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

Azeem Latib, Antonio Colombo, Fausto Castriota, Antonio Micari, Alberto Cremonesi, Francesco De Felice, Alfredo Marchese, Maurizio Tespili, Patrizia Presbitero, Gregory A. Sgueglia, Francesca Buffoli, Corrado Tamburino, Ferdinando Varbella, Alberto Menozzi

Research output: Contribution to journalArticle

Abstract

Objectives: 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 noninferiority <0.001; psuperiority = 0.001). At 6 months, DEB and PES were associated with similar rates of angiographic restenosis (8.9% vs. 14.1%; p = 0.25), target lesion revascularization (4.4% vs. 7.6%; p = 0.37), and MACE (7.8% vs. 13.2%; p = 0.77). 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)

Original languageEnglish
Pages (from-to)2473-2480
Number of pages8
JournalJournal of the American College of Cardiology
Volume60
Issue number24
DOIs
Publication statusPublished - Dec 18 2012

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Keywords

  • drug-eluting balloon
  • drug-eluting stent
  • late loss
  • paclitaxel
  • restenosis
  • revascularization

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Latib, A., Colombo, A., Castriota, F., Micari, A., Cremonesi, A., De Felice, F., Marchese, A., Tespili, M., Presbitero, P., Sgueglia, G. A., Buffoli, F., Tamburino, C., Varbella, F., & Menozzi, A. (2012). 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. Journal of the American College of Cardiology, 60(24), 2473-2480. https://doi.org/10.1016/j.jacc.2012.09.020