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

R Michael Kirchner1, J Dawn Abbott

  • 1Department of Cardiology, Rhode Island Hospital, Brown Medical School, Providence, RI 02903, USA.

Insights

Drug-eluting stents (DES) significantly reduce restenosis compared to bare metal stents. The Xience V stent demonstrated efficacy and safety in the SPIRIT trial program, offering improved outcomes in interventional cardiology.

Area of Science:

  • Interventional Cardiology
  • Biomedical Engineering
  • Clinical Trials

Background:

  • Drug-eluting stents (DES) have revolutionized interventional cardiology by reducing restenosis and target vessel revascularization compared to bare metal stents.
  • Several DES are available, including first-generation sirolimus-eluting and paclitaxel-eluting stents, and second-generation everolimus-eluting and zotarolimus-eluting stents.

Purpose of the Study:

  • To provide a comprehensive assessment of the Xience V everolimus-eluting stent.
  • To review data from pre- and post-approval randomized controlled trials and registry studies within the SPIRIT clinical trial program.
  • To discuss the implications of mid-term outcomes for interventional practice.

Main Methods:

  • Analysis of data from the SPIRIT clinical trial program, including randomized controlled trials and registry studies.
  • Assessment of pre- and post-approval data for the Xience V stent.
  • Review of recently published mid-term outcomes.

Main Results:

  • The Xience V stent was approved based on clinical efficacy and safety data from the SPIRIT trials.
  • In the SPIRIT trials, Xience V was superior to the Vision bare metal stent for target vessel failure at 9 months.
  • Xience V was noninferior to the paclitaxel-eluting stent for target vessel failure at 9 months.

Conclusions:

  • The Xience V stent has demonstrated significant clinical efficacy and safety.
  • Data from the SPIRIT clinical trial program support the use of Xience V in interventional cardiology.
  • Mid-term outcomes continue to support the role of Xience V in improving patient care.

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