title: Comparison of paclitaxel drug-eluting balloon and paclitaxel-eluting stent in small coronary vessels in diabetic and nondiabetic patients - results from the BELLO (balloon elution and late loss optimization) trial.
abstract: OBJECTIVE
  To evaluate the impact of diabetes on the efficacy of drug-eluting balloon (DEB) as compared to paclitaxel-eluting stent (PES) for the reduction of restenosis in small vessels according to the presence of diabetes in patients enrolled in the BELLO (Balloon Elution and Late Loss Optimization) trial.
  
  
  BACKGROUND
  Small vessel disease is common in diabetic patients but currently there are no available data regarding DEB in these patients.
  
  
  METHODS
  In the BELLO trial, 182 patients with lesions in small vessels were randomized 1:1 to receive DEB or PES. In the current sub analysis, patients were stratified according to the presence of diabetes. The diabetic group consisted of 74 patients (DEB=39, PES=35) and the nondiabetic group of 108 patients (DEB=51, PES=57). Angiographic endpoints examined were in-stent/in-balloon and in-segment late loss and binary restenosis at 6 months. Clinical endpoints were major adverse cardiac events (MACE; death, myocardial infarction, target vessel revascularization) at 1 year.
  
  
  RESULTS
  In-stent/in-balloon late loss was significantly less with DEB as compared to PES in both diabetic (0.05±0.41 vs. 0.30±0.51mm, p=0.033) and nondiabetic patients (0.10±0.36 vs. 0.29±0.40mm, p=0.015). In patients with diabetes, angiographic restenosis and in-segment late loss were significantly lower with DEB as compared to PES (respectively, 6.3% vs. 25.0%; p=0.039 and -0.013±0.39 vs. 0.25±0.53; p=0.023), with no differences noted in nondiabetic patients. The cumulative MACE rate at 1 year was similar between DEB and PES in both the diabetic (13.2% vs. 25%, p=0.194) and nondiabetic groups (11.8% vs. 14.3%, p=0.699).
  
  
  CONCLUSIONS
  Diabetes does not appear to have a negative impact on the efficacy of DEB in small vessels, which were associated with better angiographic outcomes at 6 months in this complex subgroup. Larger studies are needed to confirm these findings.
authors.affiliation: Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy; Interventional Cardiology Unit, EMO-GVM Centro Cuore Columbus, Milan, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Giannini
authors.affiliation: Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy; Interventional Cardiology Unit, EMO-GVM Centro Cuore Columbus, Milan, Italy. Electronic address: alatib@gmail.com.
authors.forename: Azeem
authors.initials: A
authors.lastname: Latib
authors.affiliation: Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Richard J
authors.initials: RJ
authors.lastname: Jabbour
authors.affiliation: Interventional Cardiology Unit, EMO-GVM Centro Cuore Columbus, Milan, Italy.
authors.forename: Charis
authors.initials: C
authors.lastname: Costopoulos
authors.affiliation: Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Alaide
authors.initials: A
authors.lastname: Chieffo
authors.affiliation: Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Mauro
authors.initials: M
authors.lastname: Carlino
authors.affiliation: Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Matteo
authors.initials: M
authors.lastname: Montorfano
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, Ospedale Santa Maria Goretti, Latina, Italy.
authors.forename: Gregory A
authors.initials: GA
authors.lastname: Sgueglia
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, San Raffaele Scientific Institute, Milan, Italy; Interventional Cardiology Unit, EMO-GVM Centro Cuore Columbus, Milan, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Colombo
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D062906:Cardiac Catheters; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D020099:Coated Materials, Biocompatible; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000209:etiology; D023921:Coronary Stenosis / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D003925:Diabetic Angiopathies / Q000000981:diagnostic imaging / Q000401:mortality / Q000628:therapy*; D054855:Drug-Eluting Stents; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology; D017239:Paclitaxel / Q000008:administration & dosage*; D011446:Prospective Studies; D011474:Prosthesis Design; D016037:Single-Blind Method; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents; D020099:Coated Materials, Biocompatible; D017239:Paclitaxel
keywords: Diabetes mellitus; Drug-eluting balloon; Paclitaxel-eluting stent; Small coronary vessel disease