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

卷:60

Article

Latib, Azeem¹  Colombo, Antonio¹  Castriota, Fausto²  Micari, Antonio³  Cremonesi, Alberto⁴  De Felice, Francesco⁵  Marchese, Alfredo⁶  Tespili, Maurizio⁷  Presbitero, Patrizia⁸  Sgueglia, Gregory A.⁹  Buffoli, Francesca¹⁰  Tamburino, Corrado¹¹  Varbella, Ferdinando¹²  Menozzi, Alberto¹³ 

[1] Ist Sci San Raffaele, Intervent Cardiol Unit, EMO GVM Ctr Cuore Columbus, I-20145 Milan, Italy

[2] Citta di Lecce Hosp, GVM Care & Res, Intervent Cardiol Unit, Lecce, Italy

[3] Maria Eleonora Hosp, GVM Care & Res, Intervent Cardiol Unit, Palermo, Italy

[4] Maria Cecilia Hosp, GVM Care & Res, Intervent Cardiol Unit, Cotignola, Italy

[5] Osped San Camillo, Intervent Cardiol Unit, Rome, Italy

[6] Anthea Hosp, GVM Care & Res, Intervent Cardiol Unit, Bari, Italy

[7] Osped Bolognini, Intervent Cardiol Unit, Bergamo, Italy

[8] Ist Clin Humanitas, Intervent Cardiol Unit, Milan, Italy

[9] Osped Santa Maria Goretti, Intervent Cardiol Unit, Latina, Italy

[10] Osped Mantova, Intervent Cardiol Unit, Mantua, Italy

[11] Univ Catania, Div Cardiol, Ferrarotto Hosp, Intervent Cardiol Unit, Catania, Italy

[12] Osped Rivoli, Intervent Cardiol Unit, Turin, Italy

[13] Osped Parma, Dept Cardiol, Intervent Cardiol Unit, Parma, Italy

关键词: drug-eluting balloon;    drug-eluting stent;    late loss;    paclitaxel;    restenosis;    revascularization;   

DOI  :  10.1016/j.jacc.2012.09.020

来源: Elsevier

【 摘 要 】

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; p(noninferiority) < 0.001; p(superiority) = 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) (J Am Coll Cardiol 2012; 60: 2473-80) (C) 2012 by the American College of Cardiology Foundation

【 授权许可】

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