracic artery as Y-composite fashion. Then, left anterior descending artery, if targeted, is bypassed with left internal thoracic artery. Other native coronary arterial targets are bypassed with saphenous vein graft. | Procedure: graft configuration in coronary artery bypass grafting<br>* Saphenous vein could be used as Y-composite graft or aortocoronary conduit during coronary artery bypass grafting<br>|
| Active Comparator: aortocoronary conduit<br>The saphenous vein is anastomosed to the ascending aorta as aortocoronary fashion. Then, left anterior descending artery, if targeted, is bypassed with left internal thoracic artery. Other native coronary arterial targets are bypassed with saphenous vein graft. | Procedure: graft configuration in coronary artery bypass grafting<br>* Saphenous vein could be used as Y-composite graft or aortocoronary conduit during coronary artery bypass grafting<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intima-media thickness (IMT) | Intima-media thickness measured by intravascular ultrasound (IVUS) | at postoperative 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lumen diameter (LD) | Lumen diameter measured by intravascular ultrasound (IVUS) | at postoperative 1 year | 
| Graft patency | Graft patency measured by coronary angiography | at postoperative 1 year | 
| All cause mortality | all deaths from any cause | at postoperative 1 year | 
| Cardiac death | Any death related to cardiac events, including sudden death during follow-up | at postoperative 1 year | 
| Target vessel revascularization | The number of patients who received any intervention performed for the previously bypassed target vessel during follow-up | at postoperative 1 year | 
| Reintervention | The number of patients who received any coronary intervention performed during follow-up due to the coronary artery disease | at postoperative 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Coronary artery bypass grafting, Saphenous vein, Intravascular ultrasound