Document Detail


Duration of dual antiplatelet therapy after implantation of drug-eluting stents.
MedLine Citation:
PMID:  20231231     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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 drug-eluting 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.)
Authors:
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; Myung-Ho Jeong; Seung-Ho Hur; 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
Publication Detail:
Type:  Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2010-03-15
Journal Detail:
Title:  The New England journal of medicine     Volume:  362     ISSN:  1533-4406     ISO Abbreviation:  N. Engl. J. Med.     Publication Date:  2010 Apr 
Date Detail:
Created Date:  2010-04-15     Completed Date:  2010-04-22     Revised Date:  2010-09-09    
Medline Journal Info:
Nlm Unique ID:  0255562     Medline TA:  N Engl J Med     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1374-82     Citation Subset:  AIM; IM    
Copyright Information:
2010 Massachusetts Medical Society
Affiliation:
Department of Cardiology, Center for Medical Research and Information, University of Ulsan College of Medicine, Seoul, South Korea.
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00484926;  NCT00590174
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MeSH Terms
Descriptor/Qualifier:
Aged
Angioplasty, Transluminal, Percutaneous Coronary
Aspirin / administration & dosage*
Coronary Disease / mortality,  therapy*
Drug Administration Schedule
Drug Therapy, Combination
Drug-Eluting Stents*
Female
Follow-Up Studies
Humans
Kaplan-Meiers Estimate
Male
Middle Aged
Myocardial Infarction / epidemiology
Platelet Aggregation Inhibitors / administration & dosage*,  adverse effects
Proportional Hazards Models
Retreatment
Stroke / epidemiology
Thrombosis / prevention & control
Ticlopidine / administration & dosage,  adverse effects,  analogs & derivatives*
Chemical
Reg. No./Substance:
0/Platelet Aggregation Inhibitors; 50-78-2/Aspirin; 55142-85-3/Ticlopidine; 90055-48-4/clopidogrel
Comments/Corrections
Comment In:
N Engl J Med. 2010 Apr 15;362(15):1441-3   [PMID:  20231230 ]
Curr Cardiol Rep. 2010 Sep;12(5):357-60   [PMID:  20544309 ]
N Engl J Med. 2010 Jul 29;363(5):489; author reply 490
N Engl J Med. 2010 Jul 29;363(5):488-9; author reply 490
N Engl J Med. 2010 Jul 29;363(5):489-90; author reply 490
N Engl J Med. 2010 Jul 29;363(5):488; author reply 490   [PMID:  20666628 ]

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