title: Primary Self-EXPANDing Nitinol Stenting vs Balloon Angioplasty With Optional Bailout Stenting for the Treatment of Infrapopliteal Artery Disease in Patients With Severe Intermittent Claudication or Critical Limb Ischemia (EXPAND Study).
abstract: OBJECTIVE
  To compare primary placement of a self-expanding nitinol stent to percutaneous transluminal angioplasty (PTA) with bailout stenting in infrapopliteal arteries of patients with severe intermittent claudication or critical limb ischemia (CLI).
  
  
  METHODS
  In the EXPAND trial (ClinicalTrials.gov; identifier NCT00906022), 92 patients (mean age 72.9±9.5 years; 62 men) undergoing treatment for infrapopliteal stenosis in 11 European centers were randomized 1:1 to either self-expanding nitinol stenting with the Astron Pulsar/Pulsar-18 nitinol stent or PTA with bailout stenting. The primary endpoint was sustainable clinical improvement after 12 months, defined as a ≥1-category increase for Rutherford category 3 patients or a ≥2-category increase for CLI patients (Rutherford categories 4/5) compared with baseline. Furthermore, target lesion revascularization (TLR), mortality, and amputation were assessed after 12 months.
  
  
  RESULTS
  Sustained clinical improvement at 1 year was observed in 74.3% of the patients treated with primary stenting and in 68.6% of the patients treated with PTA and bailout stenting (p>0.05). Kaplan-Meier estimates of freedom from TLR (76.6% and 77.6%), mortality (7.4% vs 2.1%), and amputation [8.9% (major 6.7%) vs 13.2% (major 8.7%)] at 1 year were not significantly different.
  
  
  CONCLUSIONS
  Primary self-expanding nitinol stenting did not show statistically different clinical outcomes compared to angioplasty with bailout stenting for infrapopliteal lesions.
authors.affiliation: Vascular Center Berlin, SGK Behandlungszentrum, Berlin, Germany k-l.schulte@gefaesszentrum.berlin.
authors.forename: Karl-Ludwig
authors.initials: KL
authors.lastname: Schulte
authors.affiliation: Department of Angiology, Medical University Graz, Austria.
authors.forename: Ernst
authors.initials: E
authors.lastname: Pilger
authors.affiliation: Internal Medicine, Dresden-Friedrichstadt Hospital, Dresden, Germany.
authors.forename: Sebastian
authors.initials: S
authors.lastname: Schellong
authors.affiliation: Department of Medical Imaging, UHN Toronto General Hospital, Toronto, Ontario, Canada.
authors.forename: Kong Ten
authors.initials: KT
authors.lastname: Tan
authors.affiliation: Miami Cardiac and Vascular Institute, Baptist Hospital, Miami, FL, USA.
authors.forename: Frederic
authors.initials: F
authors.lastname: Baumann
authors.affiliation: Department of Angiology, St. Gertrauden Krankenhaus, Berlin, Germany.
authors.forename: Ralf
authors.initials: R
authors.lastname: Langhoff
authors.affiliation: Department of Vascular and Endovascular Surgery, University of Münster, Germany.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Torsello
authors.affiliation: Department of Angiology, Universitäts-Herzzentrum Freiburg-Bad Krozingen, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Zeller
authors.affiliation: Internal Medicine, Diakonissenkrankenhaus Mannheim, Germany.
authors.forename: Klaus
authors.initials: K
authors.lastname: Amendt
authors.forename: Marianne
authors.initials: M
authors.lastname: Brodmann
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000497:Alloys; D000671:Amputation, Surgical; D000800:Angioplasty, Balloon / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D016638:Critical Illness; D018450:Disease Progression; D018572:Disease-Free Survival; D057510:Endovascular Procedures / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D005060:Europe; D005260:Female; D006801:Humans; D007383:Intermittent Claudication / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D007511:Ischemia / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D053208:Kaplan-Meier Estimate; D023821:Limb Salvage; D008297:Male; D008875:Middle Aged; D058729:Peripheral Arterial Disease / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D011150:Popliteal Artery / Q000503:physiopathology; D011446:Prospective Studies; D011474:Prosthesis Design; D012008:Recurrence; D018570:Risk Assessment; D012307:Risk Factors; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome; D014654:Vascular Patency
chemical_list: D000497:Alloys; C013616:nitinol
keywords: amputation; bailout stenting; below-the-knee interventions; critical limb ischemia; infrapopliteal lesions; mortality; nitinol stent; peripheral artery disease; primary stenting; self-expanding stent; target lesion revascularization