A Prospective Randomized Study for Comparison of Y-Composite Grafts

Study Overview
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Brief Summary
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The purpose of this study is to compare early and 1-year graft patency rates of saphenous vein composite grafts with those of right internal thoracic artery composite graft and mid-term clinical outcomes in patients who undergo off-pump coronary artery bypass grafting(OPCAB). We also evaluate microscopic findings of saphenous vein graft harvested no touch technique and used as composite graft.

Detailed Description
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The SAVERITA trial was designed as a randomized, controlled trial to recruit 224 patients who undergo off-pump coronary artery bypass using Y-composite graft based on the left internal thoracic artery. Patients were randomized by use of a randomization table. Composite conduit was made using saphenous vein or right internal thoracic artery according to the randomization result. The primary end point is to evaluate early and 1-year postoperative graft patency. The secondary end points are overall survival, freedom from cardiac death and freedom from MACCE(major adverse cardiac or cerebrovascular events). In saphenous vein group, 20 remnant saphenous vein specimen was evaluated histologically to compare the difference between composite grafted vein and manually dilated saphenous vein.

Official Title
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A Randomized Comparison of the SAphenous VEin Versus Right Internal Thoracic Artery as a Y-Composite Graft (SAVE-RITA Trial)

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Procedure: saphenous vein composite grafting
* Procedure: right internal thoracic artery composite grafting


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age equal or more than 40 age equal or less than 75 patients who agree to the enrollment Exclusion Criteria: Patients with heart failure (left ventricular ejection fraction < 25%) patients who have intractable ventricular arrhythmia patients who has been treated for cancer patients who has infectious disease patients who are planned to undergo combined cardiac surgery patients who has medical co-morbidity with expected survival less than 1 year patients who has a problem using right internal thoracic artery or saphenous vein patients with a history of previous cardiac surgery Patients with chronic renal failure patients who undergo emergency operation

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 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: SVG group<br>patients who underwent off-pump coronary artery bypass using saphenous vein composite grafting based on the left internal thoracic artery use saphenous vein as a composite graft connected to the left internal thoracic artery | Procedure: saphenous vein composite grafting<br>* use saphenous vein as a composite graft connected to the left internal thoracic artery<br>* Other names: SAVERITA SVG;|
| Active Comparator: RITA group<br>patient who underwent off-pump coronary artery bypass using right internal thoracic artery composite grafting based on the left internal thoracic artery use right internal thoracic artery as a composite graft connected to the left internal thoracic artery | Procedure: right internal thoracic artery composite grafting<br>* right internal thoracic artery is used as a composite graft connected to the left internal thoracic artery<br>* Other names: SAVERITA RITA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1 Year Graft Patency Rates | 1 year graft patency of second limb conduits measured by 1 year coronary angiography | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | Overall survival rate at 4 years | 4 years | 
| Freedom From Cardiac Death | Freedom rate from cardiac death at 4 years | 4 years | 
| Freedom From MACCE(Major Adverse Cardiac and Cerebrovascular Events) | freedom from MACCE(major adverse cardiac and cerebrovascular events)at 4 years | 4 years | 
| Early Angiographic Patency Rates | The patency rate of the SV side-arm composite graft evaluated with coronary angiograms early after CABG | 1.4days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coronary artery bypass, off-pump surgery, composite graft, saphenous vein, internal thoracic artery