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Drug-Eluting Stents Tried for Tibial Occlusive Disease
BY SHERRY BOSCHERT
SEATTLE -- Sirolimus-eluting stents can help patients with tibial occlusive disease and critical limb ischemia but are less successful in patients with very advanced disease, said Dr. Robert A. Lookstein.
He and associates placed 34 sirolimus-eluting stents in 25 patients who had suboptimal results from balloon angioplasty of tibial vessels. Dissatisfaction with an approximately 50% restenosis rate at 6 months after implantation of bare metal stents led Dr. Lookstein and his associates to try the drug-eluting stents, which have been shown to improve patency and outcomes in coronary interventions, compared with bare-metal stents.
All patients in the current series were either poor surgical candidates or lacked sufficient conduit to treat their lesions with surgical bypass, which is widely considered the treatment of choice for these problems, he said at the annual meeting of the Society for Interventional Radiology.
All stent implantations were successful. The mean duration of follow-up in this early experience was 8 months, said Dr. Lookstein of Mount Sinai School of Medicine, New York.
The average lesion length was 26 mm--"relatively short," he noted. "We were not very aggressive with these patients," who were very, very sick. The investigators did treat nine total occlusions, and eight patients required simultaneous femoral-popliteal interventions.
Primary patency (defined as less than 10% stenosis) was seen in 97% of interventions at 1 month after stent implantation, in 90% at 6 months, and in close to 70% at 12 months, he said.
There were two major and two minor amputations within 6 months, all in patients with very advanced clinical symptoms (Rutherford grade V or VI). "I don't think this technology is that effective for those patients, unfortunately," he said.
Three patients died, all from cardiac events. One stent applied to a distal anterior tibial lesion fractured and snapped in half. "The fracture in this series was very concerning. I'm more reluctant to use this technology as you go lower down in the calf," he added.
One patient who did not adhere to postprocedure antiplatelet therapy developed thrombosis of the stent and underwent a successful reintervention. Screen patients for their ability to follow rigid, aggressive antiplatelet therapy after getting the stent, Dr. Lookstein suggested. If they can't afford clopidogrel or won't take the medicine, "I will not use these devices on them," he said.
Dr. Lookstein has no association with the company that makes sirolimus-eluting stents.
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© 2010 VascularWeb. All rights reserved. Use of the VascularWeb site constitutes acceptance of all of the policies, rules and regulations for the site.