Elsevier

American Heart Journal

Volume 155, Issue 1, January 2008, Pages 108-113
American Heart Journal

Clinical Investigation
Interventional Cardiology
Comparison of vascular response to zotarolimus-eluting stent versus sirolimus-eluting stent: Intravascular ultrasound results from ENDEAVOR III

https://doi.org/10.1016/j.ahj.2007.08.008Get rights and content

Background

The purpose of this study was to investigate the vascular response of zotarolimus-eluting stent (ZES) and sirolimus-eluting stent (SES) using serial intravascular ultrasound (IVUS).

Methods

Data were obtained from the Endeavor Drug-Eluting Coronary Stent System Versus the Center Siromlimus-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions (ENDEAVOR) III trial, a randomized study comparing ZES and SES for the treatment of de novo native coronary artery lesions. Serial (baseline and 8-month follow-up) IVUS was available in 258 patients (190 ZES, 68 SES).

Results

At 8 months, ZES had greater percentage of neointimal volume index (ZES 1.1 ± 0.8 mm3/mm vs SES 0.2 ± 0.1 mm3/mm, P < .01), resulting in smaller lumen volume index (6.0 ± 2.0 mm3/mm vs 7.0 ± 2.1 mm3/mm, P < .05). Zotarolimus-eluting stents showed larger IVUS-detectable neointimal coverage over stent surface (50.2% vs 10.5%, P < .01) and greater mean neointimal thickness (0.19 ± 0.07 mm vs 0.10 ± 0.06 mm, P < .01). Zotarolimus-eluting stents had a significantly lower incidence of late-acquired incomplete stent apposition.

Conclusions

Zotarolimus-eluting stent is associated with a significantly greater amount of neointimal hyperplasia compared with SES. This amount of hyperplasia in ZES is distributed throughout the stent at 8-month follow-up.

Section snippets

Patients

Data were derived from the Endeavor Drug-Eluting Coronary Stent System Versus the Center Siromlimus-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions (ENDEAVOR) III trial, a multicenter, single-blind, parallel, 2-arm, randomized control study comparing the efficacy between ZES and SES for the treatment of de novo coronary artery lesions.1 Patients were randomized to either ZES or SES in a 3:1 fashion. The study protocol was approved by the institutional review board at

Study population and patient characteristics

Intravascular ultrasound images were obtained in 296 cases (ZES 222, SES 74) at 8-month follow-up analysis, with 258 cases (ZES 190, SES 68) available for serial (baseline and 8-month follow-up) analysis. Because of inconsistent pullback or inadequate image quality, 48 cases (ZES 35, SES 13) were excluded from volumetric analysis. Patient, lesion, and procedural characteristics are shown in Table I. Except for the higher percentage of men and the lower maximum balloon pressure in the ZES group,

Discussion

This IVUS analysis has shown that ZES had greater amount of neointima compared with SES. Zotarolimus-eluting stents also showed larger IVUS-detectable neointimal coverage over stent surface evenly distributed throughout its length and lower incidence of late-acquired ISA.

Cited by (80)

  • Medical Device Technologies: A Systems Based Overview Using Engineering Standards

    2020, Medical Device Technologies: A Systems Based Overview Using Engineering Standards
  • Drug-eluting biostable and erodible stents

    2014, Journal of Controlled Release
View all citing articles on Scopus

Drs. Miyazawa and Ako contributed equally to this work.

This study was supported by Medtronic Inc, Santa Rosa, CA.

View full text