title: A randomized multicenter study comparing a paclitaxel drug-eluting balloon with a paclitaxel-eluting stent in small coronary vessels: the BELLO (Balloon Elution and Late Loss Optimization) study.
abstract: OBJECTIVE
  The aim of this study was to evaluate the efficacy of drug-eluting balloons (DEB) compared with paclitaxel-eluting stents (PES) for the reduction of restenosis in small vessels.
  
  
  BACKGROUND
  DEB have been shown to be effective in the treatment of coronary in-stent restenosis, but data are limited regarding their efficacy in de novo disease.
  
  
  METHODS
  BELLO (Balloon Elution and Late Loss Optimization) is a prospective, multicenter trial that randomized 182 patients with lesions located in small vessels (reference diameter <2.8 mm) to treatment with paclitaxel DEB and provisional bare-metal stenting (n = 90) or PES implantation (n = 92). The primary endpoint was noninferiority of angiographic in-stent (in-balloon) late loss with a delta of 0.25 mm. Secondary endpoints were angiographic restenosis, target lesion revascularization, and major adverse cardiac events (MACE; death, myocardial infarction, target vessel revascularization) at 6 months.
  
  
  RESULTS
  Baseline characteristics were well matched, except for a smaller vessel size in the DEB group (2.15 ± 0.27 mm vs. 2.25 ± 0.24 mm; p = 0.003). The majority (89%) of lesions involved vessels with a diameter <2.5 mm. Bailout stenting was required in 20% of lesions in the DEB group. The primary endpoint of in-stent (in-balloon) late loss was significantly less with DEB compared with PES (0.08 ± 0.38 mm vs. 0.29 ± 0.44 mm; difference -0.21; 95% CI: -0.34 to -0.09; p(noninferiority) < 0.001; p(superiority) = 0.001). At 6 months, DEB and PES were associated with similar rates of angiographic restenosis (10% vs. 14.6%; p = 0.35), [corrected] target lesion revascularization (4.4% vs. 7.6%; p = 0.37), and MACE (10% vs. 16.3%; p = 0.21). [corrected].
  
  
  CONCLUSIONS
  Treatment of small-vessel disease with a paclitaxel DEB was associated with less angiographic late loss and similar rates of restenosis and revascularization as a PES. (Balloon Elution and Late Loss Optimization [BELLO]; Study NCT01086579).
authors.affiliation: Interventional Cardiology Unit, EMO-GVM Centro Cuore Columbus, and Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Azeem
authors.initials: A
authors.lastname: Latib
authors.forename: Antonio
authors.initials: A
authors.lastname: Colombo
authors.forename: Fausto
authors.initials: F
authors.lastname: Castriota
authors.forename: Antonio
authors.initials: A
authors.lastname: Micari
authors.forename: Alberto
authors.initials: A
authors.lastname: Cremonesi
authors.forename: Francesco
authors.initials: F
authors.lastname: De Felice
authors.forename: Alfredo
authors.initials: A
authors.lastname: Marchese
authors.forename: Maurizio
authors.initials: M
authors.lastname: Tespili
authors.forename: Patrizia
authors.initials: P
authors.lastname: Presbitero
authors.forename: Gregory A
authors.initials: GA
authors.lastname: Sgueglia
authors.forename: Francesca
authors.initials: F
authors.lastname: Buffoli
authors.forename: Corrado
authors.initials: C
authors.lastname: Tamburino
authors.forename: Ferdinando
authors.initials: F
authors.lastname: Varbella
authors.forename: Alberto
authors.initials: A
authors.lastname: Menozzi
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage*; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000517:prevention & control*; D054855:Drug-Eluting Stents; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage*; D011446:Prospective Studies; D015641:Radiography, Interventional; D016896:Treatment Outcome; D014202:Tremor
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D017239:Paclitaxel