title: Randomized comparison of everolimus-eluting versus bare-metal stents in patients with critical limb ischemia and infrapopliteal arterial occlusive disease.
abstract: OBJECTIVE
  Critical limb ischemia, the most severe form of peripheral arterial disease, results in extremity amputation if left untreated. Endovascular recanalization of stenotic or occluded infrapopliteal arteries has recently emerged as an effective form of therapy, although the duration of patency is typically limited by restenosis. Recently, it has been suggested that drug-eluting stents originally developed for the coronary arteries might also be effective in preventing restenosis in the infrapopliteal arteries. This prospective, randomized, controlled clinical trial tested the hypothesis that treatment of infrapopliteal arterial occlusive lesions with an everolimus-eluting stent (Xience V) would provide superior patency to treatment with a bare-metal stent (Multi-Link Vision).
  
  
  METHODS
  A sample size of 140 patients was planned to be enrolled at five European investigative sites. The primary end point was arterial patency at 12 months, defined as the absence of ≥50% restenosis based on quantitative analysis of contrast angiography.
  
  
  RESULTS
  Between March of 2008 and September of 2009, 74 patients were treated with Xience V and 66 patients were treated with Vision. After 12 months, the primary patency rate after treatment with Xience V was 85% compared with 54% after treatment with Vision (P = .0001). Treatment with Xience V significantly reduced mean in-stent diameter stenosis (21% ± 21% vs 47% ± 27%; P < .0001) and mean in-stent late lumen loss (0.78 ± 0.63 vs 1.41 ± 0.89 mm; P = .001). There were no differences in the percentage of patients receiving a designation of Rutherford class 0 or 1 at the 12-month follow-up visit (56% for Vision, vs 60% for Xience V; P = .68). Major extremity amputations were rare in both groups (two for Vision and one for Xience V). The use of the Xience V stent significantly reduced the need for repeat intervention: freedom from target lesion revascularization was 91% for Xience V vs 66% for Vision (P = .001).
  
  
  CONCLUSIONS
  Treatment of the infrapopliteal occlusive lesions of critical limb ischemia with everolimus-eluting stents reduces restenosis and the need for reintervention compared with bare metal stents.
authors.affiliation: Department of Vascular Surgery, AZ Sint-Blasius, Dendermonde, Belgium. marc.bosiers@telenet.be
authors.forename: Marc
authors.initials: M
authors.lastname: Bosiers
authors.forename: Dierk
authors.initials: D
authors.lastname: Scheinert
authors.forename: Patrick
authors.initials: P
authors.lastname: Peeters
authors.forename: Giovanni
authors.initials: G
authors.lastname: Torsello
authors.forename: Thomas
authors.initials: T
authors.lastname: Zeller
authors.forename: Koen
authors.initials: K
authors.lastname: Deloose
authors.forename: Andrej
authors.initials: A
authors.lastname: Schmidt
authors.forename: Jörg
authors.initials: J
authors.lastname: Tessarek
authors.forename: Erwin
authors.initials: E
authors.lastname: Vinck
authors.forename: Lewis B
authors.initials: LB
authors.lastname: Schwartz
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000671:Amputation, Surgical; D017130:Angioplasty / Q000009:adverse effects / Q000295:instrumentation*; D001157:Arterial Occlusive Diseases / Q000150:complications / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000628:therapy*; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D003251:Constriction, Pathologic; D016638:Critical Illness; D054855:Drug-Eluting Stents; D005060:Europe; D000068338:Everolimus; D005260:Female; D006801:Humans; D007511:Ischemia / Q000000981:diagnostic imaging / Q000209:etiology / Q000503:physiopathology / Q000628:therapy*; D053208:Kaplan-Meier Estimate; D023821:Limb Salvage; D008297:Male; D008670:Metals; D008875:Middle Aged; D011150:Popliteal Artery / Q000000981:diagnostic imaging / Q000503:physiopathology; D011446:Prospective Studies; D011474:Prosthesis Design; D011859:Radiography; D012008:Recurrence; 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