title: Lower extremity revascularization using directional atherectomy: 12-month prospective results of the DEFINITIVE LE study.
abstract: OBJECTIVE
  The aim of this study was to assess the safety and effectiveness of directional atherectomy (DA) for endovascular treatment of peripheral arterial disease (PAD) in infrainguinal arteries in patients with claudication or critical limb ischemia.
  
  
  BACKGROUND
  To date, no prospective, multicenter, independently-adjudicated study has evaluated the effectiveness and durability of DA in the treatment of PAD. Previous DA studies have not been prospectively powered to evaluate any differences in outcomes in patients with and without diabetes.
  
  
  METHODS
  DEFINITIVE LE (Determination of EFfectiveness of the SilverHawk(®) PerIpheral Plaque ExcisioN System (SIlverHawk Device) for the Treatment of Infrainguinal VEssels / Lower Extremities) prospectively enrolled subjects at 47 multinational centers with an infrainguinal lesion length up to 20 cm. Primary endpoints were defined as primary patency at 12 months for claudicants and freedom from major unplanned amputation for critical limb ischemia (CLI) subjects. A pre-specified statistical hypothesis evaluated noninferiority of primary patency in diabetic versus nondiabetic claudicants. Independent angiographic and sonographic core laboratories assessed outcomes, and events were adjudicated by a clinical events committee.
  
  
  RESULTS
  A total of 800 subjects were enrolled. The 12-month primary patency was 78% (95% confidence interval: 74.0% to 80.6%) in claudicants, with a 77% rate in the diabetic subgroup versus 78% in the nondiabetic subgroup (noninferior, p < 0.001). The rate of freedom from major unplanned amputation of the target limb at 12 months in CLI subjects was 95% (95% confidence interval: 90.7% to 97.4%). Periprocedural adverse events included embolization (3.8%), perforation (5.3%), and abrupt closure (2.0%). The bail-out stent rate was 3.2%.
  
  
  CONCLUSIONS
  The DEFINITIVE LE study demonstrated that DA is a safe and effective treatment modality at 12 months for a diverse patient population with either claudication or CLI. Furthermore, DA was shown to be noninferior for treating PAD in patients with diabetes compared with those without diabetes. (Study of SilverHawk/TurboHawk in Lower Extremity Vessels [DEFINITIVE LE]; NCT00883246).
authors.affiliation: Division of Vascular Surgery, New York Presbyterian Hospital, University Hospital of Columbia and Cornell, New York, New York. Electronic address: jmckinsey@chpnet.org.
authors.forename: James F
authors.initials: JF
authors.lastname: McKinsey
authors.affiliation: Universitäts-Herzzentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Zeller
authors.affiliation: Prairie Heart Institute at St. John's Hospital, Springfield, Illinois.
authors.forename: Krishna J
authors.initials: KJ
authors.lastname: Rocha-Singh
authors.affiliation: Institute for Heart, Vascular, and Stroke Care, Massachusetts General Hospital, Boston, Massachusetts.
authors.forename: Michael R
authors.initials: MR
authors.lastname: Jaff
authors.affiliation: Sections of Interventional Cardiology and Vascular Medicine, St. Elizabeth's Medical Center, Tufts University School of Medicine, Boston, Massachusetts.
authors.forename: Lawrence A
authors.initials: LA
authors.lastname: Garcia
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000671:Amputation, Surgical; D000800:Angioplasty, Balloon / Q000295:instrumentation; D017073:Atherectomy / Q000009:adverse effects / Q000295:instrumentation; D015897:Comorbidity; D016638:Critical Illness; D018572:Disease-Free Survival; D004867:Equipment Design; D005260:Female; D006801:Humans; D007383:Intermittent Claudication / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D007511:Ischemia / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D053208:Kaplan-Meier Estimate; D023821:Limb Salvage; D035002:Lower Extremity / Q000098:blood supply*; D008297:Male; D008875:Middle Aged; D058729:Peripheral Arterial Disease / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D011446:Prospective Studies; D012008:Recurrence; D012307:Risk Factors; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome; D014654:Vascular Patency
keywords: angioplasty; atherectomy; claudication; critical limb ischemia; peripheral artery disease