April 25, 2026Journal of the American College of Cardiology
A Randomized Multicenter Study Comparing a Paclitaxel Drug-Eluting Balloon With a Paclitaxel-Eluting Stent in Small Coronary Vessels
Key result
Paclitaxel DEB reduces angiographic late loss by ~0.21 mm vs. PES in small coronary vessels.
- MD -0.21
- 95% CI -0.34 to -0.09
- P<0.001 for noninferiority; 0.001 for superiority
- n=182
Why the study?
Data are limited regarding the efficacy of drug-eluting balloons compared with paclitaxel-eluting stents in de novo small vessel coronary disease.
Does a paclitaxel drug-eluting balloon reduce angiographic late loss compared to a paclitaxel-eluting stent in patients with small coronary vessel lesions?
Population
182 patients with lesions in small coronary vessels (<2.8 mm)
Comparison
Paclitaxel drug-eluting balloon with provisional bare-metal stenting vs paclitaxel-eluting stent implantation
Design
Prospective multicenter randomized trial
Follow-up
6 months
Authors
Discussion
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Member takes
Implication
Supports DEB over PES in small vessel PCI; challenges routine stenting to improve angiographic outcomes.
Key Points
- To evaluate the efficacy of paclitaxel drug-eluting balloons compared with paclitaxel-eluting stents in reducing restenosis within small coronary vessels.
- Prospective, multicenter randomized noninferiority trial (BELLO; NCT01086579) enrolling 182 patients with lesions in small coronary vessels (reference diameter <2.8 mm).
- Randomly allocated patients to receive either a paclitaxel drug-eluting balloon with provisional bare-metal stenting (n = 90) or a paclitaxel-eluting stent (n = 92).
- Assessed the primary endpoint of angiographic in-stent or in-balloon late loss with a noninferiority margin delta of 0.25 mm, alongside secondary 6-month angiographic and clinical outcomes.
- In-stent or in-balloon late loss was significantly lower in the DEB group compared to the PES group (0.08 ± 0.38 mm vs. 0.29 ± 0.44 mm; difference -0.21 mm; 95% CI: -0.34 to -0.09; p < 0.001 for noninferiority, p = 0.001 for superiority).
- At 6 months, DEB and PES groups showed angiographic restenosis rates of 10% vs. 14.6% (p = 0.35), target lesion revascularization rates of 4.4% vs. 7.6% (p = 0.37), and major adverse cardiac event rates of 10% vs. 16.3% (p = 0.21).
- Bailout stenting was required in 20% of lesions treated with the drug-eluting balloon.
Study Design
Type
RCT (n=182)
Multicenter
Yes
Structured PICO
Does a paclitaxel drug-eluting balloon reduce angiographic late loss compared to a paclitaxel-eluting stent in patients with small coronary vessel lesions?
P
Population
182 patients with coronary lesions in small vessels (reference diameter <2.8 mm) followed for 6 months.
I
Intervention
Paclitaxel drug-eluting balloon (DEB) with provisional bare-metal stenting
C
Comparator
Paclitaxel-eluting stent (PES) implantation
O
Outcome
Angiographic in-stent (in-balloon) late loss (noninferiority with a delta of 0.25 mm)surrogate
Main Result
Mean Difference: -0.21 (95% CI -0.34–-0.09)
Absolute Event Rate: 0.08% vs 0.29%
p-value: p=<0.001 for noninferiority; 0.001 for superiority
Treatment of small-vessel coronary disease with a paclitaxel drug-eluting balloon is superior to a paclitaxel-eluting stent in reducing angiographic late loss, with similar rates of restenosis and revascularization at 6 months.
Cite This Study
Latib et al. (2012) conducted an RCT in Small coronary vessel disease (n=182). Paclitaxel drug-eluting balloon (DEB) with provisional bare-metal stenting vs. Paclitaxel-eluting stent (PES) was evaluated on angiographic in-stent (in-balloon) late loss (MD -0.21, 95% CI -0.34 to -0.09, p=<0.001 for noninferiority; 0.001 for superiority). A paclitaxel drug-eluting balloon was superior to a paclitaxel-eluting stent for angiographic late loss in small coronary vessels (difference -0.21 mm; 95% CI -0.34 to -0.09; P=0.001 for superiority).