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SUPERA Interwoven Nitinol Stent Outcomes in Above-Knee IntErventions (SAKE) Study
Institution:1. Laboratory for Thrombosis and Hemostasis, Department of Internal Medicine, Maastricht University Medical Centre, Maastricht, The Netherlands;2. Department of Internal Medicine, Flevohospital, Almere, The Netherlands;1. Department of Radiology, UC Davis Medical Center, 4860 Y Street, Suite 3100, Sacramento, CA 95817;2. Department of Radiology, Duke University Medical Center, Durham, North Carolina;1. Departments of Radiology, University Hospitals of Geneva, Rue Gabrielle-Perret-Gentil 4, Geneva 14 1211, Switzerland;2. Departments of Angiology, University Hospitals of Geneva, Rue Gabrielle-Perret-Gentil 4, Geneva 14 1211, Switzerland;1. Vascular and Interventional Specialists of Orange County, Heart and Vascular Center, St. Joseph Hospital, Orange, CA 92868;2. Metro Heart and Vascular, Wyoming, Michigan;3. Miller Scientific Consulting, Asheville, North Carolina;1. Division of Cardiovascular Diseases, Vascular and Interventional Radiology Translational Laboratory, Department of Radiology, Mayo Clinic, 200 First Street SW, Rochester, MN 55902;2. Department of Internal Medicine, Division of Vascular and Endovascular Surgery, Vascular and Interventional Radiology Translational Laboratory, Department of Radiology, Mayo Clinic, 200 First Street SW, Rochester, MN 55902;3. Division of Vascular Interventional Radiology, Vascular and Interventional Radiology Translational Laboratory, Department of Radiology, Mayo Clinic, 200 First Street SW, Rochester, MN 55902.;1. Department of Vascular and Endovascular Surgery, Wake Forest School of Medicine, Winston-Salem, NC;2. Division of Public Health Sciences, Department of Biostatistical Sciences, Wake Forest School of Medicine, Winston-Salem, NC;3. Division of Public Health Sciences, Department of Social Sciences and Health Policy, Wake Forest School of Medicine, Winston-Salem, NC
Abstract:PurposeTo report experience with the novel interwoven-wire self-expanding nitinol SUPERA stent (IDEV Technologies, Inc/Abbott Laboratories, Inc, Webster, Texas) for the treatment of severely diseased superficial femoral and popliteal arteries.Materials and MethodsConsecutive patients with severely diseased superficial femoral and popliteal arteries who received SUPERA stents (n = 80 patients 98 limbs]; mean age, 70.8 y; 80% male) were retrospectively identified. Patients were followed for an average of 14.3 months after intervention.ResultsTotal occlusions were present in 39% of the lesions, 21% had tissue loss, and 61% demonstrated calcification on fluoroscopy. Patients were prescribed dual antiplatelet therapy (aspirin and clopidogrel) for at least 30 days unless contraindicated, followed by aspirin alone indefinitely. The mean (± SD) lesion length was 143 mm (± 98). Based on need for clinical intervention, primary patency was 96.9% at 6 months and 85.8% at 12 months (Kaplan-Meier estimates). Assisted primary patency and secondary patency rates at 12 months were 96.8% and 100%, respectively. Ankle-brachial index increased from 0.60 at baseline to 0.83 at last follow-up (P < .001). No stent fractures were found by fluoroscopy inspection in 19 limbs (16 patients) that required reintervention.ConclusionsBased on experience with multiple operators at a single clinical center, the interwoven nitinol stent design provides a viable option for high-grade obstructive disease in the femoropopliteal artery.
Keywords:ABI"}  {"#name":"keyword"  "$":{"id":"key0010"}  "$$":[{"#name":"text"  "_":"ankle-brachial index  PAD"}  {"#name":"keyword"  "$":{"id":"key0020"}  "$$":[{"#name":"text"  "_":"peripheral arterial disease  SFA"}  {"#name":"keyword"  "$":{"id":"key0030"}  "$$":[{"#name":"text"  "_":"superficial femoral artery
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