A new strategy for discontinuation of dual antiplatelet therapy

The reset trial (real safety and efficacy of 3-month dual antiplatelet therapy following endeavor zotarolimus-eluting stent implantation)

Byeong Keuk Kim, Myeongki Hong, Dong Ho Shin, Chung Mo Nam, Jung Sun Kim, Young Guk Ko, Donghoon Choi, Tae Soo Kang, Byoung Eun Park, Woong Chol Kang, Seunghwan Lee, Junghan Yoon, Bum Kee Hong, Hyuck Moon Kwon, Yangsoo Jang

Research output: Contribution to journalArticle

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Abstract

Objectives: The goal of this study was to evaluate shorter duration (3 months) dual antiplatelet therapy (DAPT) after drug-eluting stent (DES) implantation. Background: There have been few published reports of prospective randomized clinical studies comparing the safety and efficacy of shorter duration DAPT after DES implantation. Methods: We randomly assigned 2,117 patients with coronary artery stenosis into 2 groups according to DAPT duration and stent type: 3-month DAPT following Endeavor zotarolimus-eluting stent (E-ZES) implantation (E-ZES+3-month DAPT, n = 1,059) versus 12-month DAPT following the other DES implantation (standard therapy, n = 1,058). We hypothesized that the E-ZES+3-month DAPT would be noninferior to the standard therapy for the primary composite endpoint (cardiovascular death, myocardial infarction, stent thrombosis, target\vessel revascularization, or bleeding) at 1 year. Results: The primary endpoint occurred in 40 (4.7%) patients assigned to E-ZES+3-month DAPT compared with 41 (4.7%) patients assigned to the standard therapy (difference: 0.0%; 95% confidence interval [CI]: -2.5 to 2.5; p = 0.84; p < 0.001 for noninferiority). The composite rates of any death, myocardial infarction, or stent thrombosis were 0.8% and 1.3%, respectively (difference: -0.5%; 95% CI: -1.5 to 0.5; p = 0.48). The rates of stent thrombosis were 0.2% and 0.3%, respectively (difference: -0.1%; 95% CI: -0.5 to 0.3; p = 0.65) without its further occurrence after cessation of clopidogrel in the E-ZES+3-month DAPT group. The rates of target vessel revascularization were 3.9% and 3.7%, respectively (difference: 0.2%; 95% CI: -2.3 to 2.6; p = 0.70). Conclusions: E-ZES+3-month DAPT was noninferior to the standard therapy with respect to the occurrence of the primary endpoint. (REal Safety and Efficacy of a 3-month dual antiplatelet Therapy following E-ZES implantation [RESET]; NCT01145079)

Original languageEnglish
Pages (from-to)1340-1348
Number of pages9
JournalJournal of the American College of Cardiology
Volume60
Issue number15
DOIs
Publication statusPublished - 2012 Oct 9

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Stents
Safety
Therapeutics
Drug-Eluting Stents
Confidence Intervals
Thrombosis
clopidogrel
zotarolimus
Myocardial Infarction
Coronary Stenosis
Group Psychotherapy
Hemorrhage

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

Cite this

@article{4938863f5152441ab89279ed47523a6f,
title = "A new strategy for discontinuation of dual antiplatelet therapy: The reset trial (real safety and efficacy of 3-month dual antiplatelet therapy following endeavor zotarolimus-eluting stent implantation)",
abstract = "Objectives: The goal of this study was to evaluate shorter duration (3 months) dual antiplatelet therapy (DAPT) after drug-eluting stent (DES) implantation. Background: There have been few published reports of prospective randomized clinical studies comparing the safety and efficacy of shorter duration DAPT after DES implantation. Methods: We randomly assigned 2,117 patients with coronary artery stenosis into 2 groups according to DAPT duration and stent type: 3-month DAPT following Endeavor zotarolimus-eluting stent (E-ZES) implantation (E-ZES+3-month DAPT, n = 1,059) versus 12-month DAPT following the other DES implantation (standard therapy, n = 1,058). We hypothesized that the E-ZES+3-month DAPT would be noninferior to the standard therapy for the primary composite endpoint (cardiovascular death, myocardial infarction, stent thrombosis, target\vessel revascularization, or bleeding) at 1 year. Results: The primary endpoint occurred in 40 (4.7{\%}) patients assigned to E-ZES+3-month DAPT compared with 41 (4.7{\%}) patients assigned to the standard therapy (difference: 0.0{\%}; 95{\%} confidence interval [CI]: -2.5 to 2.5; p = 0.84; p < 0.001 for noninferiority). The composite rates of any death, myocardial infarction, or stent thrombosis were 0.8{\%} and 1.3{\%}, respectively (difference: -0.5{\%}; 95{\%} CI: -1.5 to 0.5; p = 0.48). The rates of stent thrombosis were 0.2{\%} and 0.3{\%}, respectively (difference: -0.1{\%}; 95{\%} CI: -0.5 to 0.3; p = 0.65) without its further occurrence after cessation of clopidogrel in the E-ZES+3-month DAPT group. The rates of target vessel revascularization were 3.9{\%} and 3.7{\%}, respectively (difference: 0.2{\%}; 95{\%} CI: -2.3 to 2.6; p = 0.70). Conclusions: E-ZES+3-month DAPT was noninferior to the standard therapy with respect to the occurrence of the primary endpoint. (REal Safety and Efficacy of a 3-month dual antiplatelet Therapy following E-ZES implantation [RESET]; NCT01145079)",
author = "Kim, {Byeong Keuk} and Myeongki Hong and Shin, {Dong Ho} and Nam, {Chung Mo} and Kim, {Jung Sun} and Ko, {Young Guk} and Donghoon Choi and Kang, {Tae Soo} and Park, {Byoung Eun} and Kang, {Woong Chol} and Seunghwan Lee and Junghan Yoon and Hong, {Bum Kee} and Kwon, {Hyuck Moon} and Yangsoo Jang",
year = "2012",
month = "10",
day = "9",
doi = "10.1016/j.jacc.2012.06.043",
language = "English",
volume = "60",
pages = "1340--1348",
journal = "Journal of the American College of Cardiology",
issn = "0735-1097",
publisher = "Elsevier USA",
number = "15",

}

A new strategy for discontinuation of dual antiplatelet therapy : The reset trial (real safety and efficacy of 3-month dual antiplatelet therapy following endeavor zotarolimus-eluting stent implantation). / Kim, Byeong Keuk; Hong, Myeongki; Shin, Dong Ho; Nam, Chung Mo; Kim, Jung Sun; Ko, Young Guk; Choi, Donghoon; Kang, Tae Soo; Park, Byoung Eun; Kang, Woong Chol; Lee, Seunghwan; Yoon, Junghan; Hong, Bum Kee; Kwon, Hyuck Moon; Jang, Yangsoo.

In: Journal of the American College of Cardiology, Vol. 60, No. 15, 09.10.2012, p. 1340-1348.

Research output: Contribution to journalArticle

TY - JOUR

T1 - A new strategy for discontinuation of dual antiplatelet therapy

T2 - The reset trial (real safety and efficacy of 3-month dual antiplatelet therapy following endeavor zotarolimus-eluting stent implantation)

AU - Kim, Byeong Keuk

AU - Hong, Myeongki

AU - Shin, Dong Ho

AU - Nam, Chung Mo

AU - Kim, Jung Sun

AU - Ko, Young Guk

AU - Choi, Donghoon

AU - Kang, Tae Soo

AU - Park, Byoung Eun

AU - Kang, Woong Chol

AU - Lee, Seunghwan

AU - Yoon, Junghan

AU - Hong, Bum Kee

AU - Kwon, Hyuck Moon

AU - Jang, Yangsoo

PY - 2012/10/9

Y1 - 2012/10/9

N2 - Objectives: The goal of this study was to evaluate shorter duration (3 months) dual antiplatelet therapy (DAPT) after drug-eluting stent (DES) implantation. Background: There have been few published reports of prospective randomized clinical studies comparing the safety and efficacy of shorter duration DAPT after DES implantation. Methods: We randomly assigned 2,117 patients with coronary artery stenosis into 2 groups according to DAPT duration and stent type: 3-month DAPT following Endeavor zotarolimus-eluting stent (E-ZES) implantation (E-ZES+3-month DAPT, n = 1,059) versus 12-month DAPT following the other DES implantation (standard therapy, n = 1,058). We hypothesized that the E-ZES+3-month DAPT would be noninferior to the standard therapy for the primary composite endpoint (cardiovascular death, myocardial infarction, stent thrombosis, target\vessel revascularization, or bleeding) at 1 year. Results: The primary endpoint occurred in 40 (4.7%) patients assigned to E-ZES+3-month DAPT compared with 41 (4.7%) patients assigned to the standard therapy (difference: 0.0%; 95% confidence interval [CI]: -2.5 to 2.5; p = 0.84; p < 0.001 for noninferiority). The composite rates of any death, myocardial infarction, or stent thrombosis were 0.8% and 1.3%, respectively (difference: -0.5%; 95% CI: -1.5 to 0.5; p = 0.48). The rates of stent thrombosis were 0.2% and 0.3%, respectively (difference: -0.1%; 95% CI: -0.5 to 0.3; p = 0.65) without its further occurrence after cessation of clopidogrel in the E-ZES+3-month DAPT group. The rates of target vessel revascularization were 3.9% and 3.7%, respectively (difference: 0.2%; 95% CI: -2.3 to 2.6; p = 0.70). Conclusions: E-ZES+3-month DAPT was noninferior to the standard therapy with respect to the occurrence of the primary endpoint. (REal Safety and Efficacy of a 3-month dual antiplatelet Therapy following E-ZES implantation [RESET]; NCT01145079)

AB - Objectives: The goal of this study was to evaluate shorter duration (3 months) dual antiplatelet therapy (DAPT) after drug-eluting stent (DES) implantation. Background: There have been few published reports of prospective randomized clinical studies comparing the safety and efficacy of shorter duration DAPT after DES implantation. Methods: We randomly assigned 2,117 patients with coronary artery stenosis into 2 groups according to DAPT duration and stent type: 3-month DAPT following Endeavor zotarolimus-eluting stent (E-ZES) implantation (E-ZES+3-month DAPT, n = 1,059) versus 12-month DAPT following the other DES implantation (standard therapy, n = 1,058). We hypothesized that the E-ZES+3-month DAPT would be noninferior to the standard therapy for the primary composite endpoint (cardiovascular death, myocardial infarction, stent thrombosis, target\vessel revascularization, or bleeding) at 1 year. Results: The primary endpoint occurred in 40 (4.7%) patients assigned to E-ZES+3-month DAPT compared with 41 (4.7%) patients assigned to the standard therapy (difference: 0.0%; 95% confidence interval [CI]: -2.5 to 2.5; p = 0.84; p < 0.001 for noninferiority). The composite rates of any death, myocardial infarction, or stent thrombosis were 0.8% and 1.3%, respectively (difference: -0.5%; 95% CI: -1.5 to 0.5; p = 0.48). The rates of stent thrombosis were 0.2% and 0.3%, respectively (difference: -0.1%; 95% CI: -0.5 to 0.3; p = 0.65) without its further occurrence after cessation of clopidogrel in the E-ZES+3-month DAPT group. The rates of target vessel revascularization were 3.9% and 3.7%, respectively (difference: 0.2%; 95% CI: -2.3 to 2.6; p = 0.70). Conclusions: E-ZES+3-month DAPT was noninferior to the standard therapy with respect to the occurrence of the primary endpoint. (REal Safety and Efficacy of a 3-month dual antiplatelet Therapy following E-ZES implantation [RESET]; NCT01145079)

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