A Prospective Randomized Study for Comparison of Y-Composite Grafts

N/ACompletedNCT01051986

Seoul National University Hospital224 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

224

Conditions

Coronary Artery Disease

Interventions

saphenous vein composite graftingPROCEDURE

use saphenous vein as a composite graft connected to the left internal thoracic artery

right internal thoracic artery composite graftingPROCEDURE

right internal thoracic artery is used as a composite graft connected to the left internal thoracic artery

Eligibility

Sex: ALLMin age: 40 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Seoul National Uinversity Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

1 Year Graft Patency Rates

1 year graft patency of second limb conduits measured by 1 year coronary angiography

Time frame: one year

Secondary Outcomes

Overall Survival

Overall survival rate at 4 years

Time frame: 4 years

Freedom From Cardiac Death

Freedom rate from cardiac death at 4 years

Time frame: 4 years

Freedom From MACCE(Major Adverse Cardiac and Cerebrovascular Events)

freedom from MACCE(major adverse cardiac and cerebrovascular events)at 4 years

Time frame: 4 years

Early Angiographic Patency Rates

The patency rate of the SV side-arm composite graft evaluated with coronary angiograms early after CABG

Time frame: 1.4days

Data from ClinicalTrials.gov

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