title: Drug-eluting stents for revascularization of infrapopliteal arteries: updated meta-analysis of randomized trials.
abstract: OBJECTIVE
  This study sought to undertake an updated meta-analysis of randomized trials investigating the outcomes of percutaneous revascularization with primary drug-eluting stenting in patients with atherosclerotic disease of infrapopliteal arteries.
  
  
  BACKGROUND
  In atherosclerotic disease of infrapopliteal arteries, drug-eluting stents (DESs) improve patency rates compared with plain balloon angioplasty or bare-metal stents (BMSs). However, the clinical impact of DES placement in this vascular territory still remains uncertain.
  
  
  METHODS
  We searched MEDLINE, Embase, CENTRAL (Cochrane Central Register of Controlled Trials), scientific session abstracts, and relevant Websites. The keywords used were "below the knee," "infrapopliteal artery," "angioplasty," "drug-eluting stent(s)," "bare metal stent(s)," "trial," and "randomized trial." Inclusion criteria were randomized design, intention-to-treat analysis, and a minimum of 6-month follow-up. Exclusion criteria were vessels treated other than infrapopliteal arteries; devices used other than DESs, plain balloons, or BMSs; and duplicated data. The primary endpoint was target lesion revascularization; secondary endpoints were restenosis, amputation, death, and improvement in Rutherford class.
  
  
  RESULTS
  A total of 611 patients from 5 trials were randomly assigned to DESs (n = 294) versus control therapy (plain balloon angioplasty/BMS implantation, n = 307). Overall, the median lesion length was 26.8 mm (interquartile range [IQR]: 18.2 to 30.0 mm) with a reference vessel diameter of 2.86 mm (IQR: 2.68 to 3.00 mm). At a median follow-up of 12 months (IQR: 12 to 36 months), DESs reduced the risk of target lesion revascularization (odds ratio [OR]: 0.31; 95% confidence interval [CI]: 0.18 to 0.54; p < 0.001), restenosis (OR: 0.25; 95% CI: 0.15 to 0.43; p < 0.001), and amputation (OR: 0.50; 95% CI: 0.26 to 0.97); p = 0.04) without a significant difference in terms of death (OR: 0.81; 95% CI: 0.45 to 1.49; p = 0.50) and Rutherford class improvement (OR: 1.36; 95% CI: 0.91 to 2.04; p = 0.13) versus control therapy.
  
  
  CONCLUSIONS
  In focal disease of infrapopliteal arteries, DES therapy reduces the risk of reintervention and amputation compared with plain balloon angioplasty or BMS implantation without any impact on mortality and Rutherford class at 1-year follow-up.
authors.affiliation: Deutsches Herzzentrum, Technische Universität, Munich, Germany.
authors.forename: Massimiliano
authors.initials: M
authors.lastname: Fusaro
authors.affiliation: Deutsches Herzzentrum, Technische Universität, Munich, Germany. Electronic address: cassese@dhm.mhn.de.
authors.forename: Salvatore
authors.initials: S
authors.lastname: Cassese
authors.affiliation: Deutsches Herzzentrum, Technische Universität, Munich, Germany.
authors.forename: Gjin
authors.initials: G
authors.lastname: Ndrepepa
authors.affiliation: Radiologische Klinik, Diagnostische und Interventionelle Radiologie, Karls-Universität, Tübingen, Germany.
authors.forename: Gunnar
authors.initials: G
authors.lastname: Tepe
authors.affiliation: Deutsches Herzzentrum, Technische Universität, Munich, Germany.
authors.forename: Lamin
authors.initials: L
authors.lastname: King
authors.affiliation: Deutsches Herzzentrum, Technische Universität, Munich, Germany.
authors.forename: Ilka
authors.initials: I
authors.lastname: Ott
authors.affiliation: Klinische Abteilung für Kardiologie, Universität Graz, Graz, Austria.
authors.forename: Mateja
authors.initials: M
authors.lastname: Nerad
authors.affiliation: Deutsches Herzzentrum, Technische Universität, Munich, Germany; DZHK-German Centre for Cardiovascular Research, partner site Munich Heart Alliance, Munich, Germany.
authors.forename: Heribert
authors.initials: H
authors.lastname: Schunkert
authors.affiliation: Deutsches Herzzentrum, Technische Universität, Munich, Germany; DZHK-German Centre for Cardiovascular Research, partner site Munich Heart Alliance, Munich, Germany.
authors.forename: Adnan
authors.initials: A
authors.lastname: Kastrati
mesh_terms: D000671:Amputation, Surgical; D000800:Angioplasty, Balloon / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D016009:Chi-Square Distribution; D003251:Constriction, Pathologic; D054855:Drug-Eluting Stents; D019317:Evidence-Based Medicine; D006801:Humans; D023821:Limb Salvage; D016017:Odds Ratio; D058729:Peripheral Arterial Disease / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D011150:Popliteal Artery; D016032:Randomized Controlled Trials as Topic; D018570:Risk Assessment; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome
keywords: ARR; BMS; CI; CLI; DAPT; DES; IQR; NNT; OR; RC; Rutherford class; TLR; absolute risk reduction; bare-metal stent(s); confidence interval; critical limb ischemia; drug-eluting stent(s); dual antiplatelet therapy; infrapopliteal artery; interquartile range; meta-analysis; number needed to treat; odds ratio; plain angioplasty; target lesion revascularization