Paclitaxel-eluting versus uncoated stents in primary percutaneous coronary intervention

N Engl J Med. 2006 Sep 14;355(11):1105-13. doi: 10.1056/NEJMoa062598.

Abstract

Background: Drug-eluting coronary-artery stents have been shown to decrease restenosis and therefore the likelihood that additional procedures will be required after percutaneous coronary intervention (PCI). We evaluated the use of a drug-eluting stent in patients undergoing PCI for acute myocardial infarction with ST-segment elevation.

Methods: We randomly assigned 619 patients presenting with an acute myocardial infarction with ST-segment elevation to receive either a paclitaxel-eluting stent or an uncoated stent. The primary end point was a composite of death from cardiac causes, recurrent myocardial infarction, or target-lesion revascularization at 1 year.

Results: Baseline clinical and angiographic characteristics in both groups were well matched. There was a trend toward a lower rate of serious adverse events in the paclitaxel-stent group than in the uncoated-stent group (8.8% vs. 12.8%; adjusted relative risk, 0.63; 95% confidence interval, 0.37 to 1.07; P=0.09). A nonsignificant trend was also detected in favor of the paclitaxel-stent group, as compared with the uncoated-stent group, in the rate of death from cardiac causes or recurrent myocardial infarction (5.5% vs. 7.2%, P=0.40) and in the rate of target-lesion revascularization (5.3% vs. 7.8%, P=0.23). The incidence of stent thrombosis during 1 year of follow-up was the same in both groups (1.0%).

Conclusions: Although the use of paclitaxel-eluting stents in acute myocardial infarction with ST-segment elevation reduced the incidence of serious adverse cardiac events at 1 year by 4.0 percentage points, as compared with uncoated stents, the difference was not statistically significant. (Current Controlled Trials number, ISRCTN65027270 [controlled-trials.com].).

Publication types

  • Comment
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Angioplasty, Balloon, Coronary*
  • Combined Modality Therapy
  • Coronary Angiography
  • Coronary Artery Bypass
  • Disease-Free Survival
  • Female
  • Follow-Up Studies
  • Humans
  • Immunosuppressive Agents / administration & dosage*
  • Male
  • Middle Aged
  • Myocardial Infarction / mortality
  • Myocardial Infarction / therapy*
  • Paclitaxel / administration & dosage*
  • Platelet Glycoprotein GPIIb-IIIa Complex / antagonists & inhibitors
  • Proportional Hazards Models
  • Risk
  • Secondary Prevention
  • Single-Blind Method
  • Stents*
  • Thrombosis / epidemiology

Substances

  • Immunosuppressive Agents
  • Platelet Glycoprotein GPIIb-IIIa Complex
  • Paclitaxel

Associated data

  • ISRCTN/ISRCTN65027270