Long-term safety and efficacy of paclitaxel-eluting stents: Final 5-year analysis from the TAXUS clinical trial program

Gregg W. Stone, Stephen G. Ellis, Antonio Colombo, Eberhard Grube, Jeffrey J. Popma, Takahiro Uchida, Jill S. Bleuit, Keith D. Dawkins, Mary E. Russell

Research output: Contribution to journalArticlepeer-review

Abstract

Objectives: These studies sought to evaluate the clinical outcomes of the slow-release Taxus paclitaxel-eluting stent (PES) versus an otherwise identical bare-metal stent (BMS). Background: Prior studies were not individually powered to generate reliable estimates of low-frequency safety endpoints or to characterize the long-term safety and efficacy profile of PES. Methods: The completed 5-year databases from the prospective, randomized, double-blind TAXUS I, II, IV, and V trials were pooled for a patient-level analysis. Results: The study population comprised 2,797 randomized patients (1,400 PES and 1,397 BMS). At the end of the 5-year study period, PES compared with BMS significantly reduced the rate of ischemia-driven target lesion revascularization (12.3% vs. 21.0%, p <0.0001), with consistent reductions across high-risk subgroups and in patients with and without routine angiographic follow-up. There were no significant differences between the stent types in the 1-year or cumulative 5-year rates of death or myocardial infarction (MI). However, cardiac death or MI between 1 and 5 years was increased with PES (6.7% vs. 4.5%, p = 0.01), as was stent thrombosis (protocol definition: 0.9% vs. 0.2%, p = 0.007; ARC definition: 1.4% vs. 0.9%, p = 0.18). Conclusions: In this pooled patient-level analysis from the prospective, randomized, double-blind TAXUS trials, PES compared with BMS resulted in a durable 47% reduction in the 5-year rate of ischemia-driven target lesion revascularization in simple and complex lesions, with nonsignificant differences in the cumulative 5-year rates of death or MI. Between 1 and 5 years, however, the rates of cardiac death or MI and protocol-defined stent thrombosis were increased with PES.

Original languageEnglish
Pages (from-to)530-542
Number of pages13
JournalJACC: Cardiovascular Interventions
Volume4
Issue number5
DOIs
Publication statusPublished - May 2011

Keywords

  • bare-metal stent(s)
  • drug-eluting stent(s)
  • myocardial infarction
  • target lesion revascularization
  • target vessel revascularization

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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