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

Department

Medicine

Document Type

Article

Publication Title

Cardiovascular Revascularization Medicine

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.

First Page

612

Last Page

618

DOI

10.1016/j.carrev.2018.08.010

Volume

20

Issue

7

Publication Date

7-1-2019

Medical Subject Headings

Aged; Angioplasty, Balloon, Coronary (adverse effects, instrumentation, mortality); Cardiac Catheters; Cardiovascular Agents (administration & dosage, adverse effects); Coated Materials, Biocompatible; Coronary Artery Disease (diagnostic imaging, mortality, physiopathology, therapy); Coronary Restenosis (diagnostic imaging, mortality, physiopathology, therapy); Drug-Eluting Stents; Everolimus (administration & dosage, adverse effects); Female; Humans; Male; Middle Aged; Percutaneous Coronary Intervention (adverse effects, instrumentation, mortality); Prosthesis Design; Randomized Controlled Trials as Topic; Risk Factors; Stents; Time Factors; Treatment Outcome

PubMed ID

30126824

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