title: Major adverse limb events and wound healing following infrapopliteal artery stent implantation in patients with critical limb ischemia: the XCELL trial.
abstract: BACKGROUND
  Percutaneous transluminal angioplasty (PTA) with stent deployment of infrapopliteal arteries is an accepted but unproven therapy for patients with critical limb ischemia (CLI). We evaluated the safety and effectiveness of the Xpert™ self-expanding nitinol stent (Abbott Vascular, Redwood City, CA) in Rutherford Class 4-6 subjects with infrapopliteal lesions of 4-15 cm in length.
  
  
  RESULTS
  120 patients (140 limbs, 212 implanted devices) underwent primary infrapopliteal nitinol stent deployment as part of this multicenter registry. The primary endpoint was 12-month amputation-free survival (AFS); secondary endpoints included limb salvage, target lesion revascularization (TLR), 6- month angiographic patency, and 6- and 12-month outcomes of wound healing and pain relief. Despite a 6-month binary stent restenosis rate of 68.5%, the 12-month AFS rate was 78.3%. Stratified according to baseline Rutherford classes 4, 5 and 6, the 12-month AFS rates were 100%, 77.3%, and 55.2%, respectively, and freedom from major amputation rates were 100%, 90.9%, and 70.1%, respectively. The 12-month freedom from major amputation rate and clinically driven TLR were 89.6% and 70.1%, respectively. The 6- and 12-month complete wound-healing rates were 49.0% and 54.4%, respectively. Rutherford class 4 patients had significant pain relief through 12-months (P<0.05).
  
  
  CONCLUSIONS
  Primary infrapopliteal nitinol stenting to treat CLI is safe and effective in improving 6-and 12-month clinical outcomes.
authors.affiliation: Prairie Education and Research Cooperative, St. John's Hospital, Springfield, IL, USA. ksingh@prairieheart.com
authors.forename: Krishna J
authors.initials: KJ
authors.lastname: Rocha-Singh
authors.forename: Michael
authors.initials: M
authors.lastname: Jaff
authors.forename: James
authors.initials: J
authors.lastname: Joye
authors.forename: John
authors.initials: J
authors.lastname: Laird
authors.forename: Gary
authors.initials: G
authors.lastname: Ansel
authors.forename: Peter
authors.initials: P
authors.lastname: Schneider
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000497:Alloys; D000671:Amputation, Surgical; D000800:Angioplasty, Balloon / Q000009:adverse effects* / Q000295:instrumentation* / Q000401:mortality; D003251:Constriction, Pathologic; D016638:Critical Illness; D005260:Female; D006801:Humans; D007511:Ischemia / Q000209:etiology / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D053208:Kaplan-Meier Estimate; D023821:Limb Salvage; D035002:Lower Extremity / Q000098:blood supply*; D008297:Male; D010146:Pain / Q000209:etiology; D058729:Peripheral Arterial Disease / Q000150:complications / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D011150:Popliteal Artery / Q000503:physiopathology; D011446:Prospective Studies; D011474:Prosthesis Design; D012008:Recurrence; D012042:Registries; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology; D014654:Vascular Patency; D014945:Wound Healing
chemical_list: D000497:Alloys; C013616:nitinol