title: Drug-Coated Balloons for Complex Femoropopliteal Lesions: 2-Year Results of a Real-World Registry.
abstract: OBJECTIVE
  The authors sought to investigate the efficacy of a drug-coated balloon (DCB) for treatment of complex femoropopliteal lesions.
  
  
  BACKGROUND
  Superiority of DCBs compared with uncoated balloon angioplasty for femoropopliteal interventions has been demonstrated in randomized trials for short lesions. Their performance in complex lesions with higher restenosis rates is unclear.
  
  
  METHODS
  Patency, target lesion revascularization (TLR) rate, clinical improvement, and safety endpoints of femoropopliteal lesions in 288 limbs (n = 260) treated with the In.Pact Pacific or Admiral DCB (Medtronic, Minneapolis, Minnesota) were retrospectively analyzed for up to 2 years of follow-up. Predictors of restenosis were identified by logistic regression.
  
  
  RESULTS
  Lesions were de novo in 51.7%, restenosis in 11.1%, and in-stent restenosis in 37.2%. Mean lesion length was 24.0 ± 10.2 cm, and 65.3% were occluded. Stent implantation was performed in 23.3%. Kaplan Meier estimates of primary patency were 79.2% and 53.7% for all lesions at 1 and 2 years, respectively, whereas freedom from TLR was 85.4% and 68.6%. Primary patency for in-stent restenosis treatment was 76.6% and 48.6%, and freedom from TLR was 83.0% and 58.7% at 1 and 2 years, respectively. Rutherford category improved from a median 3.3 to 1.2 at 1 year, and to 1.1 at 2 years. Major amputation rate was 2.1% at 2 years. No adverse events were thought to be attributable to the coating of the balloon.
  
  
  CONCLUSIONS
  These results suggest that DCB are safe and effective in delaying rather than preventing restenosis in long, complex lesions and restenosis of the femoropopliteal tract. Further studies are recommended to confirm these results.
authors.affiliation: Department of Interventional Angiology, University Hospital Leipzig and Center of Vascular Medicine, Angiology and Vascular Surgery Park Hospital Leipzig, Germany. Electronic address: dr.andrej.schmidt@gmail.com.
authors.forename: Andrej
authors.initials: A
authors.lastname: Schmidt
authors.affiliation: Cardioangiological Center Bethanien, Frankfurt, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Piorkowski
authors.affiliation: Department of Interventional Angiology, University Hospital Leipzig and Center of Vascular Medicine, Angiology and Vascular Surgery Park Hospital Leipzig, Germany.
authors.forename: Henrik
authors.initials: H
authors.lastname: Görner
authors.affiliation: Department of Interventional Angiology, University Hospital Leipzig and Center of Vascular Medicine, Angiology and Vascular Surgery Park Hospital Leipzig, Germany.
authors.forename: Sabine
authors.initials: S
authors.lastname: Steiner
authors.affiliation: Department of Interventional Angiology, University Hospital Leipzig and Center of Vascular Medicine, Angiology and Vascular Surgery Park Hospital Leipzig, Germany.
authors.forename: Yvonne
authors.initials: Y
authors.lastname: Bausback
authors.affiliation: Department of Interventional Angiology, University Hospital Leipzig and Center of Vascular Medicine, Angiology and Vascular Surgery Park Hospital Leipzig, Germany.
authors.forename: Susanne
authors.initials: S
authors.lastname: Scheinert
authors.affiliation: Department of Interventional Angiology, University Hospital Leipzig and Center of Vascular Medicine, Angiology and Vascular Surgery Park Hospital Leipzig, Germany.
authors.forename: Ursula
authors.initials: U
authors.lastname: Banning-Eichenseer
authors.affiliation: Department of Vascular Surgery, University Hospital Leipzig, Germany.
authors.forename: Holger
authors.initials: H
authors.lastname: Staab
authors.affiliation: Department of Vascular Surgery, University Hospital Leipzig, Germany.
authors.forename: Daniela
authors.initials: D
authors.lastname: Branzan
authors.affiliation: Department of Surgery, Prince of Wales Hospital and University of New South Wales, Sydney, Australia.
authors.forename: Ramon L
authors.initials: RL
authors.lastname: Varcoe
authors.affiliation: Department of Interventional Angiology, University Hospital Leipzig and Center of Vascular Medicine, Angiology and Vascular Surgery Park Hospital Leipzig, Germany.
authors.forename: Dierk
authors.initials: D
authors.lastname: Scheinert
mesh_terms: D000368:Aged; D000800:Angioplasty, Balloon / Q000009:adverse effects / Q000295:instrumentation*; D002317:Cardiovascular Agents / Q000008:administration & dosage* / Q000009:adverse effects; D016009:Chi-Square Distribution; D020099:Coated Materials, Biocompatible; D004867:Equipment Design; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging / Q000187:drug effects* / Q000503:physiopathology; D006801:Humans; D053208:Kaplan-Meier Estimate; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D016017:Odds Ratio; D058729:Peripheral Arterial Disease / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000628:therapy*; D011150:Popliteal Artery / Q000000981:diagnostic imaging / Q000187:drug effects* / Q000503:physiopathology; D012008:Recurrence; D012042:Registries; D012189:Retrospective Studies; D012307:Risk Factors; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome; D062666:Vascular Access Devices; D014654:Vascular Patency
chemical_list: D002317:Cardiovascular Agents; D020099:Coated Materials, Biocompatible
keywords: drug-coated balloon; femoral artery; long lesion; popliteal artery; restenosis