Cordis SMART Stent Maintains Improved Quality of Life in 3-Year STROLL Data

January 21, 2014—Data from the STROLL (SMART Nitinol Self-Expanding Stent in the Treatment of Obstructive Superficial Femoral Artery Disease) trial were presented at ISET 2014: 26th Annual International Symposium on Endovascular Therapy in Miami Beach, Florida. STROLL is a multicenter, nonrandomized, single-arm prospective trial studying the safety and efficacy of the SMART stent (Cordis Corporation, Bridgewater, NJ).

According to the ISET announcement, the STROLL study was composed of patients treated at one of 39 centers. The data showed that these patients with peripheral artery disease maintained improved quality of life—including being able to walk farther—3 years after being treated with stents to open up their blocked leg arteries. Leg arteries remained open in approximately three-quarters of patients who were treated with nitinol stents, and they continued to enjoy improved quality of life, according to the study.

Michael R. Jaff, DO, who is Professor of Medicine at Harvard Medical School in Boston, Massachusetts, is lead author of the study. In the ISET press release, Dr. Jaff commented, “It’s impressive that the stent continued to perform so well even 3 years after treatment. Patients still felt much better and walked farther and faster than they did before treatment.”

As summarized by the ISET announcement, self-expanding stents were placed in blockages in the superficial femoral artery of 250 patients. Blockages averaged 7.7 cm in length and 23.6% of them were completely closed. At 3 years after treatment, 72.7% of arteries remained opened in 209 patients. There was a 3.6% rate of stent fractures, all of which were the least-severe form and caused no problems and continued to keep the arteries open. Blood pressure in the legs remained significantly improved, with almost no change over 3 years. Additionally, patients maintained their improved health-related quality of life as measured by several factors, including symptoms, walking distance, and speed.