title: Paclitaxel-coated versus uncoated balloon angioplasty reduces target lesion revascularization in patients with femoropopliteal arterial disease: a meta-analysis of randomized trials.
abstract: BACKGROUND
  In disease of the femoropopliteal artery, paclitaxel-coated balloon (PCB) therapy improved angiographic outcomes as compared with uncoated balloon (UCB) angioplasty. Nevertheless, it remains uncertain whether PCB may reduce the need for reintervention.
  
  
  RESULTS
  We searched Medline, EMBASE, the Cochrane Central Register of Controlled Trials (CENTRAL), scientific session abstracts, and relevant web sites for trials of PCB versus UCB angioplasty. Key words were: "superficial femoral artery," "popliteal artery," "angioplasty," "drug-eluting balloon," "paclitaxel-eluting balloon," and "randomized trial." Inclusion criteria were: (1) randomized design; (2) intention-to-treat analysis; and (3) ≥6-month follow-up. Exclusion criteria were: (1) vessel treated other than femoropopliteal artery; (2) device used other than PCB/UCB; and (3) irretrievable or duplicated data. No restrictions (language, publication date, or status) were applied. The primary end point was target lesion revascularization. Secondary end points were: angiographic binary restenosis and late lumen loss and all-cause mortality. A total of 381 patients enrolled in 4 randomized trials were included (PCB, n=186 versus UCB, n=195). Median follow-up was 10.3 months. Angioplasty with PCB versus UCB reduces target lesion revascularization (12.2% versus 27.7%; OR, 0.22; 95% CI, 0.13-0.38; P<0.00001), angiographic restenosis (18.7% versus 45.5%; OR, 0.26; 95% CI, 0.14-0.48; P<0.0001), and late lumen loss (range, -0.05 to 0.50 mm versus 0.61-1.7 mm; weighted mean difference, -0.75 mm; 95% CI, -1.06 to -0.45; P<0.00001). No mortality difference was observed for PCB versus UCB (2.1% versus 3.2%; OR, 0.99; 95% CI, 0.39-2.49; P=0.98).
  
  
  CONCLUSIONS
  In femoropopliteal arterial disease, PCB therapy is associated with superior antirestenotic efficacy as compared with UCB angioplasty with no evidence of a differential safety profile.
authors.affiliation: Deutsches Herzzentrum, Technische Universität, Lazarettstrasse 36, Munich, Germany.
authors.forename: Salvatore
authors.initials: S
authors.lastname: Cassese
authors.forename: Robert A
authors.initials: RA
authors.lastname: Byrne
authors.forename: Ilka
authors.initials: I
authors.lastname: Ott
authors.forename: Gjin
authors.initials: G
authors.lastname: Ndrepepa
authors.forename: Mateja
authors.initials: M
authors.lastname: Nerad
authors.forename: Adnan
authors.initials: A
authors.lastname: Kastrati
authors.forename: Massimiliano
authors.initials: M
authors.lastname: Fusaro
mesh_terms: D000800:Angioplasty, Balloon / Q000009:adverse effects / Q000379:methods*; D020099:Coated Materials, Biocompatible / Q000627:therapeutic use; D054855:Drug-Eluting Stents / Q000009:adverse effects; D005263:Femoral Artery / Q000502:physiology; D006801:Humans; D017239:Paclitaxel / Q000627:therapeutic use*; D016491:Peripheral Vascular Diseases / Q000503:physiopathology / Q000628:therapy*; D011150:Popliteal Artery / Q000502:physiology; D016032:Randomized Controlled Trials as Topic; D055502:Secondary Prevention; D050257:Tubulin Modulators / Q000627:therapeutic use
chemical_list: D020099:Coated Materials, Biocompatible; D050257:Tubulin Modulators; D017239:Paclitaxel