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 Chung & 10 others 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

Research output: Contribution to journalArticle

402 Citations (Scopus)

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

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Drug-Eluting Stents
Aspirin
Cause of Death
Myocardial Infarction
clopidogrel
Stroke
Confidence Intervals
Hemorrhage
Therapeutics
Group Psychotherapy
Stents
Thrombosis
Randomized Controlled Trials

All Science Journal Classification (ASJC) codes

  • Medicine(all)

Cite this

Park, S. J., Park, D. W., Kim, Y. H., Kang, S. J., Lee, S. W., Lee, C. W., ... 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
Park, Seung Jung ; Park, Duk Woo ; Kim, Young Hak ; Kang, Soo Jin ; Lee, Seung Whan ; Lee, Cheol Whan ; Han, Ki Hoon ; Park, Seong Wook ; Yun, Sung Cheol ; Lee, Sang Gon ; Rha, Seung Woon ; Seong, In Whan ; Jeong, Myung Ho ; Hur, Seung Ho ; Lee, Nae Hee ; Yoon, Junghan ; Yang, Joo Young ; Lee, Bong Ki ; Choi, Young Jin ; Chung, Wook Sung ; Lim, Do Sun ; Cheong, Sang Sig ; Kim, Kee Sik ; Chae, Jei Keon ; Nah, Deuk Young ; Jeon, Doo Soo ; Seung, Ki Bae ; Jang, Jae Sik ; Park, Hun Sik ; Lee, Keun. / Duration of dual antiplatelet therapy after implantation of drug-eluting stents. In: New England Journal of Medicine. 2010 ; Vol. 362, No. 15. pp. 1374-1382.
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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.)",
author = "Park, {Seung Jung} and Park, {Duk Woo} and Kim, {Young Hak} and Kang, {Soo Jin} and Lee, {Seung Whan} and Lee, {Cheol Whan} and Han, {Ki Hoon} and Park, {Seong Wook} and Yun, {Sung Cheol} and Lee, {Sang Gon} and Rha, {Seung Woon} and Seong, {In Whan} and Jeong, {Myung Ho} and Hur, {Seung Ho} and Lee, {Nae Hee} and Junghan Yoon and Yang, {Joo Young} and Lee, {Bong Ki} and Choi, {Young Jin} and Chung, {Wook Sung} and Lim, {Do Sun} and Cheong, {Sang Sig} and Kim, {Kee Sik} and Chae, {Jei Keon} and Nah, {Deuk Young} and Jeon, {Doo Soo} and Seung, {Ki Bae} and Jang, {Jae Sik} and Park, {Hun Sik} and Keun Lee",
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Park, SJ, Park, DW, Kim, YH, Kang, SJ, Lee, SW, Lee, CW, Han, KH, Park, SW, Yun, SC, Lee, SG, Rha, SW, Seong, IW, Jeong, MH, Hur, SH, Lee, NH, Yoon, J, Yang, JY, Lee, BK, Choi, YJ, Chung, WS, Lim, DS, Cheong, SS, Kim, KS, Chae, JK, Nah, DY, Jeon, DS, Seung, KB, Jang, JS, Park, HS & Lee, K 2010, 'Duration of dual antiplatelet therapy after implantation of drug-eluting stents', New England Journal of Medicine, vol. 362, no. 15, pp. 1374-1382. https://doi.org/10.1056/NEJMoa1001266

Duration of dual antiplatelet therapy after implantation of drug-eluting stents. / Park, Seung Jung; Park, Duk Woo; Kim, Young Hak; Kang, Soo Jin; Lee, Seung Whan; Lee, Cheol Whan; Han, Ki Hoon; Park, Seong Wook; Yun, Sung Cheol; Lee, Sang Gon; Rha, Seung Woon; Seong, In Whan; Jeong, Myung Ho; Hur, Seung Ho; Lee, Nae Hee; Yoon, Junghan; Yang, Joo Young; Lee, Bong Ki; Choi, Young Jin; Chung, Wook Sung; Lim, Do Sun; Cheong, Sang Sig; Kim, Kee Sik; Chae, Jei Keon; Nah, Deuk Young; Jeon, Doo Soo; Seung, Ki Bae; Jang, Jae Sik; Park, Hun Sik; Lee, Keun.

In: New England Journal of Medicine, Vol. 362, No. 15, 15.04.2010, p. 1374-1382.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Duration of dual antiplatelet therapy after implantation of drug-eluting stents

AU - Park, Seung Jung

AU - Park, Duk Woo

AU - Kim, Young Hak

AU - Kang, Soo Jin

AU - Lee, Seung Whan

AU - Lee, Cheol Whan

AU - Han, Ki Hoon

AU - Park, Seong Wook

AU - Yun, Sung Cheol

AU - Lee, Sang Gon

AU - Rha, Seung Woon

AU - Seong, In Whan

AU - Jeong, Myung Ho

AU - Hur, Seung Ho

AU - Lee, Nae Hee

AU - Yoon, Junghan

AU - Yang, Joo Young

AU - Lee, Bong Ki

AU - Choi, Young Jin

AU - Chung, Wook Sung

AU - Lim, Do Sun

AU - Cheong, Sang Sig

AU - Kim, Kee Sik

AU - Chae, Jei Keon

AU - Nah, Deuk Young

AU - Jeon, Doo Soo

AU - Seung, Ki Bae

AU - Jang, Jae Sik

AU - Park, Hun Sik

AU - Lee, Keun

PY - 2010/4/15

Y1 - 2010/4/15

N2 - 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.)

AB - 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.)

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DO - 10.1056/NEJMoa1001266

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JO - New England Journal of Medicine

JF - New England Journal of Medicine

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