Everolimus-eluting versus paclitaxel-eluting stents in coronary artery disease

N Engl J Med. 2010 May 6;362(18):1663-74. doi: 10.1056/NEJMoa0910496.


Background: Previous studies have established the superiority of coronary everolimus-eluting stents over paclitaxel-eluting stents with respect to angiographic findings. However, these trials were not powered for superiority in clinical end points.

Methods: We randomly assigned 3687 patients at 66 U.S. sites to receive everolimus-eluting stents or paclitaxel-eluting stents without routine follow-up angiography. The primary end point was the 1-year composite rate of target-lesion failure (defined as cardiac death, target-vessel myocardial infarction, or ischemia-driven target-lesion revascularization).

Results: Everolimus-eluting stents were superior to paclitaxel-eluting stents with respect to the primary end point of target-lesion failure (4.2% vs. 6.8%; relative risk, 0.62; 95% confidence interval, 0.46 to 0.82; P=0.001). Everolimus-eluting stents were also superior with respect to the major secondary end point of the 1-year rate of ischemia-driven target-lesion revascularization (P=0.001) and were noninferior with respect to the major secondary end point of the 1-year composite rate of cardiac death or target-vessel myocardial infarction (P<0.001 for noninferiority; P=0.09 for superiority). The 1-year rates of myocardial infarction and stent thrombosis were also lower with everolimus-eluting stents than with paclitaxel-eluting stents (1.9% vs. 3.1%, P=0.02 for myocardial infarction; 0.17% vs. 0.85%, P=0.004 for stent thrombosis). Target-lesion failure was consistently reduced with everolimus-eluting stents as compared with paclitaxel-eluting stents in 12 prespecified subgroups, except in the subgroup of patients with diabetes (6.4% vs. 6.9%, P=0.80).

Conclusions: Everolimus-eluting stents, as compared with paclitaxel-eluting stents, resulted in reduced rates of target-lesion failure at 1 year, results that were consistent in all patients except those with diabetes, in whom the results were nonsignificantly different. (ClinicalTrials.gov number, NCT00307047.)

Publication types

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

MeSH terms

  • Aged
  • Angioplasty, Balloon, Coronary
  • Coronary Artery Disease / mortality
  • Coronary Artery Disease / therapy*
  • Drug-Eluting Stents* / adverse effects
  • Everolimus
  • Female
  • Humans
  • Logistic Models
  • Male
  • Middle Aged
  • Myocardial Infarction / epidemiology
  • Paclitaxel / administration & dosage*
  • Platelet Glycoprotein GPIIb-IIIa Complex / antagonists & inhibitors
  • Retreatment / statistics & numerical data
  • Single-Blind Method
  • Sirolimus / administration & dosage
  • Sirolimus / analogs & derivatives*
  • Thrombosis / epidemiology
  • Thrombosis / prevention & control
  • Treatment Failure


  • Platelet Glycoprotein GPIIb-IIIa Complex
  • Everolimus
  • Paclitaxel
  • Sirolimus

Associated data

  • ClinicalTrials.gov/NCT00307047