MOBILITY Supports Self-Expanding and Balloon-Expandable Stents for Treating Complex Iliac Disease
May 10, 2012—According to data presented by Michael R. Jaff, DO, at the Society for Cardiovascular Angiography and Interventions (SCAI) 2012 scientific sessions, the MOBILITY study has shown that patients with complex peripheral artery disease lesions who were treated with either a balloon-expandable stent system or a self-expanding stent system experienced improvements in walking ability while maintaining low rates of restenosis and major adverse events.
A summary issued by the SCAI noted that patients with iliac artery disease have traditionally been excluded from clinical trials if they have highly calcific lesions. However, these patients are often more representative of the real-world population treated by interventionists.
The MOBILITY trial was designed to test the effectiveness of a self-expanding stent system and a balloon-expandable stent system in the iliac artery in patients with intermittent claudication or critical limb ischemia. Investigators in the multicenter trial enrolled 304 patients with 384 lesions. Of those, 151 patients were treated with the Absolute Pro peripheral self-expanding stent system (Abbott Vascular, Santa Clara, CA), and 153 patients were treated with the Omnilink Elite vascular balloon-expandable stent system (Abbott Vascular). The investigators did not see a high degree of calcification, which has been thought to result in failure of endovascular therapy.
After 9 months, the rate of major adverse events was 6.1% for patients treated with the Absolute Pro and 5.4% for patients treated with the Omnilink Elite, significantly below the primary endpoint goal of 19.5% (P < .0001). Walking ability significantly improved for both sets of patients, and restenosis rates were 8.4% for Absolute Pro and 9% for Omnilink Elite, even though moderate-to-severe calcification was noted in 90% of all lesions treated.
“These results demonstrate that balloon-expandable and self-expandable stent systems are effective even in real-world patients,” commented Dr. Jaff. “At 9 months, we saw improvements in walking ability while still maintaining low rates of restenosis and major adverse events. The study shows even patients with severe lesions can be successfully treated, helping restore their movement. After 9 months, patients saw improvement in walking distance and speed, as well as the ability to climb stairs.”