Two-year results of an open-label randomized comparison of everolimus-eluting stents and sirolimus-eluting stents

PLoS One. 2013 Jun 3;8(6):e64424. doi: 10.1371/journal.pone.0064424. Print 2014.


Background: Second generation drug-eluting stents were developed to improve the safety and efficacy of first generation stents. So far, limited long term randomized data exist comparing the second generation everolimus-eluting stents (EES) with first generation sirolimus-eluting stents (SES).

Methods: A prospective, open-label, randomized, single center trial comparing EES and SES in all-comer patients. The primary endpoint was a composite of cardiac mortality, myocardial infarction and target vessel revascularization. Secondary endpoints included individual components of the composite, along with target lesion revascularization and stent thrombosis.

Results: In total, 977 patients were randomized, of which 498 patients to EES and 479 to SES. Average age was 65.2 ± 11.2 years and 71.6% of the population was male. Fifty percent of patients were treated for acute coronary syndrome, more often for ST-elevation myocardial infarctions in EES patients (13.7% vs. 9.2% in SES). In contrast, SES patients more often had prior interventions and showed more calcified lesions. Two-year follow-up was available in 98% of patients. The primary endpoint occurred in 10.7% of EES patients compared to 10.6% of SES patients (HR 1.00, 95% CI 0.68-1.48). Additionally, secondary endpoints were similar between groups. The rate of stent thrombosis was low for both stent types.

Conclusion: In this all-comer population, there were no differences in endpoints between EES and SES during two-year follow-up. Stent thrombosis rates were low, supporting the safety of drug-eluting stent appliance in clinical practice.

Trial registration: NTR3170.

Publication types

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

MeSH terms

  • Aged
  • Coronary Angiography
  • Drug-Eluting Stents*
  • Everolimus
  • Female
  • Humans
  • Male
  • Sirolimus / analogs & derivatives*
  • Sirolimus / therapeutic use*
  • Treatment Outcome


  • Everolimus
  • Sirolimus

Grant support

The Cardiology Research Foundation of the Medical Center Leeuwarden received a unrestricted research grant from Abbott Vascular. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.