• Drug-Eluting Balloons Versus Everolimus-Eluting Stents for In-Stent Restenosis: A Meta-Analysis of Randomized Trials

    Highlights

    • Randomized trials comparing DEB versus EES for ISR were underpowered for clinical end-points.
    • This meta-analysis of 5 trials showed that DEB was associated with an increased risk of TVR and TLR at longer follow-up for any ISR.
    • The quality of evidence was moderate suggesting the need for further randomized trials with longer follow-up.

    Abstract

    Objectives

    Individual randomized trials comparing drug-eluting balloons (DEB) versus everolimus-eluting stents (EES) for in-stent restenosis (ISR) were underpowered for clinical end-points. The objective of this study was to compare the clinical outcomes of DEB versus EES for any ISR.

    Materials & methods

    Electronic databases were searched for randomized trials which compared DEB versus EES for any ISR (i.e., drug eluting or bare metal stents). Summary estimate risk ratios (RRs) were constructed using a DerSimonian and Laird random effects model.

    Results

    Five trials with 962 patients were included. In-segment minimum lumen diameter (MLD) was lower with DEB (standardized mean difference −0.24, 95% confidence interval [CI] −0.46 – −0.01) on angiographic follow-up at a mean of 8.6 months. There was no statistically significant difference in the risk of target vessel revascularization(TVR) at 1 year (RR 1.15, 95% CI 0.60–2.19), but TVR was increased with DEB at 3 years (RR 1.87, 95% CI 1.15–3.03). The risk of target lesion revascularization (TLR) was statistically increased with DEB (RR 2.17, 95% CI 1.13–4.19) at a mean of 24.4 months. There was no difference in the risk of MI, stent thrombosis, cardiac mortality and all-cause mortality between both groups.

    Conclusion

    In patients with any type of ISR, DEB was associated a similar risk of TVR at 1-year, but increased risk of TVR and TLR at longer follow-up, as compared with EES. The quality of evidence was moderate, suggesting the need for further randomized trials with longer follow-up to confirm the role of DEB in the management of ISR.

    Author bio

    Cardiovascular Revascularization Medicine, 2019-07-01, Volume 20, Issue 7, Pages 612-618, Copyright © 2018 Elsevier Inc.

     

    Source:

    Read the full article on Science Direct: Drug-Eluting Balloons Versus Everolimus-Eluting Stents for In-Stent Restenosis: A Meta-Analysis of Randomized Trials

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