Graft Patency Analysis of the Right Coronary Artery System

Terminated

• Conditions: Coronary Artery Disease
• Interventions: Procedure: A right gastroepiploic artery in situ grafting; Procedure: A saphenous vein grafting

• Registration Number: NCT01559350
• Lead Sponsor: Samsung Medical Center

Brief Summary

The ideal grafts for the right coronary artery system in coronary artery bypass surgery remain controversial. The objective of this study is to compare the long-term patency of a right gastroepiploic artery and a saphenous vein graft used for revascularization of the right coronary artery system in off pump coronary artery bypass surgery and to analyze the long-term clinical outcomes.

Total 224 patients will be enrolled according to the randomization protocol.

Check list

1. Laboratories

2. Quantitative coronary analysis (preoperative)

3. Major adverse cardiac and cerebrovascular event

4. coronary CT (coronary angiography if needed) at discharge, 1, 5, 10 years postoperatively

5. Echocardiogram

5. Cardiac enzyme

Detailed Description

The ideal bypass conduit for the right coronary artery remains a subject of intense controversy. A variety of grafts and configurations are used: the right gastroepiploic artery,the right internal thoracic artery in situ or in a Y-graft configuration,the free radial artery implanted into the aorta or the left internal thoracic artery, and the saphenous vein graft. The influence of the type of graft to the right coronary artery system on clinical results remains poorly documented, and the complementary conduit of choice to this system has yet to be determined. No superior long-term patency rate for any of these grafts to the RCA has been clearly established. We have used a saphenous vein and a right gastroepiploic artery for the right coronary artery system.

Study Timeline

• Study Start: 2012-01
• Status Verified: 2012-03
• Study First Submitted: 2012-03-19
• Study First Submitted QC: 2012-03-20
• Study First Posted: 2012-03-21
• Primary Completion: 2015-12
• Study Completion: 2018-12
• Last Update Submitted: 2019-04-03
• Last Update Posted: 2019-04-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Angiographic evidence of severe coronary stenosis on the right coronary territory
• Elective surgery
• Isolated off pump CABG
• Age < 75 years and life expectancy > 5 years
• Preoperative RGEA diameter > 1.5mm
• Normal left ventricular function

Exclusion Criteria

• History of upper abdomen surgery
• History of upper GI bleeding
• Active gastric or duodenal ulcer
• Body mass index > 35kg/m2
• Redo surgery
• Presence of varicose vein
• Contraindication for CABG such as malignancy or liver cirrhosis
• Other configuration than RGEA to RCA territory or SVG to RCA territory

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
RGEA group	A right gastroepiploic artery in situ grafting	A right gastroepiploic artery in situ grafting in the right coronary artery system during OPCAB
SVG group	A saphenous vein grafting	A saphenous vein grafting in the right coronary artery system during OPCAB

Primary Outcome Measures

Name	Time	Method
All cause mortality	one year

Secondary Outcome Measures

Name	Time	Method
Graft occlusion	one year	Coronary CT follow up at discharge, 1, 5 and 10 years postoperatively

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of