Comparison of vascular response to zotarolimus-eluting stent versus sirolimus-eluting stent: intravascular ultrasound results from ENDEAVOR III

Am Heart J. 2008 Jan;155(1):108-13. doi: 10.1016/j.ahj.2007.08.008. Epub 2007 Sep 14.

Abstract

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.

Publication types

  • Clinical Trial, Phase III
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Angioplasty, Balloon, Coronary / instrumentation*
  • Angioplasty, Balloon, Coronary / methods
  • Coronary Restenosis / prevention & control
  • Coronary Stenosis / diagnostic imaging
  • Coronary Stenosis / therapy*
  • Drug-Eluting Stents
  • Female
  • Follow-Up Studies
  • Humans
  • Male
  • Middle Aged
  • Probability
  • Reference Values
  • Risk Assessment
  • Sensitivity and Specificity
  • Single-Blind Method
  • Sirolimus / analogs & derivatives*
  • Sirolimus / therapeutic use*
  • Survival Rate
  • Time Factors
  • Treatment Outcome
  • Tunica Intima / diagnostic imaging
  • Tunica Intima / drug effects
  • Tunica Intima / pathology*
  • Ultrasonography, Interventional*
  • Vascular Patency / drug effects

Substances

  • zotarolimus
  • Sirolimus