title: Experience With the Absorb Everolimus-Eluting Bioresorbable Vascular Scaffold in Arteries Below the Knee: 12-Month Clinical and Imaging Outcomes.
abstract: The aim of this study was to investigate the midterm performance of an everolimus-eluting, bioresorbable vascular scaffold (Absorb, Abbott Vascular, Santa Clara, California) for the treatment of focal tibial and distal popliteal lesions.
  
  
  
  Drug-eluting stents are used below the knee to improve technical success and durability, but the ongoing presence of a permanent metal scaffold may have deleterious effects on the local vessel.
  
  
  
  Tibial and distal popliteal angioplasty with scaffold placement was performed using an everolimus-eluting, bioresorbable scaffold (Absorb). Clinical and ultrasound follow-up was performed at 1, 3, 6, 12, and 24 months to detect binary restenosis and evaluate safety, restenosis, and clinical improvement.
  
  
  
  Thirty-eight limbs in 33 patients were treated for critical limb ischemia (68.4%) or severe claudication (31.6%). Fifty scaffolds were used to treat a total of 43 lesions, with a mean length of 19.2 ± 11.6 mm. During a mean follow-up period of 12.0 ± 3.9 months, 5 patients died, and all others were available for follow-up. Among the 38 treated limbs, clinical improvement was present in 30 (79%). Binary restenosis was detected in 3 of 50 scaffolds (6%). Using the Kaplan-Meier method, rates of primary patency were 96% and 84.6% at 12 and 24 months, respectively, and rates of freedom from clinically driven target lesion revascularization were 96% and 96% at 12 and 24 months, respectively. Complete wound healing occurred in 64% of those treated for tissue loss, with no major amputation and a limb-salvage rate of 100%.
  
  
  
  Twelve-month follow-up demonstrated excellent safety, patency, and freedom from target lesion revascularization using the Absorb bioresorbable vascular scaffold below the knee.
authors.affiliation: Department of Vascular Surgery, Prince of Wales Hospital, Sydney, Australia; Faculty of Medicine, University of New South Wales, Sydney, Australia; The Vascular Institute, Prince of Wales, Sydney, Australia. Electronic address: r.varcoe@unsw.edu.au.
authors.forename: Ramon L
authors.initials: RL
authors.lastname: Varcoe
authors.affiliation: Department of Vascular Surgery, Prince of Wales Hospital, Sydney, Australia; Department of Surgery, Reinier de Graaf Hospital, Delft, the Netherlands.
authors.forename: Olaf
authors.initials: O
authors.lastname: Schouten
authors.affiliation: Department of Vascular Surgery, Prince of Wales Hospital, Sydney, Australia; Faculty of Medicine, University of New South Wales, Sydney, Australia; The Vascular Institute, Prince of Wales, Sydney, Australia.
authors.forename: Shannon D
authors.initials: SD
authors.lastname: Thomas
authors.affiliation: Department of Vascular Surgery, Prince of Wales Hospital, Sydney, Australia; The Vascular Institute, Prince of Wales, Sydney, Australia.
authors.forename: Andrew F
authors.initials: AF
authors.lastname: Lennox
mesh_terms: D020341:Absorbable Implants; D000368:Aged; D000369:Aged, 80 and over; D000792:Angiography; D000800:Angioplasty, Balloon / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D002317:Cardiovascular Agents / Q000008:administration & dosage* / Q000009:adverse effects; D020099:Coated Materials, Biocompatible; D003251:Constriction, Pathologic; D016638:Critical Illness; D000068338:Everolimus / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D007383:Intermittent Claudication / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000628:therapy*; D007511:Ischemia / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000628:therapy*; D053208:Kaplan-Meier Estimate; D007866:Leg / Q000098:blood supply*; D023821:Limb Salvage; D008297:Male; D058729:Peripheral Arterial Disease / Q000000981:diagnostic imaging / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D011150:Popliteal Artery / Q000000981:diagnostic imaging / Q000503:physiopathology; D011237:Predictive Value of Tests; D011446:Prospective Studies; D011474:Prosthesis Design; D012008:Recurrence; D012307:Risk Factors; D016909:Tibial Arteries / Q000000981:diagnostic imaging / Q000503:physiopathology; D013997:Time Factors; D016896:Treatment Outcome; D018615:Ultrasonography, Doppler, Color; D014654:Vascular Patency
chemical_list: D002317:Cardiovascular Agents; D020099:Coated Materials, Biocompatible; D000068338:Everolimus
keywords: absorbable implants; angioplasty; arterial occlusive diseases; ischemia; lower extremity; peripheral arterial disease; polymers; stents