Stents Better Than Angioplasty When Treating Reclosure Of Vein Grafts After Coronary-Artery Bypass Surgery

September 11, 1997

Post-Bypass Patients Treated With Stents Experience Lower Risk Of Complications.

Researchers from Thomas Jefferson University have found that treating the common reclosure of vein grafts in post-bypass patients with stents instead of angioplasty lowers the risk of death, heart attack, and the need for repeat bypass surgery or angioplasty. These findings may point to a new standard of care for the hundreds of thousands of patients who undergo coronary-artery bypass surgery each year - 501,000 such procedures were performed in the United States in 1994 alone - and later experience complications associated with the reclosure of the vein grafts used to construct the bypass. The study appears in the September 11 issue of The New England Journal of Medicine.

Coronary-artery bypass surgery uses veins from the leg to channel blood from the aorta to branches of the coronary arteries, increasing blood flow beyond the obstruction. "The physical nature of a vein graft makes it prone to reclosure. Within 10 years of surgery, nearly half of all bypass grafts are obstructed setting the stage for recurrent angina or heart attack," explained principal investigator Michael P. Savage, M.D., associate professor of medicine, division of cardiology, Jefferson Medical College, Philadelphia, and director, cardiac catheterization laboratory at Thomas Jefferson University Hospital.

Traditionally, balloon angioplasty had been used as an alternative to repeat surgery to reopen the vein grafts that clog with plaque. The long-term outcome of this procedure is poor, resulting in high rates of restenosis, heart attack and death. Fifty percent of patients treated with balloon angioplasty reclose within six months. "The poor long-term outcomes of angioplasty in these patients led us to investigate the use of coronary stents to reopen clogged vein grafts in our multicenter study," said Dr. Savage.

The trial consisted of 220 patients with obstructed bypass vein grafts randomized into two groups - one group received angioplasty to remove the obstruction, the other received Palmaz-Schatz stents (Johnson & Johnson). Six months after their procedure, patients underwent a follow-up angiogram. "Our follow-up demonstrated that the patients who received stents had better long-term clinical results," said Dr. Savage. "Stents had a greater procedural success rate in opening blockages without complications than in the angioplasty group. Also, the diameter of the stented vessels six months post-procedure remained wider than those treated with angioplasty. Finally, but most importantly, the stented group experienced a 36 percent reduction in complications, including death, heart attack and repeat bypass surgery and angioplasty."

Dr. Savage believes that the results of the study, which led to the December 1996 FDA approval of Palmaz-Schatz stents for the treatment of coronary artery bypass graft disease, points toward a new standard of care. "It is exciting to know that stents can now offer better outcomes for patients whose long-term outlook was previously poor."

David L. Fischman, M.D., associate professor of medicine, division of cardiology, Jefferson Medical College, and associate director, cardiac catheterization laboratory at

Thomas Jefferson University Hospital, served as a co-investigator on the study and directed the core laboratory responsible for the angiographic analysis. In addition to the principal investigators from Jefferson, other centers collaborating on the study include the Arizona Heart Institute, Phoenix; Emory University Hospital, Atlanta; Johns Hopkins Hospital, Baltimore; Methodist Hospital, Lubbock, Texas; the Heart Group, Bellevue, Washington; University of California, San Diego; University of Florida, Gainesville; University of Texas, Houston; University of Texas, San Antonio; William Beaumont Hospital, Royal Oak, Mich., Yale University, New Haven, Conn.; and Beth Israel Hospital, Boston.

Thomas Jefferson University

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