Clinical trial NCT05704296: Saphenous Vein as Y-composite Versus Aortocoronary Conduit for CABG
Official title: Comparison Between 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Keywords: coronary artery bypass grafting
saphenous vein
coronary angiography
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2023-01-30
Enrollment: 290
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Saphenous vein as Y-composite graft based on the left internal thoracic artery versus aortocoronary conduit
Primary purpose: TREATMENT

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 posterior 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).

At 1-year follow-up, coronary angiography is performed to evaluate the patency of the saphenous vein graft. Clinical outcomes are also evaluated.

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
* Patients whose ascending aorta is not suitable to aortocoronary anastomosis (e.g. ascending aorta aneurysm, porcelain aorta)
* Emergency operation
* Patients who have connective tissue disease
* Reoperative coronary artery bypass grafting

Primary outcomes:
measure: Graft patency
timeFrame: at postoperative 1 year
Secondary outcomes:
measure: All-cause mortality
timeFrame: at postoperative 1 year
measure: Cardiac death
timeFrame: at postoperative 1 year
measure: Target vessel revascularization
timeFrame: at postoperative 1 year
measure: Reintervention
timeFrame: at postoperative 1 year
measure: Major Adverse Cardiac Events (MACEs)
timeFrame: at postoperative 1 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Ho Young Hwang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: