Long-term efficacy and safety of Zotarolimus-eluting stent in patients with diabetes mellitus: pooled 5-year results from the ENDEAVOR III and IV trials

Catheter Cardiovasc Interv. 2013 Dec 1;82(7):1031-8. doi: 10.1002/ccd.25045. Epub 2013 Jul 4.

Abstract

Objective: To assess long-term outcomes of Endeavor Zotarolimus-eluting stent (E-ZES) implantation in patients with diabetes mellitus (DM).

Background: Patients with DM and coronary artery disease have lower restenosis with drug-eluting stent (DES) compared with bare-metal stents. Recent data suggest that the E-ZES is inferior to other DES in this population.

Methods: Patient-level data for 601 patients with DM from the ENDEAVOR III and ENDEAVOR IV trials were pooled, of which 337 were treated with E-ZES and 264 were treated with other DES. The primary outcome was target vessel failure (TVF) in the course of 5 years. Outcomes are reported as rates using Kaplan-Meier (KM) survival method and differences between E-ZES and other stent types (sirolimus-eluting stent or paclitaxel-eluting stent) were compared using the log-rank statistic. The independent effect of stent type on TVF was assessed using Cox proportional hazards regression.

Results: Baseline characteristics were similar between the groups. Five-year TVF KM rate estimate was numerically lower for E-ZES, but the difference did not reach statistical significance (20.2 vs. 26.9%, P = 0.065). The 5-year KM rate estimates of major adverse cardiac events (17.7 vs. 26.6%, P = 0.012), death (7.6 vs. 15.0%, P = 0.004), and myocardial infarction (1.3 vs. 5.1%, P = 0.011) were also lower for E-ZES versus other DES.

Conclusions: Patients with DM implanted with E-ZES have favorable long-term outcomes compared to first-generation DES. Long-term performance of DES should be assessed routinely and may differ from initial performance.

Keywords: coronary artery disease; diabetes mellitus; drug-eluting stents.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Cardiovascular Agents / administration & dosage*
  • Coronary Artery Disease / diagnosis
  • Coronary Artery Disease / mortality
  • Coronary Artery Disease / therapy*
  • Coronary Restenosis / etiology
  • Coronary Restenosis / prevention & control
  • Diabetic Angiopathies / diagnosis
  • Diabetic Angiopathies / mortality
  • Diabetic Angiopathies / therapy*
  • Drug-Eluting Stents*
  • Female
  • Humans
  • Kaplan-Meier Estimate
  • Male
  • Middle Aged
  • Paclitaxel / administration & dosage
  • Percutaneous Coronary Intervention / adverse effects
  • Percutaneous Coronary Intervention / instrumentation*
  • Percutaneous Coronary Intervention / mortality
  • Proportional Hazards Models
  • Prospective Studies
  • Prosthesis Design
  • Risk Factors
  • Sirolimus / administration & dosage
  • Sirolimus / analogs & derivatives*
  • Time Factors
  • Treatment Outcome

Substances

  • Cardiovascular Agents
  • zotarolimus
  • Paclitaxel
  • Sirolimus