Study released at Vascular Interventional Advances scientific conference today
KANSAS CITY, Mo., Oct. 8, 2013 /PRNewswire-USNewswire/ -- Data from a study led by researchers at Saint Luke's Mid America Heart Institute showed marked, long-term improvement in health status in patients suffering from peripheral artery disease treated with the S.M.A.R.T. Nitinol Self-Expandable Stent. The study was sponsored by Cordis Corporation, (Fremont, Calif.), manufacturer of the S.M.A.R.T. Stent.
The findings were presented today at the annual Vascular Interventional Advances (VIVA) conference in Las Vegas by David M. Safley, M.D., interventional cardiologist and lead investigator for the study. Study authors also included Elizabeth Magnuson, Sc.D., Haiyan Li, M.S., and David Cohen, M.D., M.Sc. director of Cardiovascular Research at Saint Luke's Mid America Heart Institute and professor at the University of Missouri-Kansas City School of Medicine.
"One of the main goals of treating lower-extremity peripheral artery disease is symptom relief and improved health status," said Dr. Safley. "Although there have been substantial advances in device-based therapy in recent years, there is little data evaluating the impact of these treatments on patient-reported outcomes. In addition, most previous studies have focused on only short-term changes, so we wanted to see whether and to what extent any early benefits of revascularization were maintained."
The study used data from the STROLL (S.M.A.R.T. Vascular Stent Systems in the Treatment of Obstructive Superficial Femoral Artery Disease) Trial to measure the degree and extent of meaningful improvements in both symptoms and quality of life in patients with Superficial Femoral Artery (SFA) disease in the peripheral arteries treated with the S.M.A.R.T. Stent.
A total of 250 patients were enrolled at 39 U.S. centers with a baseline health status that was substantially impaired. Health status was assessed at 1, 6, 12, 24, and 36 months using generic and peripheral artery-specific questionnaires. At one month follow-up there was significant improvement on virtually all measurement scales. These early benefits were sustained through three-year follow up with only minimal attenuation over time.
"These findings demonstrate that among patients with symptomatic superficial femoral artery disease, opening the artery using the S.M.A.R.T. Nitinol Self-Expandable Stent System provides clinically meaningful improvements in health status and quality of life that are maintained for at least three years," said Dr. Safley.
Peripheral artery disease in the lower extremities is the narrowing or blockage of the vessels that carry blood from the heart to the leg and is primarily caused by the build up of fatty plaque in the arteries. An estimated 8 million people in the U.S. have PAD. The classic symptom is pain in the lower legs with exertion such as walking, but up to 40 percent of individuals with PAD do not experience symptoms. People with PAD are at increased risk of developing coronary artery disease and cerebral vascular disease which could lead to heart attack and stroke. Placement of a stent – a small wire mesh tube – in the artery can help to restore blood flow and relieve discomfort.
For more information about the research findings, visit http://www.vivapvd.com/conference.
About Saint Luke's Mid America Heart Institute
Recognized as one of the leading outcomes research centers in the country, Saint Luke's Mid America Heart Institute has led more than 115 clinical research trials in all aspects of cardiovascular disease. The Institute's clinicians and researchers have pioneered methods for quantifying patients' experience and outcomes of their disease and using these data as endpoints in clinical trials, as markers of health care quality, and as tools in improving patient care.
SOURCE Saint Luke's Mid America Heart Institute