Late-Breaking Clinical Trials at the American Heart Association’s Scientific Sessions 2001

Abstract

The PRoject of Ex-vivo Vein graft ENgineering via Transfection (PREVENT) II trial found that a double-stranded piece of DNA called the E2F duplex decoy significantly reduced failure of vein grafts after coronary artery bypass surgery (CABG), according to Eberhard Grube, MD, of the Heart Center in Sieburg, Germany, during the American Heart Association’s 2001 Scientific Sessions in Anaheim, Calif. During the Late-Breaking Clinical Trials Plenary Session on November 12, 2001, Dr Grube said that his decoy blocks vascular smooth muscle proliferation, which is the core problem in vein graft failure. Eberhard Grube, MD (photo by Paul C. SoRelle) The graft is treated during CABG after the vein has been removed from the leg. A solution containing the E2F decoy is placed in a tube with a stopcock on one side and a syringe at the other, which is used to apply pressure. The vein is placed in the tube and pressure is applied via the syringe to ≈6 lbs/in2 for 10 minutes, Dr Grube said. That is enough to insure that 80% of the cells in the graft will take up the decoy. The transfected graft then is used to bypass blocked coronary arteries. In the study, 101 patients who had undergone CABG were randomly assigned to the treatment group, and 99 were assigned to placebo. In angiographic studies performed on 61 placebo patients and 75 treated patients who received a total of 309 grafts, the E2F decoy was associated with a 30% relative reduction in a composite index of vein graft failure and death, said Dr Grube. In addition, there was a 30% reduction in the size of vessel wall volume. According to Dr Grube, the results are similar to those in the PREVENT I trial, which used E2F to treat bypass veins in peripheral artery disease. He …