Sirolimus-eluting and paclitaxel-eluting stents for coronary revascularization

N Engl J Med. 2005 Aug 18;353(7):653-62. doi: 10.1056/NEJMoa051175. Epub 2005 Aug 16.


Background: Sirolimus-eluting stents and paclitaxel-eluting stents, as compared with bare-metal stents, reduce the risk of restenosis. It is unclear whether there are differences in safety and efficacy between the two types of drug-eluting stents.

Methods: We conducted a randomized, controlled, single-blind trial comparing sirolimus-eluting stents with paclitaxel-eluting stents in 1012 patients undergoing percutaneous coronary intervention. The primary end point was a composite of major adverse cardiac events (death from cardiac causes, myocardial infarction, and ischemia-driven revascularization of the target lesion) by nine months. Follow-up angiography was completed in 540 of 1012 patients (53.4 percent).

Results: The two groups had similar baseline clinical and angiographic characteristics. The rate of major adverse cardiac events at nine months was 6.2 percent in the sirolimus-stent group and 10.8 percent in the paclitaxel-stent group (hazard ratio, 0.56; 95 percent confidence interval, 0.36 to 0.86; P=0.009). The difference was driven by a lower rate of target-lesion revascularization in the sirolimus-stent group than in the paclitaxel-stent group (4.8 percent vs. 8.3 percent; hazard ratio, 0.56; 95 percent confidence interval, 0.34 to 0.93; P=0.03). Rates of death from cardiac causes were 0.6 percent in the sirolimus-stent group and 1.6 percent in the paclitaxel-stent group (P=0.15); the rates of myocardial infarction were 2.8 percent and 3.5 percent, respectively (P=0.49); and the rates of angiographic restenosis were 6.6 percent and 11.7 percent, respectively (P=0.02).

Conclusions: As compared with paclitaxel-eluting stents, the use of sirolimus-eluting stents results in fewer major adverse cardiac events, primarily by decreasing the rates of clinical and angiographic restenosis.

Publication types

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

MeSH terms

  • Angioplasty, Balloon, Coronary
  • Coronary Angiography
  • Coronary Disease / mortality
  • Coronary Disease / therapy*
  • Coronary Restenosis / epidemiology
  • Coronary Restenosis / prevention & control*
  • Coronary Restenosis / therapy
  • Female
  • Follow-Up Studies
  • Humans
  • Immunosuppressive Agents / administration & dosage*
  • Male
  • Middle Aged
  • Myocardial Infarction / epidemiology
  • Paclitaxel / administration & dosage*
  • Proportional Hazards Models
  • Single-Blind Method
  • Sirolimus / administration & dosage*
  • Stents*
  • Survival Analysis


  • Immunosuppressive Agents
  • Paclitaxel
  • Sirolimus