title: Primary everolimus-eluting stenting versus balloon angioplasty with bailout bare metal stenting of long infrapopliteal lesions for treatment of critical limb ischemia.
abstract: OBJECTIVE
  To report the long-term outcomes of a single-center prospective study investigating primary placement of everolimus-eluting metal stents for recanalization of long infrapopliteal lesions compared to a matched historical control group treated with plain balloon angioplasty and provisional placement of bare metal stents in a bailout manner.
  
  
  METHODS
  The study included 81 patients (63 men; mean age 71 years, range 45-85) suffering from critical limb ischemia (CLI) and angiographically proven long-segment (at least 1 lesion >4.5 cm) de novo infrapopliteal artery disease who underwent below-the-knee revascularization with either primary placement of everolimus-eluting stents (n = 47, 51 limbs, 102 lesions) or angioplasty and bailout bare metal stenting (n = 34, 36 limbs, 72 lesions). Clinical and angiographic follow-up was collected at regular time intervals. Primary clinical and angiographic endpoints included patient survival, major amputation-free survival, angiographic primary patency, angiographic binary restenosis (>50%), and overall event-free survival. Results were stratified according to endovascular treatment received. Multivariable Cox proportional hazards regression analysis was applied to adjust for confounding factors of heterogeneity.
  
  
  RESULTS
  Baseline demographics were well matched. No significant differences were identified between the 2 groups with regard to overall 3-year patient survival (82.2% versus 65.7%; p = 0.90) and amputation-free survival (77.1% versus 86.9%; p = 0.20). Up to 3 years, lesions fully covered with everolimus-eluting stents were associated with significantly higher primary patency [hazard ratio (HR) 7.98, 95% CI 3.69 to 17.25, p < 0.0001], reduced binary restenosis (HR 2.94, 95% CI 1.74 to 4.99, p < 0.0001), and improved overall event-free survival (HR 2.19, 95% CI 1.16 to 4.13, p = 0.015) versus the matched historical control group.
  
  
  CONCLUSIONS
  Primary infrapopliteal everolimus-eluting stenting for CLI treatment significantly inhibits restenosis and improves long-term angiographic patency and overall patient event-free survival compared to balloon angioplasty and bailout bare metal stenting.
authors.affiliation: Department of Interventional Radiology, Patras University Hospital, School of Medicine, Rion, Greece. karnaby@upatras.gr
authors.forename: Dimitris
authors.initials: D
authors.lastname: Karnabatidis
authors.forename: Stavros
authors.initials: S
authors.lastname: Spiliopoulos
authors.forename: Athanasios
authors.initials: A
authors.lastname: Diamantopoulos
authors.forename: Konstantinos
authors.initials: K
authors.lastname: Katsanos
authors.forename: George C
authors.initials: GC
authors.lastname: Kagadis
authors.forename: Stavros
authors.initials: S
authors.lastname: Kakkos
authors.forename: Dimitris
authors.initials: D
authors.lastname: Siablis
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000671:Amputation, Surgical; D000800:Angioplasty, Balloon / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D001157:Arterial Occlusive Diseases / Q000150:complications / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D003251:Constriction, Pathologic; D016638:Critical Illness; D018572:Disease-Free Survival; D054855:Drug-Eluting Stents; D000068338:Everolimus; D005260:Female; D006115:Greece; D006801:Humans; D007511:Ischemia / Q000000981:diagnostic imaging / Q000209:etiology / Q000401:mortality / Q000628:therapy*; D053208:Kaplan-Meier Estimate; D035002:Lower Extremity / Q000098:blood supply*; D008297:Male; D008670:Metals; D008875:Middle Aged; D011150:Popliteal Artery / Q000000981:diagnostic imaging / Q000503:physiopathology; D016016:Proportional Hazards Models; D011446:Prospective Studies; D011859:Radiography; D018570:Risk Assessment; D012307:Risk Factors; D020123:Sirolimus / Q000008:administration & dosage / Q000031:analogs & derivatives*; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome; D014654:Vascular Patency
chemical_list: D002317:Cardiovascular Agents; D008670:Metals; D000068338:Everolimus; D020123:Sirolimus