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

Authors

Islam Y. Elgendy, Division of Cardiovascular Medicine, Department of Medicine, University of Florida, Gainesville, FL, United States of America.
Ahmed N. Mahmoud, Division of Cardiovascular Medicine, Department of Medicine, University of Florida, Gainesville, FL, United States of America.
Akram Y. Elgendy, Division of Cardiovascular Medicine, Department of Medicine, University of Florida, Gainesville, FL, United States of America.
Mohammad K. Mojadidi, Division of Cardiovascular Medicine, Department of Medicine, University of Florida, Gainesville, FL, United States of America.
Ayman Elbadawi, Rochester Regional HealthFollow
Parham Eshtehardi, Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, GA, United States of America.
María José Pérez-Vizcayno, Department of Cardiology, Hospital Universitario Clinico San Carlos, Fundación Interhospitalaria de Investigación Cardiovascular, Madrid, Spain.
Siddharth A. Wayangankar, Division of Cardiovascular Medicine, Department of Medicine, University of Florida, Gainesville, FL, United States of America.
Hani Jneid, Division of Cardiology, Baylor College of Medicine and the Michael E. DeBakey VA Medical Center, Houston, TX, United States of America.
R David Anderson, Division of Cardiovascular Medicine, Department of Medicine, University of Florida, Gainesville, FL, United States of America.
Fernando Alfonso, Department of Cardiology, Hospital Universitario de La Princesa, Universidad Autónoma de Madrid, IIS-IP, Madrid, Spain.

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

Recommended Citation

Elgendy, I. Y., Mahmoud, A. N., Elgendy, A. Y., Mojadidi, M. K., Elbadawi, A., Eshtehardi, P., Pérez-Vizcayno, M. J., Wayangankar, S. A., Jneid, H., David Anderson, R., & Alfonso, F. (2019). Drug-Eluting Balloons Versus Everolimus-Eluting Stents for In-Stent Restenosis: A Meta-Analysis of Randomized Trials. Cardiovascular Revascularization Medicine, 20 (7), 612-618. https://doi.org/10.1016/j.carrev.2018.08.010