A Prospective Randomized Study for Comparison of Y-Composite Grafts (SAVERITA)

Seoul National University

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Procedure: saphenous vein composite grafting; Procedure: right internal thoracic artery composite grafting

Study type: Interventional

Funder types: Other

Identifiers

NCT01051986

H-0803-024-237

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 224 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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224 participants in 2 patient groups

SVG group

Active Comparator group

Description:

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

Treatment:

Procedure: saphenous vein composite grafting

RITA group

Active Comparator group

Description:

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

Treatment:

Procedure: right internal thoracic artery composite grafting