Six-month versus 12-month dual antiplatelet therapy after implantation of drug-eluting stents: The efficacy of xience/promus versus cypher to reduce late loss after stenting (EXCELLENT) randomized, multicenter study

Hyeon Cheol Gwon; Joo Yong Hahn; Kyung Woo Park; Young Bin Song; In Ho Chae; Do Sun Lim; Kyoo Rok Han; Jin Ho Choi; Seung Hyuk Choi; Hyun Jae Kang; Bon Kwon Koo; Taehoon Ahn; Jung Han Yoon; Myung Ho Jeong; Taek Jong Hong; Woo Young Chung; Young Jin Choi; Seung Ho Hur; Hyuck Moon Kwon; Dong Woon Jeon; Byung Ok Kim; Si Hoon Park; Nam Ho Lee; Hui Kyung Jeon; Yangsoo Jang; Hyo Soo Kim

doi:10.1161/CIRCULATIONAHA.111.059022

Six-month versus 12-month dual antiplatelet therapy after implantation of drug-eluting stents: The efficacy of xience/promus versus cypher to reduce late loss after stenting (EXCELLENT) randomized, multicenter study

Hyeon Cheol Gwon, Joo Yong Hahn, Kyung Woo Park, Young Bin Song, In Ho Chae, Do Sun Lim, Kyoo Rok Han, Jin Ho Choi, Seung Hyuk Choi, Hyun Jae Kang, Bon Kwon Koo, Taehoon Ahn, Jung Han Yoon, Myung Ho Jeong, Taek Jong Hong, Woo Young Chung, Young Jin Choi, Seung Ho Hur, Hyuck Moon Kwon, Dong Woon JeonByung Ok Kim, Si Hoon Park, Nam Ho Lee, Hui Kyung Jeon, Yangsoo Jang, Hyo Soo Kim

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Abstract

BACKGROUND-: The optimal duration of dual antiplatelet therapy (DAPT) after implantation of drug-eluting coronary stents remains undetermined. We aimed to test whether 6-month DAPT would be noninferior to 12-month DAPT after implantation of drug-eluting stents. METHODS AND RESULTS-: We randomly assigned 1443 patients undergoing implantation of drug-eluting stents to receive 6- or 12-month DAPT (in a 1:1 ratio). The primary end point was a target vessel failure, defined as the composite of cardiac death, myocardial infarction, or ischemia-driven target vessel revascularization at 12 months. Rates of target vessel failure at 12 months were 4.8% in the 6-month DAPT group and 4.3% in the 12-month DAPT group (the upper limit of 1-sided 95% confidence interval, 2.4%; P=0.001 for noninferiority with a predefined noninferiority margin of 4.0%). Although stent thrombosis tended to occur more frequently in the 6-month DAPT group than in the 12-month group (0.9% versus 0.1%; hazard ratio, 6.02; 95% confidence interval, 0.72-49.96; P=0.10), the risk of death or myocardial infarction did not differ in the 2 groups (2.4% versus 1.9%; hazard ratio, 1.21; 95% confidence interval, 0.60-2.47; P=0.58). In the prespecified subgroup analysis, target vessel failure occurred more frequently in the 6-month DAPT group than in the 12-month group (hazard ratio, 3.16; 95% confidence interval, 1.42-7.03; P=0.005) among diabetic patients. CONCLUSIONS-: Six-month DAPT did not increase the risk of target vessel failure at 12 months after implantation of drug-eluting stents compared with 12-month DAPT. However, the noninferiority margin was wide, and the study was underpowered for death or myocardial infarction. Our results need to be confirmed in larger trials. CLINICAL TRIAL REGISTRATION-: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00698607.

Original language	English
Pages (from-to)	505-513
Number of pages	9
Journal	Circulation
Volume	125
Issue number	3
DOIs	https://doi.org/10.1161/CIRCULATIONAHA.111.059022
Publication status	Published - 2012 Jan 24

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Cardiology and Cardiovascular Medicine
Physiology (medical)

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Gwon, H. C., Hahn, J. Y., Park, K. W., Song, Y. B., Chae, I. H., Lim, D. S., Han, K. R., Choi, J. H., Choi, S. H., Kang, H. J., Koo, B. K., Ahn, T., Yoon, J. H., Jeong, M. H., Hong, T. J., Chung, W. Y., Choi, Y. J., Hur, S. H., Kwon, H. M., ... Kim, H. S. (2012). Six-month versus 12-month dual antiplatelet therapy after implantation of drug-eluting stents: The efficacy of xience/promus versus cypher to reduce late loss after stenting (EXCELLENT) randomized, multicenter study. Circulation, 125(3), 505-513. https://doi.org/10.1161/CIRCULATIONAHA.111.059022

@article{009091509c724ea484510bf0461d0ce8,

title = "Six-month versus 12-month dual antiplatelet therapy after implantation of drug-eluting stents: The efficacy of xience/promus versus cypher to reduce late loss after stenting (EXCELLENT) randomized, multicenter study",

abstract = "BACKGROUND-: The optimal duration of dual antiplatelet therapy (DAPT) after implantation of drug-eluting coronary stents remains undetermined. We aimed to test whether 6-month DAPT would be noninferior to 12-month DAPT after implantation of drug-eluting stents. METHODS AND RESULTS-: We randomly assigned 1443 patients undergoing implantation of drug-eluting stents to receive 6- or 12-month DAPT (in a 1:1 ratio). The primary end point was a target vessel failure, defined as the composite of cardiac death, myocardial infarction, or ischemia-driven target vessel revascularization at 12 months. Rates of target vessel failure at 12 months were 4.8% in the 6-month DAPT group and 4.3% in the 12-month DAPT group (the upper limit of 1-sided 95% confidence interval, 2.4%; P=0.001 for noninferiority with a predefined noninferiority margin of 4.0%). Although stent thrombosis tended to occur more frequently in the 6-month DAPT group than in the 12-month group (0.9% versus 0.1%; hazard ratio, 6.02; 95% confidence interval, 0.72-49.96; P=0.10), the risk of death or myocardial infarction did not differ in the 2 groups (2.4% versus 1.9%; hazard ratio, 1.21; 95% confidence interval, 0.60-2.47; P=0.58). In the prespecified subgroup analysis, target vessel failure occurred more frequently in the 6-month DAPT group than in the 12-month group (hazard ratio, 3.16; 95% confidence interval, 1.42-7.03; P=0.005) among diabetic patients. CONCLUSIONS-: Six-month DAPT did not increase the risk of target vessel failure at 12 months after implantation of drug-eluting stents compared with 12-month DAPT. However, the noninferiority margin was wide, and the study was underpowered for death or myocardial infarction. Our results need to be confirmed in larger trials. CLINICAL TRIAL REGISTRATION-: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00698607.",

author = "Gwon, {Hyeon Cheol} and Hahn, {Joo Yong} and Park, {Kyung Woo} and Song, {Young Bin} and Chae, {In Ho} and Lim, {Do Sun} and Han, {Kyoo Rok} and Choi, {Jin Ho} and Choi, {Seung Hyuk} and Kang, {Hyun Jae} and Koo, {Bon Kwon} and Taehoon Ahn and Yoon, {Jung Han} and Jeong, {Myung Ho} and Hong, {Taek Jong} and Chung, {Woo Young} and Choi, {Young Jin} and Hur, {Seung Ho} and Kwon, {Hyuck Moon} and Jeon, {Dong Woon} and Kim, {Byung Ok} and Park, {Si Hoon} and Lee, {Nam Ho} and Jeon, {Hui Kyung} and Yangsoo Jang and Kim, {Hyo Soo}",

year = "2012",

month = jan,

day = "24",

doi = "10.1161/CIRCULATIONAHA.111.059022",

language = "English",

volume = "125",

pages = "505--513",

journal = "Circulation",

issn = "0009-7322",

publisher = "Lippincott Williams and Wilkins",

number = "3",

}

Gwon, HC, Hahn, JY, Park, KW, Song, YB, Chae, IH, Lim, DS, Han, KR, Choi, JH, Choi, SH, Kang, HJ, Koo, BK, Ahn, T, Yoon, JH, Jeong, MH, Hong, TJ, Chung, WY, Choi, YJ, Hur, SH, Kwon, HM, Jeon, DW, Kim, BO, Park, SH, Lee, NH, Jeon, HK, Jang, Y & Kim, HS 2012, 'Six-month versus 12-month dual antiplatelet therapy after implantation of drug-eluting stents: The efficacy of xience/promus versus cypher to reduce late loss after stenting (EXCELLENT) randomized, multicenter study', Circulation, vol. 125, no. 3, pp. 505-513. https://doi.org/10.1161/CIRCULATIONAHA.111.059022

Six-month versus 12-month dual antiplatelet therapy after implantation of drug-eluting stents: The efficacy of xience/promus versus cypher to reduce late loss after stenting (EXCELLENT) randomized, multicenter study. / Gwon, Hyeon Cheol; Hahn, Joo Yong; Park, Kyung Woo et al.
In: Circulation, Vol. 125, No. 3, 24.01.2012, p. 505-513.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - Six-month versus 12-month dual antiplatelet therapy after implantation of drug-eluting stents

T2 - The efficacy of xience/promus versus cypher to reduce late loss after stenting (EXCELLENT) randomized, multicenter study

AU - Gwon, Hyeon Cheol

AU - Hahn, Joo Yong

AU - Park, Kyung Woo

AU - Song, Young Bin

AU - Chae, In Ho

AU - Lim, Do Sun

AU - Han, Kyoo Rok

AU - Choi, Jin Ho

AU - Choi, Seung Hyuk

AU - Kang, Hyun Jae

AU - Koo, Bon Kwon

AU - Ahn, Taehoon

AU - Yoon, Jung Han

AU - Jeong, Myung Ho

AU - Hong, Taek Jong

AU - Chung, Woo Young

AU - Choi, Young Jin

AU - Hur, Seung Ho

AU - Kwon, Hyuck Moon

AU - Jeon, Dong Woon

AU - Kim, Byung Ok

AU - Park, Si Hoon

AU - Lee, Nam Ho

AU - Jeon, Hui Kyung

AU - Jang, Yangsoo

AU - Kim, Hyo Soo

PY - 2012/1/24

Y1 - 2012/1/24

N2 - BACKGROUND-: The optimal duration of dual antiplatelet therapy (DAPT) after implantation of drug-eluting coronary stents remains undetermined. We aimed to test whether 6-month DAPT would be noninferior to 12-month DAPT after implantation of drug-eluting stents. METHODS AND RESULTS-: We randomly assigned 1443 patients undergoing implantation of drug-eluting stents to receive 6- or 12-month DAPT (in a 1:1 ratio). The primary end point was a target vessel failure, defined as the composite of cardiac death, myocardial infarction, or ischemia-driven target vessel revascularization at 12 months. Rates of target vessel failure at 12 months were 4.8% in the 6-month DAPT group and 4.3% in the 12-month DAPT group (the upper limit of 1-sided 95% confidence interval, 2.4%; P=0.001 for noninferiority with a predefined noninferiority margin of 4.0%). Although stent thrombosis tended to occur more frequently in the 6-month DAPT group than in the 12-month group (0.9% versus 0.1%; hazard ratio, 6.02; 95% confidence interval, 0.72-49.96; P=0.10), the risk of death or myocardial infarction did not differ in the 2 groups (2.4% versus 1.9%; hazard ratio, 1.21; 95% confidence interval, 0.60-2.47; P=0.58). In the prespecified subgroup analysis, target vessel failure occurred more frequently in the 6-month DAPT group than in the 12-month group (hazard ratio, 3.16; 95% confidence interval, 1.42-7.03; P=0.005) among diabetic patients. CONCLUSIONS-: Six-month DAPT did not increase the risk of target vessel failure at 12 months after implantation of drug-eluting stents compared with 12-month DAPT. However, the noninferiority margin was wide, and the study was underpowered for death or myocardial infarction. Our results need to be confirmed in larger trials. CLINICAL TRIAL REGISTRATION-: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00698607.

AB - BACKGROUND-: The optimal duration of dual antiplatelet therapy (DAPT) after implantation of drug-eluting coronary stents remains undetermined. We aimed to test whether 6-month DAPT would be noninferior to 12-month DAPT after implantation of drug-eluting stents. METHODS AND RESULTS-: We randomly assigned 1443 patients undergoing implantation of drug-eluting stents to receive 6- or 12-month DAPT (in a 1:1 ratio). The primary end point was a target vessel failure, defined as the composite of cardiac death, myocardial infarction, or ischemia-driven target vessel revascularization at 12 months. Rates of target vessel failure at 12 months were 4.8% in the 6-month DAPT group and 4.3% in the 12-month DAPT group (the upper limit of 1-sided 95% confidence interval, 2.4%; P=0.001 for noninferiority with a predefined noninferiority margin of 4.0%). Although stent thrombosis tended to occur more frequently in the 6-month DAPT group than in the 12-month group (0.9% versus 0.1%; hazard ratio, 6.02; 95% confidence interval, 0.72-49.96; P=0.10), the risk of death or myocardial infarction did not differ in the 2 groups (2.4% versus 1.9%; hazard ratio, 1.21; 95% confidence interval, 0.60-2.47; P=0.58). In the prespecified subgroup analysis, target vessel failure occurred more frequently in the 6-month DAPT group than in the 12-month group (hazard ratio, 3.16; 95% confidence interval, 1.42-7.03; P=0.005) among diabetic patients. CONCLUSIONS-: Six-month DAPT did not increase the risk of target vessel failure at 12 months after implantation of drug-eluting stents compared with 12-month DAPT. However, the noninferiority margin was wide, and the study was underpowered for death or myocardial infarction. Our results need to be confirmed in larger trials. CLINICAL TRIAL REGISTRATION-: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00698607.

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U2 - 10.1161/CIRCULATIONAHA.111.059022

DO - 10.1161/CIRCULATIONAHA.111.059022

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AN - SCOPUS:84856452781

SN - 0009-7322

VL - 125

SP - 505

EP - 513

JO - Circulation

JF - Circulation

IS - 3

ER -

Six-month versus 12-month dual antiplatelet therapy after implantation of drug-eluting stents: The efficacy of xience/promus versus cypher to reduce late loss after stenting (EXCELLENT) randomized, multicenter study

Abstract

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