- 作者：Azeem Latib ; MD? ; Antonio Colombo ; MD? ; info@emocolumbus.it ; Fausto Castriota ; MD&dagger ; ; Antonio Micari ; MD&Dagger ; ; Alberto Cremonesi ; MD§ ; ; Francesco De Felice ; MD¡Î ; Alfredo Marchese ; MD¶ ; ; Maurizio Tespili ; MD# ; Patrizia Presbitero ; MD?? ; Gregory A. Sgueglia ; MD&dagger ; &dagger ; ; Francesca Buffoli ; MD&Dagger ; &Dagger ; ; Corrado Tamburino ; MD§ ; § ; ; Ferdinando Varbella ; MD¡Î¡Î ; Alberto Menozzi ; MD¶ ; ¶ ;
- 关键词：drug-eluting balloon ; drug-eluting stent ; late loss ; paclitaxel ; restenosis ; revascularization
- 刊名：Journal of the American College of Cardiology
- 出版年：2012
- 出版时间：18 December, 2012
- 年：2012
- 卷：60
- 期：24
- 页码：2473-2480
- 全文大小：665 K
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 ¡À 0.27 mm vs. 2.25 ¡À 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 ¡À 0.38 mm vs. 0.29 ¡À 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 )