title: Drug-Coated Balloons for Revascularization of Infrapopliteal Arteries: A Meta-Analysis of Randomized Trials.
abstract: The aim of this study was to perform a meta-analysis of randomized trials investigating the outcomes of patients undergoing percutaneous revascularization with drug-coated balloons (DCBs) for atherosclerotic disease of the infrapopliteal arteries.
  
  
  
  The role of DCBs as revascularization therapy for infrapopliteal arteries represents a matter of ongoing controversy.
  
  
  
  Scientific databases were searched for randomized trials of DCB therapy for atherosclerotic disease of the infrapopliteal arteries. The primary efficacy and safety outcomes were target lesion revascularization and amputation, respectively. Secondary outcomes were death, major adverse events, Rutherford class 5 or 6, and late lumen loss.
  
  
  
  A total of 641 patients enrolled in 5 trials received DCBs (n = 378) or control therapy (uncoated balloons or drug-eluting stents; n = 263). Median follow-up duration was 12 months. Patients treated with DCBs had risk for target lesion revascularization (risk ratio: 0.71; 95% confidence interval [CI]: 0.47 to 1.09; p = 0.12), amputation (risk ratio: 1.01; 95% CI: 0.65 to 1.58; p = 0.95), death (risk ratio: 1.14; 95% CI: 0.71 to 1.82; p = 0.59), major adverse events (risk ratio: 0.92; 95% CI: 0.59 to 1.43; p = 0.70), and Rutherford class 5 or 6 (risk ratio: 0.87; 95% CI: 0.46 to 1.62; p = 0.65) comparable with that of patients treated with control therapy. Lesions treated with DCBs showed lower late lumen loss (weighted mean difference -0.41; 95% CI: -0.79 to -0.03; p = 0.04) compared with those treated with control therapy.
  
  
  
  In comparison with uncoated balloons or drug-eluting stents, the treatment of infrapopliteal arteries with DCBs is associated with similar clinical outcomes and favorable angiographic efficacy at 1-year follow-up. Further studies in larger numbers of patients are still needed to definitively address the role of DCB technology in this setting. (Drug-coated balloon for revascularization of tibialpedal arteries: a meta-analysis of randomized trials; CRD42015029283).
authors.affiliation: Deutsches Herzzentrum München, Technische Universität München, Munich, Germany. Electronic address: cassese@dhm.mhn.de.
authors.forename: Salvatore
authors.initials: S
authors.lastname: Cassese
authors.affiliation: Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.
authors.forename: Gjin
authors.initials: G
authors.lastname: Ndrepepa
authors.affiliation: Cardiovascular and Neurologic Department, San Donato Hospital, Arezzo, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Liistro
authors.affiliation: Unit of Vascular and Interventional Radiology, Department of Radiological Sciences, Sapienza University, Rome, Italy.
authors.forename: Fabrizio
authors.initials: F
authors.lastname: Fanelli
authors.affiliation: Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.
authors.forename: Sebastian
authors.initials: S
authors.lastname: Kufner
authors.affiliation: Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.
authors.forename: Ilka
authors.initials: I
authors.lastname: Ott
authors.affiliation: 1. Medizinische Klinik und Poliklinik, Klinikum Rechts der Isar, Technische Universität München, Munich, Germany; Deutsches Zentrum für Herz-Kreislauf Forschung, partner site Munich Heart Alliance, Munich, Germany.
authors.forename: Karl-Ludwig
authors.initials: KL
authors.lastname: Laugwitz
authors.affiliation: Deutsches Herzzentrum München, Technische Universität München, Munich, Germany; Deutsches Zentrum für Herz-Kreislauf Forschung, partner site Munich Heart Alliance, Munich, Germany.
authors.forename: Heribert
authors.initials: H
authors.lastname: Schunkert
authors.affiliation: Deutsches Herzzentrum München, Technische Universität München, Munich, Germany; Deutsches Zentrum für Herz-Kreislauf Forschung, partner site Munich Heart Alliance, Munich, Germany.
authors.forename: Adnan
authors.initials: A
authors.lastname: Kastrati
authors.affiliation: Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.
authors.forename: Massimiliano
authors.initials: M
authors.lastname: Fusaro
mesh_terms: D000368:Aged; D000671:Amputation, Surgical; 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; D054855:Drug-Eluting Stents; D019317:Evidence-Based Medicine; D005260:Female; D006801:Humans; D023821:Limb Salvage; D008297:Male; D016017:Odds Ratio; D058729:Peripheral Arterial Disease / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D011150:Popliteal Artery / Q000503:physiopathology; D011474:Prosthesis Design; D016032:Randomized Controlled Trials as Topic; D012307:Risk Factors; 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; drug-eluting stent(s); infrapopliteal artery; meta-analysis; plain angioplasty