title: One-Year Outcomes Following Directional Atherectomy of Infrapopliteal Artery Lesions: Subgroup Results of the Prospective, Multicenter DEFINITIVE LE Trial.
abstract: OBJECTIVE
  To report a subgroup analysis of the prospective, multicenter, single-arm DEFINITIVE LE trial to assess the effectiveness of directional atherectomy for the treatment of infrapopliteal artery lesions at 1 year.
  
  
  METHODS
  In the DEFINITIVE LE trial, follow-up assessments occurred up to 1 year postprocedure. Of the 800 patients enrolled, 145 subjects with 189 infrapopliteal lesions met the criteria for this analysis. Seventy (48.3%) and 75 (51.7%) patients were suffering critical limb ischemia (CLI) and intermittent claudication, respectively; 68.3% (99/145) had diabetes. The mean lesion length was 58±44 mm (all lesions); 20.2% were occluded. The primary endpoint for patients with claudication was duplex ultrasound-derived primary patency, while for subjects with CLI it was freedom from major amputation of the target limb at 1 year. Endpoints and adverse events were independently assessed.
  
  
  RESULTS
  Procedure success (≤30% residual stenosis) was achieved in 84% of treated lesions. The 1-year primary patency rate was 84% (claudicants 89.6% and CLI patients 78%, p=0.11), and the freedom from major amputation rate was 97.1% (claudicants 100% and CLI 93.8%, p=0.03). In both claudication and CLI patients, significant improvements in Rutherford category and objective measures of walking distance and quality of life were seen at 1 year in comparison to baseline.
  
  
  CONCLUSIONS
  This study demonstrates that directional atherectomy in infrapopliteal arteries results in promising technical and clinical results at 1 year for claudicant as well as CLI patients.
authors.affiliation: Kardiologie und Angiologie II, Universitäts-Herzzentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany aljoscha.rastan@universitaets-herzzentrum.de.
authors.forename: Aljoscha
authors.initials: A
authors.lastname: Rastan
authors.affiliation: Division of Vascular Surgery, New York Presbyterian Hospital, University Hospital of Columbia and Cornell, New York, NY, USA.
authors.forename: James F
authors.initials: JF
authors.lastname: McKinsey
authors.affiliation: Sections of Interventional Cardiology and Vascular Medicine, St. Elizabeth's Medical Center, Tufts University School of Medicine, Boston, MA, USA.
authors.forename: Lawrence A
authors.initials: LA
authors.lastname: Garcia
authors.affiliation: The Prairie Heart Institute at St. John's Hospital, Springfield, IL, USA.
authors.forename: Krishna J
authors.initials: KJ
authors.lastname: Rocha-Singh
authors.affiliation: The Institute for Heart, Vascular and Stroke Care, Massachusetts General Hospital, Boston, MA, USA.
authors.forename: Michael R
authors.initials: MR
authors.lastname: Jaff
authors.affiliation: Kardiologie und Angiologie II, Universitäts-Herzzentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany.
authors.forename: Elias
authors.initials: E
authors.lastname: Noory
authors.affiliation: Kardiologie und Angiologie II, Universitäts-Herzzentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Zeller
mesh_terms: D000368:Aged; D001157:Arterial Occlusive Diseases / Q000601:surgery*; D017073:Atherectomy / Q000379:methods*; D057510:Endovascular Procedures; D005260:Female; D006801:Humans; D008297:Male; D011150:Popliteal Artery / Q000601:surgery*; D011446:Prospective Studies; D013997:Time Factors; D016896:Treatment Outcome
keywords: angioplasty; atherectomy; claudication; critical limb ischemia; infrapopliteal arteries; patency; peripheral artery disease; peroneal artery; restenosis; tibial artery