title: The Mid-Term Clinical Follow-Up Using Drug-Eluting Balloons on Tibial Artery "De Novo" Lesions in Patients With Critical Limb Ischemia: A Cohort Study.
abstract: BACKGROUND
  Restenosis due to intimal hyperplasia (IH) is a major clinical issue that affects the success of lower limb endovascular surgery. After 1 year, restenosis occurs in 40% to 60% of the treated vessels. The possibility to reduce IH using local antiproliferative drugs, such as taxols, has been the rationale for the clinical applications of drug-eluting stents and drug-eluting balloons (DEBs). The purpose of this study was to evaluate the clinical and instrumental efficacy of DEBs versus simple percutaneous transluminal angioplasty (PTA) in patients affected by chronic limb ischemia (CLI) with tibial artery "de novo" lesions.
  
  
  METHODS
  A retrospective analysis was performed and included all consecutive patients who underwent endovascular treatment for CLI in our centers between January 2011 and March 2013. Inclusion criteria were (1) "de novo" tibial artery stenosis and (2) Rutherford class >4. Lesions were further divided by TransAtlantic Inter-Societal Consensus (TASC) classification into groups A, B, C, and D.
  
  
  RESULTS
  Between January 2010 and March 2013, a total of 138 patients underwent simple PTA or DEB for CLI, and the groups were clinically and demographically homogenous. We decided to use DEBs in 70 cases. An improvement in the Rutherford Scale in cumulative and single TASC lesions classification was better in the DEB group (74% vs 51%; P = .024) at 24 months than in the PTA group. In the DEB group, the increase in ankle-brachial index was significantly higher than in the PTA group (P = .039).
  
  
  CONCLUSIONS
  Our experience in addition to the existing literature supports the use of DEB in patients with CLI Rutherford class >3.
authors.affiliation: Department of Surgery, IRCCS Istituto Auxologico Italiano, Milan, Italy valerio.tolva@policlinicodimonza.it.
authors.forename: Valerio
authors.initials: V
authors.lastname: Tolva
authors.affiliation: Department of Surgery, IRCCS Istituto Auxologico Italiano, Milan, Italy.
authors.forename: Renato
authors.initials: R
authors.lastname: Casana
authors.affiliation: Nuffield Department of Surgical Sciences, John Radcliff Hospital, University of Oxford, Oxford, United Kingdom Department of Vascular Surgery, University Medical Center, Utrecht, the Netherlands.
authors.forename: Anne
authors.initials: A
authors.lastname: Huibers
authors.affiliation: Department of Cardiovascular, Neural and Metabolic Sciences, S.Luca Hospital, IRCCS Istituto Auxologico Italiano, Milan, Italy Department of Health Sciences, University of Milano-Bicocca, Milan, Italy.
authors.forename: Gianfranco
authors.initials: G
authors.lastname: Parati
authors.affiliation: Department of Vascular Surgery, Policlinico Di Monza Hospital, Monza, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Bianchi
authors.affiliation: Department of Vascular Surgery, Policlinico Di Monza Hospital, Monza, Italy.
authors.forename: Lea
authors.initials: L
authors.lastname: Cireni
authors.affiliation: Vascular and Endovascular Surgery Unit, Mauriziano Umberto Hospital, Turin, Italy.
authors.forename: Emanuele
authors.initials: E
authors.lastname: Ferrero
authors.affiliation: Nuffield Department of Surgical Sciences, John Radcliff Hospital, University of Oxford, Oxford, United Kingdom.
authors.forename: Allison
authors.initials: A
authors.lastname: Halliday
mesh_terms: D000368:Aged; D000671:Amputation, Surgical; D000800:Angioplasty, Balloon / Q000009:adverse effects / Q000295:instrumentation*; D055109:Ankle Brachial Index; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D020099:Coated Materials, Biocompatible; D004867:Equipment Design; D005060:Europe; D005260:Female; D006801:Humans; D006965:Hyperplasia; D007511:Ischemia / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000628:therapy*; D023821:Limb Salvage; D035002:Lower Extremity / Q000098:blood supply*; D008297:Male; D008875:Middle Aged; D058426:Neointima; D058729:Peripheral Arterial Disease / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000628:therapy*; D012008:Recurrence; D012189:Retrospective Studies; D016909:Tibial Arteries / Q000000981:diagnostic imaging / Q000503:physiopathology; D013997:Time Factors; D016896:Treatment Outcome; D062666:Vascular Access Devices
chemical_list: D002317:Cardiovascular Agents; D020099:Coated Materials, Biocompatible
keywords: drug-eluting balloon; intimal hyperplasia; restenosis