title: Evaluation of the Biodegradable Igaki-Tamai Scaffold After Drug-Eluting Balloon Treatment of De Novo Superficial Femoral Artery Lesions: The GAIA-DEB Study.
abstract: OBJECTIVE
  To evaluate the safety and efficacy of the Igaki-Tamai biodegradable scaffold after drug-eluting balloon (DEB) angioplasty in patients with occlusive superficial femoral artery (SFA) disease.
  
  
  METHODS
  A prospective, single-center, nonrandomized study enrolled 20 patients (mean age 66.7±11.6 years; 14 men) with symptomatic de novo SFA lesions undergoing angioplasty with the In.Pact Admiral paclitaxel-coated balloon and subsequent implantation of the Igaki-Tamai bioresorbable scaffold. All patients were claudicants. The average diameter stenosis was 89.7%, and the mean length was 43.6 mm. Clinical examinations with duplex sonography were performed after 1, 6, 9, and 12 months. The main study outcomes were technical success, restenosis, target lesion revascularization (TLR), ankle-brachial index (ABI) improvement, and changes in quality of life evaluated with the walking impairment questionnaire. Safety was assessed by monitoring the occurrence of adverse events.
  
  
  RESULTS
  Angioplasty with a paclitaxel-coated balloon was performed in all patients, resulting in an average diameter stenosis of 24%. Subsequent implantation of the Igaki-Tamai scaffold reduced the average diameter stenosis to 3.5%. In the first 6 months, 2 cases of restenosis were reported, with no TLRs within that period. However, by the 12-month follow-up in 19 patients, 11 patients had lost in-stent patency. Among these patients, 8 had TLRs, which were the only adverse events recorded that were referable to the procedure. Quality-of-life assessments showed improvement in the majority of patients.
  
  
  CONCLUSIONS
  The GAIA-DEB study shows that DEB treatment of the femoral artery prior to the implantation of the biodegradable Igaki-Tamai scaffold is safe. However, the antiproliferative actions of paclitaxel in the vessel wall were not effective in preventing restenosis. In-stent restenosis occurred predominantly after 6 months.
authors.affiliation: Vascular Clinic, Hanusch Hospital, Vienna, Austria office@drwerner.eu.
authors.forename: Martin
authors.initials: M
authors.lastname: Werner
authors.affiliation: Department for Interventional Angiology, University Hospital Leipzig, Germany.
authors.forename: Andrej
authors.initials: A
authors.lastname: Schmidt
authors.affiliation: Department for Interventional Angiology, University Hospital Leipzig, Germany.
authors.forename: Susanne
authors.initials: S
authors.lastname: Scheinert
authors.affiliation: Department for Interventional Angiology, University Hospital Leipzig, Germany.
authors.forename: Ursula
authors.initials: U
authors.lastname: Banning-Eichenseer
authors.affiliation: Department for Interventional Angiology, University Hospital Leipzig, Germany.
authors.forename: Matthias
authors.initials: M
authors.lastname: Ulrich
authors.affiliation: Department for Interventional Angiology, University Hospital Leipzig, Germany.
authors.forename: Yvonne
authors.initials: Y
authors.lastname: Bausback
authors.affiliation: Department for Interventional Angiology, University Hospital Leipzig, Germany.
authors.forename: Sabine
authors.initials: S
authors.lastname: Steiner
authors.affiliation: Department for Interventional Angiology, University Hospital Leipzig, Germany.
authors.forename: Dierk
authors.initials: D
authors.lastname: Scheinert
mesh_terms: D020341:Absorbable Implants; D000368:Aged; D000800:Angioplasty, Balloon / Q000009:adverse effects / Q000295:instrumentation*; D055109:Ankle Brachial Index; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D020099:Coated Materials, Biocompatible; D003251:Constriction, Pathologic; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging / Q000503:physiopathology; D005858:Germany; D006801:Humans; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage*; D058729:Peripheral Arterial Disease / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D010865:Pilot Projects; D011446:Prospective Studies; D012008:Recurrence; D019233:Retreatment; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D018616:Ultrasonography, Doppler, Duplex; D062666:Vascular Access Devices; D014654:Vascular Patency
chemical_list: D002317:Cardiovascular Agents; D020099:Coated Materials, Biocompatible; D017239:Paclitaxel
keywords: biodegradable scaffold; biodegradable stent; peripheral artery disease; poly-l-lactic acid scaffold; quality of life; restenosis; superficial femoral artery; target lesion revascularization