Outcomes with the polymer-based paclitaxel-eluting TAXUS stent in patients with diabetes mellitus: the TAXUS-IV trial

J Am Coll Cardiol. 2005 Apr 19;45(8):1172-9. doi: 10.1016/j.jacc.2004.10.075.


Objectives: We sought to determine the safety and efficacy of polymer-regulated site-specific delivery of paclitaxel in patients with diabetes mellitus undergoing stent implantation.

Background: Percutaneous coronary intervention in patients with diabetes is associated with high rates of restenosis and repeat revascularization due to excessive neointimal proliferation, a process that may be blunted with the site-specific delivery of paclitaxel.

Methods: In the TAXUS-IV trial, 1,314 patients were prospectively randomized to the slow rate-release polymer-based paclitaxel-eluting TAXUS stent or the bare-metal EXPRESS stent (Boston Scientific Corp., Natick, Massachusetts). Medically treated diabetes was present in 318 patients (24%), 105 of whom required insulin.

Results: Among patients with diabetes, the TAXUS stent, compared to the bare-metal stent, reduced the rate of 9-month binary angiographic restenosis by 81% (6.4% vs. 34.5%, p < 0.0001), and reduced the 12-month rates of target lesion revascularization by 65% (7.4% vs. 20.9%, p = 0.0008), target vessel revascularization by 53% (11.3% vs. 24%, p < 0.004), and composite major adverse cardiac events by 44% (15.6% vs. 27.7%, p = 0.01). The one-year rates of cardiac death (1.9% vs. 2.5%), myocardial infarction (3.2% vs. 6.4%), and subacute thrombosis (0.6% vs. 1.2%) were comparable between the paclitaxel-eluting and control stents, respectively. In the insulin-requiring subgroup, the TAXUS stent reduced angiographic restenosis by 82% (7.7% vs. 42.9%, p = 0.0065), and reduced the one-year rate of target lesion revascularization by 68% (6.2% vs. 19.4%, p = 0.07), a relative reduction similar to patients without diabetes.

Conclusions: The site-specific delivery of paclitaxel after coronary stent implantation is highly effective in reducing clinical and angiographic restenosis in patients with diabetes mellitus.

Publication types

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

MeSH terms

  • Antineoplastic Agents / administration & dosage*
  • Coronary Restenosis / prevention & control*
  • Diabetes Complications / therapy*
  • Diabetes Mellitus / drug therapy
  • Diabetic Angiopathies / therapy
  • Female
  • Humans
  • Male
  • Middle Aged
  • Myocardial Revascularization
  • Paclitaxel / administration & dosage*
  • Polymers
  • Prospective Studies
  • Stents*
  • Treatment Outcome


  • Antineoplastic Agents
  • Polymers
  • Paclitaxel