A Randomized Comparison of Drug-Eluting Balloon Versus Everolimus-Eluting Stent in Patients With Bare-Metal Stent–In-Stent Restenosis
Key result
DEB yields ~0.35 mm smaller minimal lumen diameter at 9 months compared to EES.
- MD 0.35
- 95% CI 0.16 to 0.53
- P<0.001
- n=189
Why the study?
Treatment of patients with bare-metal stent in-stent restenosis remains a challenge and requires comparison of drug-eluting balloons versus everolimus-eluting stents.
Does paclitaxel-eluting balloon improve minimal lumen diameter compared to everolimus-eluting stent in patients with bare-metal stent in-stent restenosis?
Population
189 patients with bare-metal stent in-stent restenosis from 25 Spanish sites
Comparison
Drug-eluting balloon versus everolimus-eluting stent
Design
Prospective multicenter randomized trial
Follow-up
Median 249 days for angiography, median 365 days for clinical follow-up
Authors
Discussion
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Implication
In patients with bare-metal stent in-stent restenosis, everolimus-eluting stents provide superior late angiographic findings compared to paclitaxel-eluting balloons, though both yield excellent clinical results.
Key Points
- To compare the efficacy of drug-eluting balloons with everolimus-eluting stents in patients presenting with bare-metal stent in-stent restenosis.
- Prospective, multicenter, randomized trial (RIBS V; NCT01239953) conducted across 25 sites in Spain enrolling 189 patients with bare-metal stent in-stent restenosis.
- Patients were randomized to treatment with drug-eluting balloons (n = 95) or everolimus-eluting stents (n = 94).
- Angiographic follow-up was evaluated at a median of 249 days (primary endpoint: minimal lumen diameter), with clinical follow-up evaluated at a median of 365 days.
- At 9 months, everolimus-eluting stents achieved a significantly larger minimal lumen diameter compared with drug-eluting balloons (2.36 ± 0.6 mm vs. 2.01 ± 0.6 mm; absolute mean difference: 0.35 mm; 95% CI: 0.16 to 0.53; p < 0.001) and lower diameter stenosis (13 ± 17% vs. 25 ± 20%, p < 0.001).
- Angiographic late loss (0.04 ± 0.5 mm vs. 0.14 ± 0.5 mm, p = 0.14) and binary restenosis rates (4.7% vs. 9.5%, p = 0.22) were not statistically significantly different between groups.
- At 1-year clinical follow-up, the composite outcome of cardiac death, myocardial infarction, and target vessel revascularization occurred in 8% of the everolimus-eluting stent arm versus 6% of the drug-eluting balloon arm (HR: 0.76; 95% CI: 0.26 to 2.18, p = 0.6).
Study Design
Type
RCT (n=189)
Multicenter
Yes
Structured PICO
Does paclitaxel-eluting balloon improve minimal lumen diameter compared to everolimus-eluting stent in patients with bare-metal stent in-stent restenosis?
P
Population
189 patients with bare-metal stent in-stent restenosis across 25 Spanish sites, followed for a median of 249 days angiographically and 365 days clinically.
I
Intervention
Paclitaxel-eluting balloon (DEB)
C
Comparator
Everolimus-eluting stent (EES)
O
Outcome
Minimal lumen diameter at 9 months' follow-upsurrogate
Main Result
Mean Difference: 0.35 (95% CI 0.16–0.53)
Absolute Event Rate: 2.01% vs 2.36%
p-value: p=<0.001
In patients with bare-metal stent in-stent restenosis, everolimus-eluting stents provide superior late angiographic findings compared to paclitaxel-eluting balloons, though both yield excellent clinical results.
Cite This Study
Alfonso et al. (2014) conducted an RCT in Bare-metal stent in-stent restenosis (n=189). Drug-eluting balloons (DEB) vs. Everolimus-eluting stents (EES) was evaluated on Minimal lumen diameter at 9 months' follow-up (MD 0.35, 95% CI 0.16 to 0.53, p=<0.001). Drug-eluting balloons resulted in a significantly smaller minimal lumen diameter at 9 months compared to everolimus-eluting stents (2.01 mm vs 2.36 mm; MD 0.35 mm; 95% CI 0.16-0.53; P<0.001).