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
N1 - Funding Information:
The BELLO study was supported by an unrestricted grant from Invatec SpA , who had no role in the design, conduct, or reporting of the study. Industry had no role in the preparation, review, or approval of this manuscript. Dr. Latib serves on a Medtronic advisory board. Dr. Cremonesi is a consultant for Medtronic and Boston Scientific. Dr. Varbella has received research grants from Medtronic , Boston Scientific , Abbott Vascular , Terumo , Sanitex , Sorin , Empass , MeDi , Kardia , St. Jude Medical , the Medicine Company , and Eli Lilly & Company . All other authors have reported that they have no relationships to disclose relevant to the contents of this paper. The first two authors contributed equally to this work and are joint first authors.
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 <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; pnoninferiority < 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 <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; pnoninferiority < 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
SN - 0735-1097
VL - 60
SP - 2473
EP - 2480
JO - Journal of the American College of Cardiology
JF - Journal of the American College of Cardiology
IS - 24
ER -