Treatment of small coronary vessels with a paclitaxel drug-eluting balloon was superior to a paclitaxel-eluting stent for angiographic late loss (difference -0.21 mm; P=0.001 for superiority).
RCT (n=182)
Yes
Does a paclitaxel drug-eluting balloon reduce angiographic late loss compared to a paclitaxel-eluting stent in patients with small coronary vessel lesions?
In small coronary vessels, a paclitaxel drug-eluting balloon was superior to a paclitaxel-eluting stent in reducing angiographic late loss, with similar clinical event rates at 6 months.
Effect estimate: difference -0.21 mm (95% CI -0.34 to -0.09)
Absolute Event Rate: 0.08% vs 0.29%
p-value: p(noninferiority) < 0.001; p(superiority) = 0.001
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 (10% vs. 14.6%; p = 0.35), corrected target lesion revascularization (4.4% vs. 7.6%; p = 0.37), and MACE (10% vs. 16.3%; p = 0.21). corrected. 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).
Latib et al. (Wed,) conducted a rct in Small coronary vessel disease (n=182). Paclitaxel drug-eluting balloon (DEB) and provisional bare-metal stenting vs. Paclitaxel-eluting stent (PES) was evaluated on Angiographic in-stent (in-balloon) late loss (difference -0.21 mm, 95% CI -0.34 to -0.09, p=p(noninferiority) < 0.001; p(superiority) = 0.001). Treatment of small coronary vessels with a paclitaxel drug-eluting balloon was superior to a paclitaxel-eluting stent for angiographic late loss (difference -0.21 mm; P=0.001 for superiority).
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