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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, Marcel Zwahlen, PhD, Ron van Domburg, PhD, Peter Jüni, MD, Sophia Vaina, MD, PhD, Gerrit Hellige, MD^_*, Keiichi Tsuchida, MD, Cyrill Morger, MD^_*, Eric Boersma, PhD, Neville Kukreja, MBBS, MRCP, Bernhard Meier, MD^_*, Patrick W. Serruys, MD, PhD and Stephan Windecker, MD^_*,_*

^_* Department of Cardiology, University of Bern, Bern, Switzerland
Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland
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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