TY - JOUR
T1 - A randomized multicenter study comparing a paclitaxel drug-eluting balloon with a paclitaxel-eluting stent in small coronary vessels
T2 - The bello (balloon elution and late loss optimization) study
AU - Latib, Azeem
AU - Colombo, Antonio
AU - Castriota, Fausto
AU - Micari, Antonio
AU - Cremonesi, Alberto
AU - De Felice, Francesco
AU - Marchese, Alfredo
AU - Tespili, Maurizio
AU - Presbitero, Patrizia
AU - Sgueglia, Gregory A.
AU - Buffoli, Francesca
AU - Tamburino, Corrado
AU - Varbella, Ferdinando
AU - Menozzi, Alberto
PY - 2012/12/18
Y1 - 2012/12/18
N2 - 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)
AB - 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)
KW - drug-eluting balloon
KW - drug-eluting stent
KW - late loss
KW - paclitaxel
KW - restenosis
KW - revascularization
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U2 - 10.1016/j.jacc.2012.09.020
DO - 10.1016/j.jacc.2012.09.020
M3 - Article
C2 - 23158530
AN - SCOPUS:84871342561
VL - 60
SP - 2473
EP - 2480
JO - Journal of the American College of Cardiology
JF - Journal of the American College of Cardiology
SN - 0735-1097
IS - 24
ER -