دورية أكاديمية
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
| العنوان: | 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 |
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| المؤلفون: | 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. |
| المساهمون: | 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. |
| بيانات النشر: | ELSEVIER SCIENCE INC |
| سنة النشر: | 2012 |
| المجموعة: | Università degli Studi di Messina: IRIS |
| مصطلحات موضوعية: | drug-eluting balloon, drug-eluting stent, late lo, paclitaxel, restenosi, revascularization, Aged, Antineoplastic Agents, Phytogenic, Coronary Angiography, Coronary Restenosi, Female, Human, Male, Middle Aged, Prospective Studie, Radiography, Interventional, Treatment Outcome, Tremor, Angioplasty, Balloon, Coronary |
| الوصف: | 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) © 2012 American College of Cardiology Foundation. |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| العلاقة: | info:eu-repo/semantics/altIdentifier/pmid/23158530; info:eu-repo/semantics/altIdentifier/wos/WOS:000312198000004; volume:60; issue:24; firstpage:2473; lastpage:2480; numberofpages:8; journal:JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY; http://hdl.handle.net/11570/3194766Test; info:eu-repo/semantics/altIdentifier/scopus/2-s2.0-84871342561 |
| DOI: | 10.1016/j.jacc.2012.09.020 |
| الإتاحة: | https://doi.org/10.1016/j.jacc.2012.09.020Test http://hdl.handle.net/11570/3194766Test |
| رقم الانضمام: | edsbas.6EC0062E |
| قاعدة البيانات: | BASE |
| DOI: | 10.1016/j.jacc.2012.09.020 |
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