Outcomes with the paclitaxel-eluting stent in patients with acute coronary syndromes: analysis from the TAXUS-IV trial

J Am Coll Cardiol. 2005 Apr 19;45(8):1165-71. doi: 10.1016/j.jacc.2004.10.074.

Abstract

Objectives: We sought to investigate the outcomes of paclitaxel-eluting stent implantation in patients with unstable angina or non-ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention (PCI).

Background: Whether the paclitaxel-eluting stent is safe and effective in patients with acute coronary syndromes (ACS) is unknown.

Methods: In the TAXUS-IV trial, 1,314 patients with stable or unstable ischemic syndromes undergoing PCI were randomized to treatment with either the slow-release, polymer-based, paclitaxel-eluting TAXUS stent or a bare-metal EXPRESS stent (Boston Scientific Corp., Natick, Massachusetts). The results were stratified by the acuity of the presenting clinical syndrome.

Results: Acute coronary syndromes were present in 450 patients (34.2%), 237 of whom were assigned to paclitaxel-eluting stents and 213 to bare-metal stents. The baseline and procedural characteristics were well matched between the groups. Clinical outcomes at 30 days were similar with both stents. At one-year follow-up, patients with ACS assigned to the paclitaxel-eluting stent compared to the control stent had strikingly lower rates of target lesion revascularization (TLR) (3.9% vs. 16.0%, p < 0.0001) and major adverse cardiac events (11.1 vs. 21.7%, p = 0.002). By multivariate analysis, ACS was an independent predictor of in-stent restenosis in the cohort treated with bare-metal stents (hazard ratio [HR] = 2.03 [95% confidence interval (CI) 1.05 to 3.92], p = 0.035), while among patients randomized to the paclitaxel-eluting stents, ACS was an independent predictor of freedom from restenosis (HR = 0.27 [95% CI 0.08 to 0.97], p = 0.04).

Conclusions: The use of the paclitaxel-eluting TAXUS stent was safe in patients with unstable ischemic syndromes, and was associated with marked reduction of ischemia-driven TLR and adverse cardiac events at one year.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase IV
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Antineoplastic Agents / administration & dosage*
  • Coronary Disease / therapy*
  • Coronary Restenosis / prevention & control
  • Double-Blind Method
  • Female
  • Follow-Up Studies
  • Humans
  • Male
  • Microvascular Angina / therapy
  • Middle Aged
  • Myocardial Revascularization
  • Paclitaxel / administration & dosage*
  • Prospective Studies
  • Stents*

Substances

  • Antineoplastic Agents
  • Paclitaxel