Drug-eluting balloon versus second generation drug eluting stents in the treatment of in-stent restenosis: a systematic review and meta-analysis

Abstract

Introduction: In-stent restenosis (ISR) remains a significant mode of stent failure following PCI. Analyses on the available therapies however have been heterogeneous in nature and the optimal management for ISR remains undefined. Methods: A meta-analysis was performed to examine the efficacy of drug-eluting balloon (DEB) in the treatment of ISR specifically in comparison with second generation drug eluting stents (DES). Results: 6 studies comprising of 756 patients were included for analysis. The follow-up period ranges from 12-24 months. The use of DEB is associated with a significantly less acute gain in minimal luminal diameter (MLD) following PCI (-0.45, 95% CI: -0.70- -0.20mm), a strong trend towards higher late loss in MLD (0.10, -0.02-0.21mm) and a higher binary restenosis rate at follow-up (Risk ratio: 2.49, 1.45-4.26). However, there is no significant difference in the overall incidence of MACE, MI, TLR, or TVR between the two groups. There is a significantly higher incidence of all-cause mortality (RR: 2.08, 1.04-4.15) and a trend towards more cardiovascular death (RR: 2.27, 0.68-7.55) with DEB compared with DES. Selection bias however needs to be considered due to the observational nature of some studies included. Conclusion: DEB provides similar clinical results as compared with second generation DES in the treatment of ISR, although DES provides better acute and late angiographic results. DEB may be a reasonable alternative to DES in patients with ISR who are unable to tolerate long-term dual antiplatelet therapy. The long-term implications of these findings however remain to be determined.