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J Am Coll Cardiol, 2008; 52:1134-1140, doi:10.1016/j.jacc.2008.07.006
© 2008 by the American College of Cardiology Foundation
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CLINICAL RESEARCH: INTERVENTIONAL CARDIOLOGY

Incidence and Correlates of Drug-Eluting Stent Thrombosis in Routine Clinical Practice

4-Year Results From a Large 2-Institutional Cohort Study

Peter Wenaweser, MD*, Joost Daemen, MD{ddagger}, Marcel Zwahlen, PhD{dagger}, Ron van Domburg, PhD{ddagger}, Peter Jüni, MD{dagger}, Sophia Vaina, MD, PhD{ddagger}, Gerrit Hellige, MD*, Keiichi Tsuchida, MD{ddagger}, Cyrill Morger, MD*, Eric Boersma, PhD{ddagger}, Neville Kukreja, MBBS, MRCP{ddagger}, Bernhard Meier, MD*, Patrick W. Serruys, MD, PhD{ddagger} and Stephan Windecker, MD*,*

* Department of Cardiology, University of Bern, Bern, Switzerland
{dagger} Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland
{ddagger} Department of Interventional Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands

Manuscript received March 18, 2008; revised manuscript received June 30, 2008, accepted July 1, 2008.

* Reprint requests and correspondence: Dr. Stephan Windecker, Department of Cardiology, University Hospital Bern, 3010 Bern, Switzerland (Email: stephan.windecker{at}insel.ch).

Objectives: We sought to determine the risk of late stent thrombosis (ST) during long-term follow-up beyond 3 years, searched for predictors, and assessed the impact of ST on overall mortality.

Background: Late ST was reported to occur at an annual rate of 0.6% up to 3 years after drug-eluting stent (DES) implantation.

Methods: A total of 8,146 patients underwent percutaneous coronary intervention with a sirolimus-eluting stent (SES) (n = 3,823) or paclitaxel-eluting stent (PES) (n = 4,323) and were followed up to 4 years after stent implantation. Dual antiplatelet treatment was prescribed for 6 to 12 months.

Results: Definite ST occurred in 192 of 8,146 patients with an incidence density of 1.0/100 patient-years and a cumulative incidence of 3.3% at 4 years. The hazard of ST continued at a steady rate of 0.53% (95% confidence interval [CI]: 0.44 to 0.64) between 30 days and 4 years. Diabetes was an independent predictor of early ST (hazard ratio [HR]: 1.96; 95% CI: 1.18 to 3.28), and acute coronary syndrome (HR: 2.21; 95% CI: 1.39 to 3.51), younger age (HR: 0.97; 95% CI: 0.95 to 0.99), and use of PES (HR: 1.67; 95% CI: 1.08 to 2.56) were independent predictors of late ST. Rates of death and myocardial infarction at 4 years were 10.6% and 4.6%, respectively.

Conclusions: Late ST occurs steadily at an annual rate of 0.4% to 0.6% for up to 4 years. Diabetes is an independent predictor of early ST, whereas acute coronary syndrome, younger age, and PES implantation are associated with late ST.

Key Words: drug-eluting stent • mortality • stent thrombosis

Abbreviations and Acronyms
  ACS = acute coronary syndrome
  ARC = Academic Research Consortium
  ASA = acetylsalicylic acid
  BMS = bare-metal stent(s)
  CI = confidence interval
  DES = drug-eluting stent(s)
  MACE = major adverse cardiac event
  MI = myocardial infarction
  PES = paclitaxel-eluting stent(s)
  SES = sirolimus-eluting stent(s)
  ST = stent thrombosis
  TIMI = Thrombolysis In Myocardial Infarction




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