November 11, 2013 — Researchers at Saint Luke’s Mid America Heart Institute led a study that showed marked, long-term improvement in health status in patients suffering from peripheral artery (PAD) treated with the SMART nitinol self-expandable stent. Cordis Corp., manufacturer of the SMART Stent, sponsored the study.
David Safley, M.D., interventional cardiologist and lead investigator for the study, presented the findings at the annual Vascular Interventional Advances (VIVA) conference in Las Vegas. Study authors also included Elizabeth Magnuson, Sc.D., Haiyan Li, M.S., and David Cohen, M.D., M.Sc. director, cardiovascular research at Saint Luke's Mid America Heart Institute and professor, 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 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 (SMART 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 SMART 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 one, six, 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 SMART 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 Safley.
For more information: www.vivapvd.com, www.cordis.com