Nitinol Stent Implantation in Long Superficial Femoral Artery Lesions: 12-Month Results of the DURABILITY I Study

• Published in: Journal of endovascular therapy 2009-06, Vol.16 (3), p.261-269
• Main Authors: Bosiers, Marc, Torsello, Giovanni, Gißler, Hans-Martin, Ruef, Johannes, Müller-Hülsbeck, Stefan, Jahnke, Thomas, Peeters, Patrick, Daenens, Kim, Lammer, Johannes, Schroë, Herman, Mathias, Klaus, Koppensteiner, Renate, Vermassen, Frank, Scheinert, Dierk
• Format: Article
• Language: English
• Subjects: Adult; Aged; Aged, 80 and over; Alloys; Angioplasty, Balloon; Atherosclerosis - therapy; Design; Equipment Design; Female; Femoral Artery; Follow-Up Studies; Fractures; Graft Occlusion, Vascular - epidemiology; Graft Occlusion, Vascular - prevention & control; Humans; ISO standards; Male; Medical imaging; Middle Aged; Patients; Peripheral Vascular Diseases - therapy; Physical examinations; Stents; Studies; Time Factors; Treatment Outcome
• ISSN: 1526-6028; 1545-1550
• DOI: 10.1583/08-2676.1

Purpose: To evaluate the long-term efficacy and integrity of the PROTÉGÉ 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 PROTÉGÉ EverFlex stent offers a safe and acceptably efficacious means of treating SFA lesions in symptomatic subjects with PAD.