title: First experience with drug-eluting balloons in infrapopliteal arteries: restenosis rate and clinical outcome.
abstract: OBJECTIVE
  The purpose of this study was to investigate the efficacy of drug-eluting balloons (DEBs) in the treatment of long infrapopliteal lesions with regard to the short-term restenosis rate and midterm clinical result.
  
  
  BACKGROUND
  Restenosis rates of long-segment tibial artery disease are very high. Recently, a restenosis rate of 69% at 3 months after standard balloon angioplasty was demonstrated.
  
  
  METHODS
  Infrapopliteal angioplasty was performed with a paclitaxel-eluting balloon (In.Pact Amphirion, Medtronic, Minneapolis, Minnesota). Clinical and angiographic follow-up was performed at 3 months to detect binary restenosis, and further clinical assessment was performed over a 12-month period thereafter.
  
  
  RESULTS
  In 104 patients, 109 limbs were treated for critical limb ischemia (82.6%) or severe claudication (17.4%). Mean lesion length of the arteries treated was 176 ± 88 mm. Angiography studied in 84 treated arteries at 3 months showed a restenosis in 27.4% (19.1% had restenosis of more than 50%, and 8.3% were totally occluded) and usually occurred focally. Only in 9.5% of all angiographically followed up arteries was the entire treated segment restenosed or reoccluded. During a follow-up period of 378 ± 65 days, 1 patient was lost and 17 died. Of the 91 limbs remaining in the analysis, clinical improvement was present in 83 (91.2%). Complete wound healing occurred in 74.2%, whereas major amputation occurred in 4 patients, resulting in limb salvage of 95.6% for patients with critical limb ischemia.
  
  
  CONCLUSIONS
  The early restenosis rate of long-segment infrapopliteal disease is significantly lower after treatment with DEBs compared with historical data using uncoated balloons. Randomized trials are required to show whether this difference will lead to improvement in clinical outcomes.
authors: Center of Vascular Medicine, Angiology and Vascular Surgery, Park Hospital Leipzig, Strümpellstrasse 41, Leipzig,Germany. andrej.schmidt@gmx.de
authors: Andrej
authors: A
authors: Schmidt
authors: Michael
authors: M
authors: Piorkowski
authors: Martin
authors: M
authors: Werner
authors: Matthias
authors: M
authors: Ulrich
authors: Yvonne
authors: Y
authors: Bausback
authors: Sven
authors: S
authors: Bräunlich
authors: Henrik
authors: H
authors: Ick
authors: Johannes
authors: J
authors: Schuster
authors: Spiridon
authors: S
authors: Botsios
authors: Hans-Joachim
authors: HJ
authors: Kruse
authors: Ramon L
authors: RL
authors: Varcoe
authors: Dierk
authors: D
authors: Scheinert
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000792:Angiography; D000800:Angioplasty, Balloon; D003251:Constriction, Pathologic; D005260:Female; D006801:Humans; D007511:Ischemia / Q000000981:diagnostic imaging / Q000628:therapy*; D007866:Leg / Q000098:blood supply*; D023821:Limb Salvage; D008297:Male; D011150:Popliteal Artery / Q000473:pathology / Q000601:surgery; D012008:Recurrence; D016896:Treatment Outcome