title: Everolimus-Eluting Stent for Patients With Critical Limb Ischemia and Infrapopliteal Arterial Occlusive Disease.
abstract: BACKGROUND
  Critical limb ischemia (CLI), despite revascularization, may result in minor or major amputations with devastating psychological effects and a negative impact on patient survival. Randomized clinical trials demonstrated that drug-eluting stents improve 1-year primary patency and decrease target lesion revascularization, compared to standard angioplasty and bare-metal stents, in patients with short occlusive below-the-knee lesions.
  
  
  OBJECTIVE
  This prospective clinical study was designed to evaluate if one straight-line flow revascularization to the foot, using Xience-Prime Everolimus-Eluting Stent (EES), is an effective treatment of patients in Rutherford-Becker category 4 to 5 with distal popliteal and proximal tibial arteries long occlusive lesions up to 10 cm.
  
  
  METHODS
  All patients with angiographic documented segment P3 of popliteal artery and proximal tibial arteries stenosis >70%, and lesion length between 20 mm and 100 mm, meeting the inclusion criteria, were included in the Etna Registry. The end points assessed were 1- and 3-year primary patency, major amputation-free survival, target lesion revascularization, and wound healing rates.
  
  
  RESULTS
  Between June 2011 and April 2014, 122 patients were included in the study, with mean lesion length of 52.7 mm (range: 20-100 mm). The 1- and 3-year primary patency rates were 88.9% and 80.1%, respectively. The survival, major amputation-free survival, and target lesion revascularization rates were 88.1%, 93%, and 91.5% at 1-year and 70.4%, 89.3%, and 85.1% at 3-year follow-up, respectively. Primary patency influenced major amputation rate, which was 60% in patients with no target artery patency versus 5.4% in patients with patency ( P = .022). At 1-year follow-up, 78 (88.6%) of 88 patients improved 1 or more of their Rutherford-Becker category, and 48 (80%) of 69 patients had wound healing.
  
  
  CONCLUSIONS
  The results of our study suggest that a conservative approach, with EES, seems feasible in selected patients with CLI and infrapopliteal artery occlusive disease.
authors.affiliation: 1 Vascular Surgery and Organ Transplant Unit, Department of Medical and Surgical Sciences and Advanced Technologies, University Hospital of Catania, Catania, Italy.
authors.forename: Alessia
authors.initials: A
authors.lastname: Giaquinta
authors.affiliation: 1 Vascular Surgery and Organ Transplant Unit, Department of Medical and Surgical Sciences and Advanced Technologies, University Hospital of Catania, Catania, Italy.
authors.forename: Ardita
authors.initials: A
authors.lastname: Vincenzo
authors.affiliation: 1 Vascular Surgery and Organ Transplant Unit, Department of Medical and Surgical Sciences and Advanced Technologies, University Hospital of Catania, Catania, Italy.
authors.forename: Ester
authors.initials: E
authors.lastname: De Marco
authors.affiliation: 1 Vascular Surgery and Organ Transplant Unit, Department of Medical and Surgical Sciences and Advanced Technologies, University Hospital of Catania, Catania, Italy.
authors.forename: Massimiliano
authors.initials: M
authors.lastname: Veroux
authors.affiliation: 1 Vascular Surgery and Organ Transplant Unit, Department of Medical and Surgical Sciences and Advanced Technologies, University Hospital of Catania, Catania, Italy.
authors.forename: Pierfrancesco
authors.initials: P
authors.lastname: Veroux
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000671:Amputation, Surgical; D000792:Angiography; D000800:Angioplasty, Balloon / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D003251:Constriction, Pathologic; D016638:Critical Illness; D018572:Disease-Free Survival; D054855:Drug-Eluting Stents; D000068338:Everolimus / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D007511:Ischemia / Q000000981:diagnostic imaging / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D007558:Italy; D053208:Kaplan-Meier Estimate; D023821:Limb Salvage; D008297:Male; D008875:Middle Aged; D058729:Peripheral Arterial Disease / Q000000981:diagnostic imaging / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D011150:Popliteal Artery / Q000000981:diagnostic imaging / Q000503:physiopathology; D011446:Prospective Studies; D011474:Prosthesis Design; D012008:Recurrence; D012042:Registries; D012307:Risk Factors; D016909:Tibial Arteries / Q000000981:diagnostic imaging / Q000503:physiopathology; D013997:Time Factors; D016896:Treatment Outcome; D014654:Vascular Patency; D014945:Wound Healing
chemical_list: D002317:Cardiovascular Agents; D000068338:Everolimus
keywords: Everolimus; below the knee; critical limb ischemia; drug-eluting stent; patency; peripheral arterial disease