Five-year long-term clinical follow-up of the XIENCE V everolimus-eluting coronary stent system in the treatment of patients with de novo coronary artery disease: the SPIRIT II trial

EuroIntervention. 2013 Jan 22;8(9):1047-51. doi: 10.4244/EIJV8I9A161.


Aims: To assess the safety and performance of the XIENCE V everolimus-eluting stent (EES) versus the TAXUS paclitaxel-eluting stent (PES) in the treatment of patients with de novo coronary artery lesions after a five-year follow-up period. Second-generation drug-eluting stents (DES) were developed with the aim of improving the safety profile of DES, after reports of stent thrombosis (ST) with first-generation devices. However, long-term follow-up data are scarce.

Methods and results: SPIRIT II was a multicentre, prospective, single-blind, clinical trial, randomising 300 patients with up to two de novo coronary artery lesions in a ratio of 3:1 to either a EES or a PES. The five-year clinical follow-up was completed in 244 patients (81%). At five-year follow-up, 19.5% of patients were on thienopyridine in the EES arm, while 30.5% were on the same therapy in the PES arm. Cardiac mortality was significantly lower in EES than in PES (1.5% vs. 7.3%, p=0.015). There was a trend towards lower cardiac death and MI (4.8% vs. 11.4%) and lower ID-TLR (4.7% vs. 9.4%) in EES than in PES. As a result, there was a consistent reduction in ID-MACE for EES vs. PES (ID-MACE 8.0% vs. 18.1%, p=0.018). In addition, the ARC-defined stent thrombosis rate was numerically lower in EES compared to PES (0.9% vs. 2.8%). No definite stent thrombosis events were observed after two years in the EES arm.

Conclusions: Five-year clinical follow-up of the SPIRIT II trial demonstrated the continuing long-term safety and efficacy of EES.

Trial registration: NCT00180310.

Publication types

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

MeSH terms

  • Aged
  • Coronary Artery Disease / therapy*
  • Drug-Eluting Stents* / adverse effects
  • Everolimus
  • Female
  • Follow-Up Studies
  • Humans
  • Incidence
  • Kaplan-Meier Estimate
  • Longitudinal Studies
  • Male
  • Middle Aged
  • Myocardial Infarction
  • Myocardial Ischemia
  • Paclitaxel*
  • Percutaneous Coronary Intervention / adverse effects
  • Percutaneous Coronary Intervention / methods*
  • Prospective Studies
  • Single-Blind Method
  • Sirolimus / analogs & derivatives*
  • Treatment Outcome


  • Everolimus
  • Paclitaxel
  • Sirolimus

Associated data