title: A 2-year follow-up of a randomized multicenter study comparing a paclitaxel drug-eluting balloon with a paclitaxel-eluting stent in small coronary vessels the BELLO study.
abstract: OBJECTIVE
  A prospective, multi-center, randomized trial, BELLO (Balloon Elution and Late Loss Optimization), showed that the primary endpoint of in-stent (in-balloon) late loss was significantly less with drug-eluting balloons (DEB) as compared with paclitaxel-eluting stents (PES). At 6 months, DEB and PES were associated with similar rates of angiographic restenosis, target lesion revascularization (TLR), and major adverse cardiac events (MACE) defined as death, myocardial infarction and target vessel revascularization. The aim of this study was to report 2-year clinical outcomes after treatment of de novo small vessel disease with DEB as compared with PES.
  
  
  METHODS
  A total of 182 patients were enrolled and randomized to treatment with DEB (n=90) in 94 lesions or PES (n=92) in 98 lesions. The study endpoint was the incidence of MACE at 2-year follow-up.
  
  
  RESULTS
  Two-year follow-up was achieved in almost all cases (97.8% in DEB group vs. 98.9% in PES group). There was a trend towards a lower incidence of MACE in the DEB group as compared with the PES group (14.8% vs. 25.3%; p=0.08). TLR rates in the DEB group were acceptable at 6 months, 1 year and 2 years and did not differ significantly from the PES group (4.4% vs. 7.6%, p=0.37; 6.7% vs. 12.1%, p=0.23; 6.8% vs. 12.1%, p=0.25, respectively).
  
  
  CONCLUSIONS
  Our results suggest that treatment of small vessel disease with a paclitaxel DEB is associated with a trend for improved clinical outcomes as compared with PES up to 2 years. Late catch-up phenomenon requiring repeat intervention after treatment with DEB was not evident in this study.
authors.affiliation: Interventional Cardiology Unit, EMO-GVM Centro Cuore Columbus, Milan, Italy; Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Toru
authors.initials: T
authors.lastname: Naganuma
authors.affiliation: Interventional Cardiology Unit, EMO-GVM Centro Cuore Columbus, Milan, Italy; Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Azeem
authors.initials: A
authors.lastname: Latib
authors.affiliation: Interventional Cardiology Unit, Ospedale Santa Maria Goretti, Latina, Italy.
authors.forename: Gregory A
authors.initials: GA
authors.lastname: Sgueglia
authors.affiliation: Interventional Cardiology Unit, Cardiology Department, Ospedale di Parma, Parma, Italy.
authors.forename: Alberto
authors.initials: A
authors.lastname: Menozzi
authors.affiliation: Interventional Cardiology Unit, Città di Lecce Hospital, GVM Care and Research, Lecce, Italy.
authors.forename: Fausto
authors.initials: F
authors.lastname: Castriota
authors.affiliation: Interventional Cardiology Unit, Maria Eleonora Hospital, GVM Care and Research, Palermo, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Micari
authors.affiliation: Interventional Cardiology Unit, Maria Cecilia Hospital, GVM Care and Research, Cotignola, Italy.
authors.forename: Alberto
authors.initials: A
authors.lastname: Cremonesi
authors.affiliation: Interventional Cardiology Unit, Ospedale San Camillo, Rome, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: De Felice
authors.affiliation: Interventional Cardiology Unit, Anthea Hospital, GVM Care and Research, Bari, Italy.
authors.forename: Alfredo
authors.initials: A
authors.lastname: Marchese
authors.affiliation: Interventional Cardiology Unit, Ospedale Bolognini, Seriate, Bergamo, Italy.
authors.forename: Maurizio
authors.initials: M
authors.lastname: Tespili
authors.affiliation: Interventional Cardiology Unit, Istituto Clinico Humanitas, Rozzano, Milan, Italy.
authors.forename: Patrizia
authors.initials: P
authors.lastname: Presbitero
authors.affiliation: Interventional Cardiology Unit, EMO-GVM Centro Cuore Columbus, Milan, Italy; Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Vasileios F
authors.initials: VF
authors.lastname: Panoulas
authors.affiliation: Interventional Cardiology Unit, Ospedale di Mantova, Mantova, Italy.
authors.forename: Francesca
authors.initials: F
authors.lastname: Buffoli
authors.affiliation: Interventional Cardiology Unit, Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy.
authors.forename: Corrado
authors.initials: C
authors.lastname: Tamburino
authors.affiliation: Interventional Cardiology Unit, Ospedale di Rivoli, Torino, Italy.
authors.forename: Ferdinando
authors.initials: F
authors.lastname: Varbella
authors.affiliation: Interventional Cardiology Unit, EMO-GVM Centro Cuore Columbus, Milan, Italy; Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy. Electronic address: info@emocolumbus.it.
authors.forename: Antonio
authors.initials: A
authors.lastname: Colombo
mesh_terms: D000368:Aged; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000628:therapy*; D003331:Coronary Vessels / Q000000981:diagnostic imaging / Q000187:drug effects*; D054855:Drug-Eluting Stents; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007558:Italy / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage*; D011446:Prospective Studies; D011859:Radiography; D016037:Single-Blind Method; D016896:Treatment Outcome
chemical_list: D017239:Paclitaxel
keywords: Drug-eluting balloon; Paclitaxel-eluting stents; Randomized controlled trial; Small vessel disease