title: SUMMIT registry: one-year outcomes after implantation of the EPIC self-expanding nitinol stent in the femoropopliteal segment.
abstract: OBJECTIVE
  To evaluate the efficacy and safety of the EPIC self-expanding nitinol stent in patients with femoropopliteal occlusive disease.
  
  
  METHODS
  The prospective, multicenter, nonrandomized SUMMIT study (ClinicalTrials.gov identifier NCT01336101) enrolled 100 patients (76 men; mean age 67.6 years) with symptomatic de novo femoropopliteal disease undergoing angioplasty and subsequent implantation of EPIC stents from April 2011 to October 2011. The mean lesion length was 69.5±40.5 mm; 29 of the lesions were total occlusions. Clinical examination and duplex sonography were prospectively performed after 6 and 12 months. The primary endpoint was in-stent restenosis as assessed by duplex ultrasound (peak systolic velocity ratio ≥2.5). Further outcome measures were patency rates, improvement in the Rutherford category and ankle-brachial index (ABI), as well as stent integrity based on plain radiography.
  
  
  RESULTS
  A residual stenosis <30% was achieved in all procedures. The primary patency rates were 96.8% after 6 months and 85.1% at 1 year. The secondary patency rates were 97.9% and 91.2% at the same intervals. The 1-year binary >50% restenosis rate was 15.7%. Freedom from target lesion revascularization at 1 year was 92.3%. Between baseline and the 12-month follow-up, the mean ABI increased from 0.73 to 0.96, and the mean Rutherford category decreased from 2.9 to 1.0 (p<0.001 for both comparisons). Plain radiographs from 86 patients at the 12-month examination confirmed the absence of stent fractures.
  
  
  CONCLUSIONS
  The outcome of the SUMMIT registry demonstrates that the EPIC self-expanding nitinol vascular stent is a safe and effective device for treating peripheral artery disease in the femoropopliteal segment.
authors: 1 Center for Vascular Medicine, Park Hospital Leipzig, Germany.
authors: Martin
authors: M
authors: Werner
authors: Michael
authors: M
authors: Piorkowski
authors: Markus
authors: M
authors: Thieme
authors: Thomas
authors: T
authors: Nanning
authors: Ulrich
authors: U
authors: Beschorner
authors: Aljoscha
authors: A
authors: Rastan
authors: Thomas
authors: T
authors: Zeller
authors: Dierk
authors: D
authors: Scheinert
mesh_terms: D000368:Aged; D000497:Alloys; D000800:Angioplasty, Balloon / Q000009:adverse effects / Q000295:instrumentation*; D055109:Ankle Brachial Index; D003251:Constriction, Pathologic; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging / Q000503:physiopathology; D005858:Germany; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D058729:Peripheral Arterial Disease / Q000175:diagnosis / Q000628:therapy*; D011150:Popliteal Artery / Q000000981:diagnostic imaging / Q000503:physiopathology; D011446:Prospective Studies; D011474:Prosthesis Design; D011859:Radiography; D012008:Recurrence; D012042:Registries; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome; D018616:Ultrasonography, Doppler, Duplex; D014654:Vascular Patency
chemical_list: D000497:Alloys; C013616:nitinol