Background:
In-stent restenosis accounts for major morbidity and mortality among patients treated with Bare-Metal Stents (BMS). Early efforts to treat BMS in-stent restenosis with plain balloon angioplasty and first generation drug eluting stents (DES) have been ineffective, leaving drug-eluting balloon (DEB) and second generation DES, such as everolimus eluting stents (EES), as the only remaining options. For BMS in-stent restenosis, studies performed so far have yielded conflicting results, while prior meta-analyses have been influenced by inclusion of observational studies. This is the first meta-analysis to compare EES versus DEB using results from only randomized controlled trials (RCTs).
Methods:
A systematic search of PUBMED and EMBASE databases was conducted from first available date to August, 2016 for RCTs comparing DEB with EES. Two reviewers evaluated studies for eligibility and extracted data with binary restenosis rate as the main endpoint. We identified 901 unique citations. Odds ratios were pooled using random-effects modeling. Funnel plots were used to assess publication bias. Heterogeneity was assessed using I
2
statistic. All analysis were performed using Review Manager (RevMan) version 5.3 (Cochrane Collaboration, 2014).
Results:
Three RCTs met study eligibility criteria, with 684 patients and a mean follow-up of 9.5 months. There were 184 and 185 patients in the EES and DEB arms respectively. In pooled analyses, EES was not superior to DEB in binary restenosis rates (pooled odds ratio: 0.76; 95% confidence interval: 0.25-2.32; P=0.14). Heterogeneity was minimal (I
2
= 49%), and the funnel plot did not suggest publication bias.
Conclusion:
In patients with BMS in-stent restenosis, there were no significant differences in binary restenosis rates between EES and DEB. Our results can enhance physician decision-making regarding choice of revascularization tool in this patient population.
Drug-eluting stents versus bare-metal stents for treatment of bare-metal in-stent restenosis