Introduction:
Drug eluting balloons (DEB) were recently approved by FDA for peripheral artery interventions only. For coronary in-stent restenosis (ISR), the ACC/AHA/SCAI 2011 PCI guidelines have no recommendations on role for DEB. While ESC/EACTS 2010 PCI guidelines, have level IIa recommendation for DEB for ISR after a bare metal stent. The drug delivery kinetics with DEB allows shorter duration of dual anti-platelet therapy and has a potential role in ballooning side branches of a bifurcating lesion after stenting.
Aim:
To compare safety and efficacy of DEB angioplasty vs. plain old balloon angioplasty (BA) or drug eluting stent (DES) for treating coronary ISR.
Methods and Results:
A thorough search was performed on Pubmed, Embace and Google scholar databases for randomized control trials (RCT) comparing DEB vs. BA or DES for ISR. We compared target lesion revascularization (TLR) and MACE events for these groups. We also pooled data from registries and observation studies on DEB for outcome analysis.
Total number of patients with DEB’s in our study was 3465, with 693 DEB’s in 8 RCT’s. Mean follow up period was 11 months. Pooled analysis showed significant benefit for DEB compared to plain old BA, for events of target lesion revascularization (OR= 0.25, p<0.0001), and death (OR=0.31, p<0.0001). Comparing DEB to DES, there was no statistical difference in outcomes comparing TLR (OR=1.4, p=0.14), MI or death (OR=0.65, p=0.39). Cumulative incidence of target lesion revascularization (TLR) with DEB was 6.7%.
Conclusions:
For coronary ISR, drug eluting balloon angioplasty is superior to plain old balloon angioplasty in terms of safety and outcomes. However, comparing drug eluting balloons vs. drug eluting stents in ISR, the outcomes are comparable and will need larger studies powered to make definitive recommendation.
Clinical Outcomes of Drug-Eluting versus Bare-Metal In-Stent Restenosis after the Treatment of Drug-Eluting Stent or Drug-Eluting Balloon: A Systematic Review and Meta-Analysis
