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Sustained effectiveness of paclitaxel-eluting stent observed in patients with diabetes
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For treating superficial femoral artery lesions in diabetic patients, the paclitaxel-eluting stent was shown to have sustained effectiveness at 1 and 2 years compared with percutaneous transluminal angioplasty, according to results of a late-breaking clinical trial presented at the 65th Vascular Annual Meeting of the Society for Vascular Surgery.
“Most superficial femoral artery interventions have worse outcomes in diabetics,” Sean P. Lyden, MD, with the Cleveland Clinic Foundation and researcher of the prospective, randomized trial, told Cardiology Today. “Diabetics do as well as nondiabetics with the paclitaxel-eluting [Zilver PTX, Cook Medical] stent.”
The trial involved 479 patients with symptomatic de novo or restenotic superficial femoral artery lesions who were treated at 55 institutions in the United States, Japan and Germany. All of patients were randomly assigned to receive a paclitaxel-eluting stent (n=241) or percutaneous transluminal angioplasty (PTA; n=238). In the event of acute PTA failure, defined as at least 30% residual stenosis, patients underwent secondary randomization to either provisional bare metal stent (Zilver) or provisional paclitaxel-eluting stent (Zilver PTX).
Overall, 118 patients had acutely successful PTA, and 120 did not. Of those 120 patients, 61 had provisional paclitaxel-eluting stent implantation vs. 59 who had provisional bare metal stent implantation. Among the 302 patients who received primary or provisional paclitaxel-eluting stent treatment, 48.3% had diabetes.
For patients with and without diabetes, demographics and lesion characteristics were similar. Event-free survival was comparable between groups, but slightly favored the nondiabetes group at both 1 year (93.5% vs. 89.2%) and 2 years (88.7% vs. 84.4%). Also similar were paclitaxel-eluting stent patency rates, which were nonsignificantly higher in nondiabetes patients at 1 year (85.2% vs. 83.9%) and 2 years (77.5% vs. 74.1%).
For more information:
- Lyden S. LB4. Presented at: 2011 Vascular Annual Meeting; June 16-18, 2011; Chicago.
Disclosure: Dr. Lyden has received honoraria from Cook Medical and Medtronic, consulting fees and other payment from Boston Scientific, and is on the scientific advisory committee for Medtronic.
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