Graft Patency Analysis of the Right Coronary Artery System

Overview

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

Full Title of Study: “Graft Patency of the Right Coronary Artery System in OPCAB: Saphenous Vein Graft Versus Right Gastroepiploic Artery”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 2015

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.

Interventions

  • Procedure: A right gastroepiploic artery in situ grafting
    • A right gastroepiploic artery in situ grafting in the right coronary artery system during OPCAB
  • Procedure: A saphenous vein grafting
    • A saphenous vein grafting in the right coronary artery system during OPCAB

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • All cause mortality
    • Time Frame: one year

Secondary Measures

  • Graft occlusion
    • Time Frame: one year
    • Coronary CT follow up at discharge, 1, 5 and 10 years postoperatively

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Samsung Medical Center
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Young Tak Lee, MD, PhD, Study Director, Samsung Medical Center

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