Four-year clinical outcome of sirolimus- and paclitaxel-eluting stents compared to bare-metal stents for the percutaneous treatment of stable coronary artery disease

Catheter Cardiovasc Interv. 2010 Jul 1;76(1):41-9. doi: 10.1002/ccd.22533.

Abstract

Background: There are limited data on the long-term safety and efficacy profile of coronary stent implantation in patients with stable coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI).

Objective: We aimed to assess the 4-year clinical outcome in patients who received a bare-metal stent (BMS), sirolimus-eluting stent (SES), or a paclitaxel-eluting stent (PES) for the percutaneous treatment of stable angina in our center during 2000-2005.

Methods: In the study period, a total of 2,449 consecutive patients (BMS = 1,005; SES = 373; and PES = 1071) underwent a PCI as part of three historical PCI-cohorts for stable angina and were routinely followed for the occurrence of major adverse cardiac events (MACE).

Results: At 4 years follow-up, 264 BMS patients (26.8%) had a MACE, compared to 75 SES patients (20.9%) and 199 PES patients (23.9%). Multivariate analysis showed that SES and PES were superior to BMS with respect to MACE [hazard ratio (HR) = 0.62, 95% confidence interval (CI): 0.47-0.81; HR = 0.67, 95% CI: 0.55-0.82, respectively]. The occurrence of MACE was significantly lower in the SES and PES population, primarily due to less target-vessel revascularization (TVR) procedures (HR = 0.53, 95% CI: 0.37-0.75; HR = 0.71, 95% CI: 0.62-0.81, respectively). The occurrence of early, late, and very late stent thrombosis was equally rare with each stent type. There were no significant differences between SES and PES on death, myocardial infarction, TVR, and MACE.

Conclusion: These findings suggest that SES and PES result in decreased TVR procedures and MACE compared to BMS at 4 years follow-up. SES or PES implantation should be the preferred choice over BMS for patients with stable CAD undergoing PCI.

Publication types

  • Comparative Study

MeSH terms

  • Aged
  • Angioplasty, Balloon, Coronary / adverse effects
  • Angioplasty, Balloon, Coronary / instrumentation*
  • Angioplasty, Balloon, Coronary / mortality
  • Cardiovascular Agents / administration & dosage*
  • Coronary Artery Disease / mortality
  • Coronary Artery Disease / therapy*
  • Drug-Eluting Stents*
  • Female
  • Humans
  • Kaplan-Meier Estimate
  • Male
  • Metals*
  • Middle Aged
  • Myocardial Infarction / etiology
  • Netherlands
  • Paclitaxel / administration & dosage*
  • Platelet Aggregation Inhibitors / therapeutic use
  • Proportional Hazards Models
  • Prosthesis Design
  • Registries
  • Risk Assessment
  • Risk Factors
  • Sirolimus / administration & dosage*
  • Stents*
  • Thrombosis / etiology
  • Time Factors
  • Treatment Outcome

Substances

  • Cardiovascular Agents
  • Metals
  • Platelet Aggregation Inhibitors
  • Paclitaxel
  • Sirolimus