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Stent Thrombosis, Clinical Events, and Influence of Prolonged Clopidogrel Use After Placement of Drug-Eluting Stent

Data From an Observational Cohort Study of Drug-Eluting Versus Bare-Metal Stents

Duk-Woo Park, MD^_*, Sung-Cheol Yun, PhD, Seung-Whan Lee, MD^_*, Young-Hak Kim, MD^_*, Cheol Whan Lee, MD^_*, Myeong-Ki Hong, MD^_*, Sang-Sig Cheong, MD, Jae-Joong Kim, MD^_*, Seong-Wook Park, MD^_*, Seung-Jung Park, MD^_*,_*

^_* Department of Cardiology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea
Department of Cardiology, Asan Medical Center, GangNeung, Korea
Division of Biostatistics, Center for Medical Research and Information, University of Ulsan College of Medicine, Seoul, Korea

^_* Reprint requests and correspondence: Dr. Seung-Jung Park, Department of Cardiology, University of Ulsan College of Medicine, Asan Medical Center, 388-1 Poongnap-dong, Songpa-gu, Seoul, 138-736, Korea (Email: sjpark{at}amc.seoul.kr).

Objectives: The purpose of this study was to evaluate the risk of stent thrombosis (ST), clinical outcomes, and the benefits of extended clopidogrel use after drug-eluting stent (DES) implantation.

Background: Data are limited regarding uniform evaluation of ST and the influence of clopidogrel continuation beyond 12 months on late events after DES treatment.

Methods: We identified 7,221 patients who received DES implantation (n = 3,160) or bare-metal stent (BMS) implantation (n = 4,061), and compared long-term adverse outcomes. Additionally, 2,851 patients with DES surviving 12 months without major events were analyzed according to clopidogrel continuation.

Results: The adjusted-risk of overall ST was similar in the 2 groups. After 1 year, however, DES patients showed a higher risk of ST; definite/probable (hazard ratio [HR]: 3.55, 95% confidence interval [CI]: 1.26 to 9.99). The adjusted-risk of death (HR: 0.60, 95% CI: 0.46 to 0.79), death/myocardial infarction (HR: 0.63, 95% CI: 0.49 to 0.81), and target lesion revascularization (HR: 0.32, 95% CI: 0.24 to 0.43) were significantly lower in the DES group than in the BMS group. Continuing clopidogrel beyond 12 months was not associated with a reduced risk for ST (HR: 0.54, 95% CI: 0.07 to 4.23), death (HR: 1.20, 95% CI: 0.55 to 2.66), or death/myocardial infarction (HR: 1.16, 95% CI: 0.56 to 2.42) after DES implantation.

Conclusions: As compared with BMS, DES showed a similar risk of overall ST, but a higher risk of very late ST. The rates of death, death/myocardial infarction, and target lesion revasuclarization were significantly lower in the DES group. Clopidogrel continuation beyond 1 year did not appear to reduce ST and clinical events after DES implantation.

Key Words: coronary disease • stents • thrombosis

Abbreviations and Acronyms   ARC = Academic Research Consortium   BMS = bare-metal stent(s)   CI = confidence interval   DES = drug-eluting stent(s)   HR = hazard ratio   MI = myocardial infarction   PCI = percutaneous coronary intervention   ST = stent thrombosis