Nitinol Stent Implantation in Long Superficial Femoral Artery Lesions: 12-Month Results of the DURABILITY I Study
| Autor: | Marc Bosiers, Thomas Jahnke, Johannes Ruef, Stefan Müller-Hülsbeck, Renate Koppensteiner, Herman Schroë, Giovanni Torsello, Dierk Scheinert, Hans-Martin Gissler, Patrick Peeters, Johannes Lammer, Klaus Mathias, Frank Vermassen, Kim Daenens |
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| Rok vydání: | 2009 |
| Předmět: |
Adult
Male Nitinol stent medicine.medical_specialty Time Factors medicine.medical_treatment Femoral artery Balloon Restenosis medicine.artery Angioplasty Alloys medicine Humans Radiology Nuclear Medicine and imaging Aged Aged 80 and over Peripheral Vascular Diseases Superficial femoral artery business.industry Graft Occlusion Vascular food and beverages Stent Equipment Design Middle Aged Atherosclerosis medicine.disease Surgery Femoral Artery Stenosis Treatment Outcome Female Stents Radiology Cardiology and Cardiovascular Medicine business Angioplasty Balloon Follow-Up Studies |
| Zdroj: | Journal of Endovascular Therapy. 16:261-269 |
| ISSN: | 1545-1550 1526-6028 |
| DOI: | 10.1583/08-2676.1 |
| Popis: | 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).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).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 from50% 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%).The high freedom from50% 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. |
| Databáze: | OpenAIRE |
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