Duration of Dual Antiplatelet Therapy after Implantation of Drug-Eluting Stents
- Author(s)
- Seung-Ho Hur; Myung-Ho Jeong; Nae-Hee Lee; Junghan Yoon; Joo-Young Yang; Bong-Ki Lee; Young-Jin Choi; Wook-Sung Chung; Do-Sun Lim; Sang-Sig Cheong; Kee-Sik Kim; Jei Keon Chae; Deuk-Young Nah; Doo-Soo Jeon; Ki Bae Seung; Jae-Sik Jang; Hun Sik Park; Keun Lee; Seung-Jung Park; Duk-Woo Park; Young-Hak Kim; Soo-Jin Kang; Seung-Whan Lee; Cheol Whan Lee; Ki-Hoon Han; Seong-Wook Park; Sung-Cheol Yun; Sang-Gon Lee; Seung-Woon Rha; In-Whan Seong
- Keimyung Author(s)
- Hur, Seung Ho
- Department
- Dept. of Internal Medicine (내과학)
- Journal Title
- New England Journal of Medicine
- Issued Date
- 2010
- Volume
- 362
- Issue
- 15
- Abstract
- 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
In two trials, we randomly assigned a total of 2701 patients who had received 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 19.2 months. 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 differ significantly 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
to 3.45; 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-term follow-up. (ClinicalTrials.gov numbers,
NCT00484926 and NCT00590174.)
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