Beaumont Launches 5-Year 2600 Patient Study to Compare Surgery to Stenting

Beaumont Health System has launched an important research study comparing the safety and effectiveness of open-heart surgery versus angioplasty with stenting for patients with left main coronary artery disease. A total of 2,600 patients at 165 centers around the world will participate in the study sponsored by Abbott Cardiovascular Systems.

Left main artery disease is a life threatening form of heart disease involving blockage of the left main coronary artery which branches off from the aorta to provide blood flow to the left ventricle of the heart. When this artery becomes narrowed, blood flow to the heart is decreased causing chest pain, heart failure or sudden death.

Coronary artery bypass graft surgery has been the traditional form of treatment for left main disease. Until recently, only patients at high risk for surgery were considered eligible for less invasive treatment with angioplasty and stenting.

“The results of this study are critically important,” says Simon Dixon, M.D., co-principal investigator, and Beaumont Health System chair, Cardiovascular Medicine. “If the results prove that angioplasty with stenting is as safe and effective as open-heart surgery, it will change medical practice and allow us to treat these patients less invasively.”

“These research results will help us provide multiple treatment options for patients with life threatening coronary anatomy,” says Marc Sakwa, M.D, Heart and Vascular Center of Excellence chair, Beaumont Health System, and co-principal investigator. “It will provide important, evidence-based information concerning the best approach to achieve the best outcomes in treating coronary artery disease.”

During angioplasty, a catheter with a deflated balloon mounted on its tip is passed through a catheter into the narrowed area of the left main heart artery. The doctor inflates the balloon to open the narrowed artery. A hollow, flexible metal mesh tube called a stent is then guided into the heart through the catheter and placed inside the left main coronary artery to keep it open. This can improve blood flow to the heart without bypass surgery.

With coronary artery bypass graft surgery, also called open-heart surgery, a patient receives anesthesia and a surgeon makes a cut down the middle of the breastbone to open the rib cage to reach the heart. The patient is usually placed on a heart-lung machine and the heart is temporarily stopped while the surgeon attaches grafts to bypass the blockage in the left main coronary artery. Sometimes the surgery can be done through smaller, “keyhole” incisions using special instruments. This is called minimally invasive heart surgery.

Patients enrolled in the study will be randomly assigned to receive open-heart surgery or angioplasty with placement of one of two drug-coated stents (the XIENCE PRIME or the XIENCE V ). Recent studies have shown that drug-coated stents may be better at decreasing heart artery re-narrowing compared to uncoated stents. It is believed that the drug coating on the stent reduces regrowth of tissue into the stented area.

Candidates for research participation are those with “unprotected” left main coronary artery disease (those who are not “protected” by a previous bypass graft to at least one of the two major coronary arteries branching off the left main artery).

Participants are expected to remain in the study for five years with follow-up visits and phone calls.

The study will compare death rates from any cause, rates of heart attack and stroke, health-related quality of life and treatment costs among participants randomized to the two treatments.

For enrollment information, contact Beaumont’s Cardiovascular Medicine Research department at 248-898-9161.

About Beaumont Heart Care
Beaumont is Michigan’s, and one of the nation’s, most experienced providers of heart care, ranking on U.S. News & World Report’s 2012-13 “America’s Best Hospitals” list for cardiology and heart surgery. The Beaumont Heart and Vascular Center is a comprehensive, state-of-the-art facility that’s dedicated to the prevention, diagnosis and treatment of heart problems. Beaumont’s Ernst Cardiovascular Center includes six specialty clinics offering advanced and minimally invasive treatments for heart valve disease, atrial fibrillation, congestive heart failure, aortic aneurysm and dissection, plus preventive screening for adults and high school students. Beaumont’s Ministrelli Women’s Heart Center is the first in Michigan devoted exclusively to the prevention, diagnosis, and research of heart disease in women. Find out more at http://heart.beaumont.edu/.

HIC #2011-242