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Research

Photo for SUPERIOR SVG

SUPERIOR SVG

Official Title

Surgical and Pharmacological Novel Interventions to Improve Overall Results of Saphenous Vein Graft Patency in Coronary Artery Bypass Grafting Surgery: An International Multi-Center Randomized Controlled Clinical Trial

Status

Ongoing

Overview

Surgery for blocked arteries in the heart (coronary artery bypass grafting) can be accomplished using veins from the leg sewn onto the heart to provide an alternate path for blood flow, i.e. ‘bypassing’ the blockages. These veins themselves can block over time. This may result in part simply from the trauma from the surgery, in other words, by removing the vein from the leg and then sewing it to the heart. Another mechanism may be the abnormal metabolic processes within the body responsible for the plaque build-up of the heart arteries in the first place – this may lead to the blockages of the veins used for bypass. In the present era of heart bypass surgery, this incidence of veins blocking remains high despite advances in blood thinners and cholesterol medications. This study is designed to determine whether two new interventions may potentially reduce the incidence of blockages in the veins used for heart bypass surgery. One is a surgical technique significantly reducing the trauma associated with removing the leg vein prior to use as a bypass graft onto the heart. The second intervention is the use of a nutritional supplement before and after surgery which is composed of fish oils. The study will recruit sufficient patients to provide strong and relevant conclusions regarding both study questions. It will be highly applicable also because it will include approximately 1,550 patients from approximately 50 hospitals across many countries. We believe these techniques will result in significantly less vein blockages in patients one year after heart bypass surgery.

Study Design

Randomized, controlled, 2×2 factorial design;

Primary Endpoint

Primary Outcome

Surgical Arm: Proportion of study SVGs (“no touch” versus conventionally harvested) which are totally (100%) occluded on cardiac CT angiography at 1-year post-CABG and death due to cardiovascular or unknown causes.

Pharmacological Arm: Proportion of patients with greater than or equal to 1 graft (saphenous or arterial) totally (100%) occluded on cardiac CT angiography at 1-year post-CABG and death due to cardiovascular or unknown causes, comparing the fish-oil to placebo groups.

Number of Patients

250

Number of Sites

15

Number of Countries

3

Study Period

2011–2014

Principal Investigator

Stephen Fremes, Richard Novick

Program Manager

Susan Chrolavicius, Shirley Pettit

Research Coordinator

Kate Brady