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original article

Duration of Dual Antiplatelet Therapy after Implantation of Drug-Eluting Stents
Seung-Jung Park, M.D., Duk-Woo Park, M.D., Young-Hak Kim, M.D., Soo-Jin Kang, M.D., Seung-Whan Lee, M.D., Cheol Whan Lee, M.D., Ki-Hoon Han, M.D., Seong-Wook Park, M.D., Sung-Cheol Yun, Ph.D., Sang-Gon Lee, M.D., Seung-Woon Rha,M.D., In-Whan Seong, M.D., Myung-Ho Jeong, M.D., Seung-Ho Hur, M.D., Nae-Hee Lee, M.D., Junghan Yoon, M.D., Joo-Young Yang, M.D., Bong-Ki Lee, M.D., Young-Jin Choi, M.D., Wook-Sung Chung, M.D., Do-Sun Lim, M.D., Sang-Sig Cheong, M.D., Kee-Sik Kim, M.D., Jei Keon Chae, M.D., Deuk-Young Nah, M.D., Doo-Soo Jeon, M.D., Ki Bae Seung, M.D., Jae-Sik Jang, M.D., Hun Sik Park, M.D., and Keun Lee, M.D.*

A BST R AC T
Background

The potential benefits and risks of the use of dual antiplatelet therapy beyond a 12-month period in patients receiving drug-eluting stents have not been clearly established.
Methods

Address reprint requests to Dr. SeungJung Park at the Department of Cardiology, University of Ulsan College of Medicine, Cardiac Center, Asan Medical Center, 3881 Poongnap-dong, Songpa-gu,Seoul, 138736, Korea, or at sjpark@amc.seoul.kr. *The authors’ affiliations are listed in the Appendix. Drs. S.-J. Park and D.-W. Park contributed equally to this article. This article (10.1056/NEJMoa1001266) was published on March 15, 2010, at NEJM .org. N Engl J Med 2010.
Copyright © 2010 Massachusetts Medical Society.

In two trials, we randomly assigned a total of 2701 patients who hadreceived drugeluting stents and had been free of major adverse cardiac or cerebrovascular events and major bleeding for a period of at least 12 months to receive clopidogrel plus aspirin or aspirin alone. The primary end point was a composite of myocardial infarction or death from cardiac causes. Data from the two trials were merged for analysis.
Results

The median duration of follow-up was 19.2months. The cumulative risk of the primary outcome at 2 years was 1.8% with dual antiplatelet therapy, as compared with 1.2% with aspirin monotherapy (hazard ratio, 1.65; 95% confidence interval [CI], 0.80 to 3.36; P = 0.17). The individual risks of myocardial infarction, stroke, stent thrombosis, need for repeat revascularization, major bleeding, and death from any cause did not differsignificantly between the two groups. However, in the dual-therapy group as compared with the aspirin-alone group, there was a nonsignificant increase in the composite risk of myocardial infarction, stroke, or death from any cause (hazard ratio, 1.73; 95% CI, 0.99 to 3.00; P = 0.051) and in the composite risk of myocardial infarction, stroke, or death from cardiac causes (hazard ratio, 1.84; 95% CI, 0.99 to3.45; P = 0.06).
CONCLUSIONS

The use of dual antiplatelet therapy for a period longer than 12 months in patients who had received drug-eluting stents was not significantly more effective than aspirin monotherapy in reducing the rate of myocardial infarction or death from cardiac causes. These findings should be confirmed or refuted through larger, randomized clinical trials with longer-termfollow-up. (ClinicalTrials.gov numbers, NCT00484926 and NCT00590174.)
10.1056/nejmoa1001266 nejm.org

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Downloaded from www.nejm.org on March 15, 2010 . For personal use only. No other uses without permission. Copyright © 2010 Massachusetts Medical Society. All rights reserved.

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everal pivotal clinical trials have shown thatthe use of drug-eluting coronary stents is associated with significant reductions in the risks of restenosis and need for target-lesion revascularization, as compared with use of bare-metal coronary stents.1 On the basis of the results of these trials, drug-eluting stents have been widely used for percutaneous coronary intervention (PCI) in clinical practice.2 However, some longer-term studies...