title: PEACE I all-comers registry: patency evaluation after implantation of the 4-French Pulsar-18 self-expanding nitinol stent in femoropopliteal lesions.
abstract: OBJECTIVE
  To evaluate the 1-year patency of the 4-F Pulsar-18 self-expanding nitinol stent for treatment of femoropopliteal occlusive disease in a national, prospective, multicenter, all-comers registry.
  
  
  METHODS
  Between January and June 2012, the German PEACE I all-comers prospective registry enrolled 148 patients with symptomatic femoropopliteal lesions (Rutherford category 2-5) undergoing recanalization and implantation of the Pulsar-18 SE nitinol stent at 6 clinical centers. Thirty patients did not have the 12-month follow-up visit (18 declined reevaluation, 5 withdrew consent, and 7 died), leaving 118 patients (64 men; mean 71.9±9.6 age years) for the 1-year evaluation. The average lesion length was 111.5±71.4 mm, and 38 of the 118 lesions were classified as TASC II D. More than half the lesions (67, 56.7%) were chronic total occlusions (CTO). The popliteal segment was involved in 22 (18.7%) lesions. The mean stented length was 122.7±64.5 mm. Routine follow-up included duplex ultrasound at 6 and 12 months. Outcome measures were primary patency and no clinically driven target lesion revascularization (TLR) within 12 months.
  
  
  RESULTS
  The overall primary patency rates after 6 and 12 months were 87.4% and 79.5%, respectively; in the popliteal segments, the rate was 71.4% after 12 months. The overall freedom from TLR was 93.2% after 6 months and 81% after 12 months. Ankle-brachial index, pain-free walking distance, and Rutherford category all improved significantly (p<0.0001) after 6 and 12 months. The primary patency rates in patients with diabetes (p=1.0) and those with renal insufficiency (p=0.8) were not significantly lower compared to the overall rate. There was no significant difference (p=0.67) in restenosis rate for recanalization of CTOs compared to non-CTO lesions.
  
  
  CONCLUSIONS
  In this all-comers registry, the use of the Pulsar-18 self-expanding nitinol stent in femoropopliteal lesions averaging 111.5 mm long showed promising primary patency and freedom from TLR after 6 and 12 months. Diabetes had no negative impact on patency. Primary patency in the popliteal segments was acceptable at 12 months.
authors.affiliation: 1 Klinikum Arnsberg, Vascular Centre, Arnsberg, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Lichtenberg
authors.forename: Oliver
authors.initials: O
authors.lastname: Kolks
authors.forename: Birgit
authors.initials: B
authors.lastname: Hailer
authors.forename: Wilhelm-Friedrich
authors.initials: WF
authors.lastname: Stahlhoff
authors.forename: Christiane
authors.initials: C
authors.lastname: Tiefenbacher
authors.forename: Claus
authors.initials: C
authors.lastname: Nolte-Ernsting
authors.forename: Jawed
authors.initials: J
authors.lastname: Arjumand
authors.forename: Guenther
authors.initials: G
authors.lastname: Wittenberg
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000497:Alloys; D017130:Angioplasty / Q000009:adverse effects / Q000295:instrumentation*; D003251:Constriction, Pathologic; D018572:Disease-Free Survival; 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 / Q000503:physiopathology / Q000628:therapy*; D011150:Popliteal Artery / Q000000981:diagnostic imaging / Q000503:physiopathology*; D011446:Prospective Studies; D011474:Prosthesis Design; 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
keywords: 4-French device; patency; peripheral artery disease; popliteal artery; restenosis; self-expanding stent; superficial femoral artery; target lesion revascularization