Duration of dual antiplatelet therapy after implantation of drug-eluting stents

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 ChungDo 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

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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 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.)

Original languageEnglish
Pages (from-to)1374-1382
Number of pages9
JournalNew England Journal of Medicine
Volume362
Issue number15
DOIs
Publication statusPublished - 2010 Apr 15

All Science Journal Classification (ASJC) codes

  • Medicine(all)

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    Park, S. J., Park, D. W., Kim, Y. H., Kang, S. J., Lee, S. W., Lee, C. W., Han, K. H., Park, S. W., Yun, S. C., Lee, S. G., Rha, S. W., Seong, I. W., Jeong, M. H., Hur, S. H., Lee, N. H., Yoon, J., Yang, J. Y., Lee, B. K., Choi, Y. J., ... Lee, K. (2010). Duration of dual antiplatelet therapy after implantation of drug-eluting stents. New England Journal of Medicine, 362(15), 1374-1382. https://doi.org/10.1056/NEJMoa1001266