title: Drug-eluting balloons for femoropopliteal lesions show better performance in de novo stenosis or occlusion than in restenosis.
abstract: OBJECTIVE
  Although drug-eluting balloons (DEBs) have shown promising results treating de novo (DN) atherosclerotic lesions and appear to have been widely adopted in Europe, their long-term efficacy in the broad spectrum of femoropopliteal restenosis (RE) remains to be proven. The purpose of the study was to assess the efficacy of paclitaxel-DEBs in restenotic (stented and nonstented) vs DN stenotic femoropopliteal arteries.
  
  
  METHODS
  The study prospectively enrolled 100 patients undergoing femoropopliteal endovascular intervention by DEB for RE or DN stenosis. Patients who received additive atherectomy were excluded. The primary end point was the primary patency (PP) rate at 12 months. Secondary end points were sustained clinical improvement and clinically driven target lesion revascularization.
  
  
  RESULTS
  DEBs were used to treat 105 limbs for intermittent claudication (82 [78%]) or critical limb ischemia (23 [22%]) in 100 patients. Of these, 111 lesions were DN stenosis (46 [41%]) or RE (65 [59%]). The overall PP was 86% at 6 months and 74% at 12 months. PP of DN stenosis was higher at 6 months (93% vs 81%) and was significantly (P = .021) better than RE at 12 months (85% vs 68%). Sustained clinical improvement based on Rutherford classification was significant in both groups (P < .001). Target lesion revascularization was significantly lower in DN stenosis compared with RE at 12 months (15% vs 32%; P = .021).
  
  
  CONCLUSIONS
  DEB angioplasty is an effective therapy for DN femoropopliteal lesions. The results of DEB angioplasty for RE are inferior compared with DN stenosis after 12 months. Nevertheless, results of DEB angioplasty for RE seem comparable with technically more demanding literature-derived strategies.
authors.affiliation: Department of Vascular and Endovascular Surgery, University of Münster, Münster, Germany. Electronic address: monika.herten@ukmuenster.de.
authors.forename: Monika
authors.initials: M
authors.lastname: Herten
authors.affiliation: Department of Vascular and Endovascular Surgery, University of Münster, Münster, Germany; Department of Vascular Surgery, St. Franziskus-Hospital Münster, Münster, Germany.
authors.forename: Giovanni B
authors.initials: GB
authors.lastname: Torsello
authors.affiliation: Department of Vascular and Endovascular Surgery, University of Münster, Münster, Germany; Department of Vascular Surgery, St. Franziskus-Hospital Münster, Münster, Germany.
authors.forename: Eva
authors.initials: E
authors.lastname: Schönefeld
authors.affiliation: Department of Vascular and Endovascular Surgery, University of Münster, Münster, Germany.
authors.forename: Britta
authors.initials: B
authors.lastname: Imm
authors.affiliation: Department of Vascular and Endovascular Surgery, University of Münster, Münster, Germany.
authors.forename: Nani
authors.initials: N
authors.lastname: Osada
authors.affiliation: Department of Vascular and Endovascular Surgery, University of Münster, Münster, Germany.
authors.forename: Stefan
authors.initials: S
authors.lastname: Stahlhoff
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000800:Angioplasty, Balloon / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D020099:Coated Materials, Biocompatible; D003251:Constriction, Pathologic; D016638:Critical Illness; D004867:Equipment Design; D005260:Female; D005263:Femoral Artery / Q000503:physiopathology; D006801:Humans; D007383:Intermittent Claudication / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D007511:Ischemia / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage*; D058729:Peripheral Arterial Disease / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D011150:Popliteal Artery / Q000503:physiopathology; D011446:Prospective Studies; D012008:Recurrence; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome; D062666:Vascular Access Devices; D014654:Vascular Patency
chemical_list: D002317:Cardiovascular Agents; D020099:Coated Materials, Biocompatible; D017239:Paclitaxel