Update on the everolimus-eluting coronary stent system: results and implications from the SPIRIT clinical trial program

Vasc Health Risk Manag. 2009:5:1089-97. doi: 10.2147/vhrm.s5618. Epub 2009 Dec 29.

Abstract

Drug-eluting stents (DES) have had a major impact in interventional cardiology. Compared to bare metal stents, they significantly reduce restenosis and the need for target vessel revascularization. Four DES are available in the US, the first-generation sirolimus-eluting (Cypher((R))) and paclitaxel-eluting (Taxus((R))) stents and later approved second-generation everolimus-eluting (Xience V((R))) and zotarolimus-eluting (Endeavor((R))) stents. The Xience V stent was approved on the basis of clinical efficacy and safety data from 3 studies in the SPIRIT clinical trial program. Within this trial series, the Xience V was superior to its bare metal stent counterpart, the Vision(R) stent, and noninferior to the paclitaxel-eluting stent for target vessel failure at 9 months. This review provides a comprehensive assessment of the data derived from both the pre- and post-approval randomized controlled trials and registry studies of Xience V that comprise the SPIRIT clinical trial program including recently published mid-term outcomes. The implications of the results in terms of interventional practice will be discussed.

Keywords: Xience V; cobalt-chromium; drug-eluting stent; everolimus; percutaneous coronary intervention.

Publication types

  • Review

MeSH terms

  • Angioplasty, Balloon, Coronary / adverse effects
  • Angioplasty, Balloon, Coronary / instrumentation*
  • Angioplasty, Balloon, Coronary / mortality
  • Cardiovascular Agents / administration & dosage*
  • Drug-Eluting Stents*
  • Everolimus
  • Evidence-Based Medicine
  • Female
  • Humans
  • Male
  • Multicenter Studies as Topic
  • Prospective Studies
  • Prosthesis Design
  • Randomized Controlled Trials as Topic
  • Registries
  • Sirolimus / administration & dosage
  • Sirolimus / analogs & derivatives*
  • Time Factors
  • Treatment Outcome

Substances

  • Cardiovascular Agents
  • Everolimus
  • Sirolimus