Clinical trial NCT01559350: Graft Patency Analysis of the Right Coronary Artery System
Official title: Graft Patency of the Right Coronary Artery System in OPCAB: Saphenous Vein Graft Versus Right Gastroepiploic Artery
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Coronary Artery Disease
Keywords: OPCAB
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2012-03-21
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who undergo OPCAB for triple vessel disease at Samsung Medical Center are enrolled.

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.

Eligibility criteria: 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

Primary outcomes:
measure: All cause mortality
timeFrame: one year
Secondary outcomes:
measure: Graft occlusion
timeFrame: one year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Young Tak Lee, MD, PhD
role: STUDY_DIRECTOR
References: