title: Drug-Coated Balloon Versus Standard Balloon for Superficial Femoral Artery In-Stent Restenosis: The Randomized Femoral Artery In-Stent Restenosis (FAIR) Trial.
abstract: BACKGROUND
  Drug-coated balloon angioplasty (DCBA) was shown to be superior to standard balloon angioplasty (POBA) in terms of restenosis prevention for de novo superficial femoral artery disease. For in-stent restenosis, the benefit of DCBA over POBA remains uncertain.
  
  
  RESULTS
  One hundred nineteen patients with superficial femoral artery in-stent restenosis and chronic limb ischemia were recruited over 34 months at 5 German clinical sites and prospectively randomized to either DCBA (n=62) or POBA (n=57). Mean lesion length was 82.2±68.4 mm. Thirty-four (28.6%) lesions were totally occluded; 30 (25.2%) were moderately or heavily calcified. Clinical and duplex ultrasound follow-up was conducted at 6 and 12 months. The primary end point of recurrent in-stent restenosis assessed by ultrasound at 6 months was 15.4% (8 of 52) in the DCBA and 44.7% (21 of 47) in the POBA group (P=0.002). Freedom from target lesion revascularization was 96.4% versus 81.0% (P=0.0117) at 6 months and 90.8% versus 52.6% (P<0.0001) at 12 months, respectively. At 12 months, clinical improvement by ≥1 Rutherford category without the need for target lesion revascularization was observed in 35 of 45 DCBA patients (77.8%) and 23 of 44 POBA patients (52.3%; P=0.015). No major amputation was needed. Two patients in the DCBA and 3 patients in the POBA group died. No death was procedure related.
  
  
  CONCLUSIONS
  DCBA for superficial femoral artery in-stent restenosis is associated with less recurrent restenosis and a better clinical outcome than POBA without an apparent difference in safety.
  
  
  BACKGROUND
  URL: http://www.clinicaltrials.gov. Unique identifier: NCT01305070.
authors.affiliation: From the Department of Angiology, Cardiovascular Center Bad Bevensen, Bad Bevensen, Germany (H.K., M.I.); Medtronic, Meerbusch, Germany (T.T.); Asklepios Proresearch, Hamburg, Germany (M.S.); University of Leipzig Heart Center, Leipzig, Germany (D.S.); Department of Internal Medicine, SHR Clinic Karlsbad-Langensteinbach, Karlsbad-Langensteinbach, Germany (E.B.); Hamburg University Cardiovascular Center, Hamburg, Germany (S.S.); Department of Angiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany (A.K.); and Department of Angiology, Heart Center Bad Krozingen, Bad Krozingen, Germany (U.B., T.Z.). h.krankenberg@hgz-bb.de.
authors.forename: Hans
authors.initials: H
authors.lastname: Krankenberg
authors.affiliation: From the Department of Angiology, Cardiovascular Center Bad Bevensen, Bad Bevensen, Germany (H.K., M.I.); Medtronic, Meerbusch, Germany (T.T.); Asklepios Proresearch, Hamburg, Germany (M.S.); University of Leipzig Heart Center, Leipzig, Germany (D.S.); Department of Internal Medicine, SHR Clinic Karlsbad-Langensteinbach, Karlsbad-Langensteinbach, Germany (E.B.); Hamburg University Cardiovascular Center, Hamburg, Germany (S.S.); Department of Angiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany (A.K.); and Department of Angiology, Heart Center Bad Krozingen, Bad Krozingen, Germany (U.B., T.Z.).
authors.forename: Thilo
authors.initials: T
authors.lastname: Tübler
authors.affiliation: From the Department of Angiology, Cardiovascular Center Bad Bevensen, Bad Bevensen, Germany (H.K., M.I.); Medtronic, Meerbusch, Germany (T.T.); Asklepios Proresearch, Hamburg, Germany (M.S.); University of Leipzig Heart Center, Leipzig, Germany (D.S.); Department of Internal Medicine, SHR Clinic Karlsbad-Langensteinbach, Karlsbad-Langensteinbach, Germany (E.B.); Hamburg University Cardiovascular Center, Hamburg, Germany (S.S.); Department of Angiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany (A.K.); and Department of Angiology, Heart Center Bad Krozingen, Bad Krozingen, Germany (U.B., T.Z.).
authors.forename: Maja
authors.initials: M
authors.lastname: Ingwersen
authors.affiliation: From the Department of Angiology, Cardiovascular Center Bad Bevensen, Bad Bevensen, Germany (H.K., M.I.); Medtronic, Meerbusch, Germany (T.T.); Asklepios Proresearch, Hamburg, Germany (M.S.); University of Leipzig Heart Center, Leipzig, Germany (D.S.); Department of Internal Medicine, SHR Clinic Karlsbad-Langensteinbach, Karlsbad-Langensteinbach, Germany (E.B.); Hamburg University Cardiovascular Center, Hamburg, Germany (S.S.); Department of Angiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany (A.K.); and Department of Angiology, Heart Center Bad Krozingen, Bad Krozingen, Germany (U.B., T.Z.).
authors.forename: Michael
authors.initials: M
authors.lastname: Schlüter
authors.affiliation: From the Department of Angiology, Cardiovascular Center Bad Bevensen, Bad Bevensen, Germany (H.K., M.I.); Medtronic, Meerbusch, Germany (T.T.); Asklepios Proresearch, Hamburg, Germany (M.S.); University of Leipzig Heart Center, Leipzig, Germany (D.S.); Department of Internal Medicine, SHR Clinic Karlsbad-Langensteinbach, Karlsbad-Langensteinbach, Germany (E.B.); Hamburg University Cardiovascular Center, Hamburg, Germany (S.S.); Department of Angiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany (A.K.); and Department of Angiology, Heart Center Bad Krozingen, Bad Krozingen, Germany (U.B., T.Z.).
authors.forename: Dierk
authors.initials: D
authors.lastname: Scheinert
authors.affiliation: From the Department of Angiology, Cardiovascular Center Bad Bevensen, Bad Bevensen, Germany (H.K., M.I.); Medtronic, Meerbusch, Germany (T.T.); Asklepios Proresearch, Hamburg, Germany (M.S.); University of Leipzig Heart Center, Leipzig, Germany (D.S.); Department of Internal Medicine, SHR Clinic Karlsbad-Langensteinbach, Karlsbad-Langensteinbach, Germany (E.B.); Hamburg University Cardiovascular Center, Hamburg, Germany (S.S.); Department of Angiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany (A.K.); and Department of Angiology, Heart Center Bad Krozingen, Bad Krozingen, Germany (U.B., T.Z.).
authors.forename: Erwin
authors.initials: E
authors.lastname: Blessing
authors.affiliation: From the Department of Angiology, Cardiovascular Center Bad Bevensen, Bad Bevensen, Germany (H.K., M.I.); Medtronic, Meerbusch, Germany (T.T.); Asklepios Proresearch, Hamburg, Germany (M.S.); University of Leipzig Heart Center, Leipzig, Germany (D.S.); Department of Internal Medicine, SHR Clinic Karlsbad-Langensteinbach, Karlsbad-Langensteinbach, Germany (E.B.); Hamburg University Cardiovascular Center, Hamburg, Germany (S.S.); Department of Angiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany (A.K.); and Department of Angiology, Heart Center Bad Krozingen, Bad Krozingen, Germany (U.B., T.Z.).
authors.forename: Sebastian
authors.initials: S
authors.lastname: Sixt
authors.affiliation: From the Department of Angiology, Cardiovascular Center Bad Bevensen, Bad Bevensen, Germany (H.K., M.I.); Medtronic, Meerbusch, Germany (T.T.); Asklepios Proresearch, Hamburg, Germany (M.S.); University of Leipzig Heart Center, Leipzig, Germany (D.S.); Department of Internal Medicine, SHR Clinic Karlsbad-Langensteinbach, Karlsbad-Langensteinbach, Germany (E.B.); Hamburg University Cardiovascular Center, Hamburg, Germany (S.S.); Department of Angiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany (A.K.); and Department of Angiology, Heart Center Bad Krozingen, Bad Krozingen, Germany (U.B., T.Z.).
authors.forename: Arne
authors.initials: A
authors.lastname: Kieback
authors.affiliation: From the Department of Angiology, Cardiovascular Center Bad Bevensen, Bad Bevensen, Germany (H.K., M.I.); Medtronic, Meerbusch, Germany (T.T.); Asklepios Proresearch, Hamburg, Germany (M.S.); University of Leipzig Heart Center, Leipzig, Germany (D.S.); Department of Internal Medicine, SHR Clinic Karlsbad-Langensteinbach, Karlsbad-Langensteinbach, Germany (E.B.); Hamburg University Cardiovascular Center, Hamburg, Germany (S.S.); Department of Angiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany (A.K.); and Department of Angiology, Heart Center Bad Krozingen, Bad Krozingen, Germany (U.B., T.Z.).
authors.forename: Ulrich
authors.initials: U
authors.lastname: Beschorner
authors.affiliation: From the Department of Angiology, Cardiovascular Center Bad Bevensen, Bad Bevensen, Germany (H.K., M.I.); Medtronic, Meerbusch, Germany (T.T.); Asklepios Proresearch, Hamburg, Germany (M.S.); University of Leipzig Heart Center, Leipzig, Germany (D.S.); Department of Internal Medicine, SHR Clinic Karlsbad-Langensteinbach, Karlsbad-Langensteinbach, Germany (E.B.); Hamburg University Cardiovascular Center, Hamburg, Germany (S.S.); Department of Angiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany (A.K.); and Department of Angiology, Heart Center Bad Krozingen, Bad Krozingen, Germany (U.B., T.Z.).
authors.forename: Thomas
authors.initials: T
authors.lastname: Zeller
mesh_terms: D000368:Aged; D000800:Angioplasty, Balloon / Q000379:methods*; D005260:Female; D005263:Femoral Artery / Q000187:drug effects / Q000473:pathology*; D006083:Graft Occlusion, Vascular / Q000175:diagnosis* / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage*; D011446:Prospective Studies; D015607:Stents / Q000009:adverse effects*
chemical_list: D017239:Paclitaxel
keywords: angioplasty; angioplasty, balloon; coronary restenosis; peripheral arterial disease; randomized controlled trial