Author(s): Bosiers M, Torsello G, Gissler HM, Ruef J, MllerHlsbeck S,
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Abstract PURPOSE: To evaluate the long-term efficacy and integrity of the PROTEGE EverFlex stent in superficial femoral artery (SFA) lesions in symptomatic patients with peripheral artery disease (PAD). METHODS: A prospective, multicenter, nonrandomized study enrolled 151 subjects (111 men; mean age 67.8 years, range 42-93) undergoing percutaneous treatment of de novo, restenotic, or reoccluded SFA lesions between August 11, 2006, and June 26, 2007. Subjects were scheduled to receive a single stent and be evaluated through 12 months following the implant procedure. Occlusions were present in 40\% of the patients. Mean lesion length was 96.4 mm (range 10-150). RESULTS: A total of 161 stents (158 EverFlex) were implanted in the 151 patients: single stents in 93.4\% (141/151) and a second stent in 6.6\% (10/151). One-year follow-up information was available for 88.7\% (134/151) of the study participants; of the remaining 17 subjects, 6 subjects withdrew from the study, 2 were lost to follow-up, and 9 died. Freedom from restenosis data were available for 99.3\% (133/134) of the subjects who completed a 12-month follow-up visit. The mean Rutherford classification fell from 2.8+/-0.8 (range 1-5) at baseline to 0.6+/-1.1 (range 0-5) at 12 months. The mean ankle-brachial index rose from 0.6+/-0.2 (range 0-1.4) at baseline to 0.9+/-0.2 (range 0-1.2) at 12 months. The rates for freedom from >50\% restenosis at 6 and 12 months were 91.3\% (95\% CI 84.9\% to 95.2\%) and 72.2\% (95\% CI 63.8\% to 79.6\%), respectively. The freedom from target lesion revascularization rate at 12 months was 79.1\% (95\% CI 71.2\% to 85.6\%). The 1-year stent fracture rate was 8.1\% (95\% CI 4.0\% to 14.4\%). CONCLUSION: The high freedom from >50\% restenosis and low fracture rate at 12 months suggests that the PROTEGE EverFlex stent offers a safe and acceptably efficacious means of treating SFA lesions in symptomatic subjects with PAD.
This article was published in J Endovasc Ther
and referenced in Journal of Health Education Research & Development