title: A Comparison of Clinical Outcomes for Diabetic and Nondiabetic Patients Following Directional Atherectomy in the DEFINITIVE LE Claudicant Cohort.
abstract: OBJECTIVE
  To report a subset analysis that evaluated the hypothesis that directional atherectomy for peripheral artery disease in diabetic claudicants has noninferior primary patency at 12 months compared with nondiabetic claudicants.
  
  
  METHODS
  DEFINITIVE LE, a US/European multicenter study, assessed the effectiveness of directional atherectomy using SilverHawk/TurboHawk systems for treatment of peripheral artery disease in the superficial femoral, popliteal, and infrapopliteal arteries. Of the 800 patients enrolled in the study, only the 598 claudicant patients (mean age 69.5±10.4 years; 336 men) who were classified at baseline as Rutherford category 1-3 were eligible for this subset analysis. Of these, 46.8% (280/598) had diabetes. Follow-up to 12 months included duplex ultrasound examination, functional assessments, and adverse event evaluations. Independent angiographic and duplex ultrasound core laboratories assessed primary patency and secondary endpoints; a clinical events committee adjudicated adverse events.
  
  
  RESULTS
  Although diabetics had significantly more baseline comorbidities, 12-month primary patency (77.0%) was no different than for nondiabetics (77.9%; superiority p=0.98; noninferiority p<0.001) across all anatomic territories treated. Freedom from clinically driven target lesion revascularization was no different between diabetics (83.8%) and nondiabetics (87.5%) overall (p=0.19) or by lesion locations. Secondary clinical outcomes (Rutherford category, ankle-brachial index, and walking impairment) improved at 12 months for both diabetics and nondiabetics.
  
  
  CONCLUSIONS
  Noninferior 12-month patency rates demonstrate that directional atherectomy is an effective treatment in diabetic as well as nondiabetic claudicants. Directional atherectomy remains an attractive treatment option, improving luminal diameters without stents, which preserves future treatment options for both diabetic and nondiabetic patients with progressive, diffuse vascular disease.
authors.affiliation: Sections of Interventional Cardiology and Vascular Medicine, St. Elizabeth's Medical Center, Tufts University School of Medicine, Boston, MA, USA Lawrence.garcia@steward.org.
authors.forename: Lawrence A
authors.initials: LA
authors.lastname: Garcia
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: 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: Universitäts-Herzzentrum Freiburg, Bad Krozingen, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Zeller
authors.affiliation: Coastal Vascular and Interventional, Pensacola, FL, USA.
authors.forename: Christopher
authors.initials: C
authors.lastname: Bosarge
authors.affiliation: Christus Spohn Hospital Alice, Alice, TX, USA.
authors.forename: Suraj
authors.initials: S
authors.lastname: Kamat
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
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D055109:Ankle Brachial Index; D017073:Atherectomy / Q000009:adverse effects / Q000379:methods*; D003251:Constriction, Pathologic; D003925:Diabetic Angiopathies / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D018572:Disease-Free Survival; D005060:Europe; D017079:Exercise Tolerance; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging / Q000503:physiopathology; D006801:Humans; D007383:Intermittent Claudication / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; 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; D011859:Radiography; D020127:Recovery of Function; D012042:Registries; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome; D018616:Ultrasonography, Doppler, Duplex; D014481:United States; D014654:Vascular Patency
keywords: atherectomy; claudication; diabetes mellitus; directional atherectomy; infrapopliteal arteries; patency; peripheral artery disease; popliteal artery; superficial femoral artery; target lesion revascularization