Original title: 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 Reference: Referencia: Azeem Latib et al J Am Coll Cardiol 2012;()doi:10.1016/j.jacc.2012.09.020
The utility of paclitaxel-eluting balloons to treat in-stent restenosis is known but data for novo lesions is more limited.
The aim of this study was to evaluate the efficacy of paclitaxel-eluting balloons (PEB) compared with paclitaxel-eluting stents (PES) for the reduction of restenosis in small vessels. This multicenter and prospective study randomized 182 patients with lesions in small vessels (reference diameter <2.8 mm) to receive a paclitaxel eluting balloon and provisional conventional stent (n = 90) or a paclitaxel-eluting stent.
The primary endpoint of non-inferiority was late lumen loss with a delta of 0.25 mm. Secondary end points were binary restenosis, TLR and MACE, (death, myocardial infarction and revascularization), at 6 months. Both groups were well balanced except for the smallest diameter in PEB-treated vessels, (2.15 ± 0.27 mm vs. 2.25 ± 0.24 mm, p = 0.003). 20% of the PEB group required a conventional stent rescue after dilation.
The primary end point was significantly lower with PEB compared with PES, (0.08 ± 0.38 mm vs. 0.29 ± 0.44 mm, p for noninferiority <0.001, p for superiority = 0.001). At 6 months both were similar in binary restenosis, (PEB 8.9% versus PES 14.1%, P = 0.25), TLR, (PEB 4.4% versus PES 7.6%, p = 0.37), and MACE, (PEB 7.8% versus DES 13.2%, P = 0.77).
Conclusion
Small-vessel angioplasty using PEB had a lower late lumen loss with similar restenosis and revascularization than paclitaxel-eluting stents at 6 months.
Editorial Comment:
The results are promising, especially considering that the average size of the vessels was <2.5 mm. It would be very interesting to track this in a longer-term study and with a primary clinical purpose as well as a comparison against edge limus eluting stents.
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