1-Month Dual-Antiplatelet Therapy Followed by Aspirin Monotherapy After Polymer-Free Drug-Coated Stent Implantation: One-Month DAPT Trial

One-Month DAPT Investigators

doi:10.1016/j.jcin.2021.06.003

1-Month Dual-Antiplatelet Therapy Followed by Aspirin Monotherapy After Polymer-Free Drug-Coated Stent Implantation: One-Month DAPT Trial

One-Month DAPT Investigators

Department of Biomedical Sciences

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

43 Citations (Scopus)

Abstract

Objectives: The aim of this study was to determine whether 1 month of dual-antiplatelet therapy (DAPT) followed by aspirin monotherapy after polymer-free drug-coated stent (PF-DCS) implantation is noninferior to 6 to 12 months of DAPT after biodegradable-polymer drug-eluting stent (BP-DES) implantation. Background: It is necessary to determine the optimal minimal duration of DAPT followed by aspirin monotherapy after percutaneous coronary intervention (PCI). Methods: In this trial, 3,020 patients with coronary artery disease considered for PCI for noncomplex lesions were randomized to 1-month DAPT after PF-DCS (n = 1,507) or 6- to 12-month DAPT after BP-DES (n = 1,513). The primary endpoint was the 1-year composite of cardiac death, nonfatal myocardial infarction, target vessel revascularization, stroke, or major bleeding (noninferiority hypothesis margin of 3%). Results: The primary endpoint occurred in 88 patients (5.9%) in the 1-month DAPT after PF-DCS group and 98 patients (6.5%) in the 6- to 12-month DAPT after BP-DES group (absolute difference −0.7%; upper limit of 1-sided 97.5% confidence interval: 1.33%; P < 0.001 for noninferiority). The occurrence of major bleeding was not different (1.7% vs 2.5%; P = 0.136). There was no difference in the occurrence of stent thrombosis (0.7% vs 0.8%; P = 0.842). Conclusions: Among patients who underwent PCI for noncomplex lesions, 1-month DAPT followed by aspirin monotherapy after PF-DCS implantation was noninferior to 6- to 12-month DAPT after BP-DES implantation for the 1-year composite of cardiovascular events or major bleeding. The present findings need to be interpreted in the setting of different types of stents according to antiplatelet strategy.

Original language	English
Pages (from-to)	1801-1811
Number of pages	11
Journal	JACC: Cardiovascular Interventions
Volume	14
Issue number	16
DOIs	https://doi.org/10.1016/j.jcin.2021.06.003
Publication status	Published - 2021 Aug 23

Bibliographical note

Funding Information:
This study was supported by the Cardiovascular Research Center (Seoul, South Korea) and funded by grants from DIO, Cardinal Health Korea, and Terumo Corporation. No funder or sponsor had any role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; or decision to submit the manuscript for publication. The authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Publisher Copyright:
© 2021 American College of Cardiology Foundation

Keywords

antiplatelet therapy
drug-eluting stent(s)
percutaneous coronary intervention

ASJC Scopus subject areas

Cardiology and Cardiovascular Medicine

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10.1016/j.jcin.2021.06.003

Cite this

@article{57991d1319bc43d5acd75712623337ce,

title = "1-Month Dual-Antiplatelet Therapy Followed by Aspirin Monotherapy After Polymer-Free Drug-Coated Stent Implantation: One-Month DAPT Trial",

abstract = "Objectives: The aim of this study was to determine whether 1 month of dual-antiplatelet therapy (DAPT) followed by aspirin monotherapy after polymer-free drug-coated stent (PF-DCS) implantation is noninferior to 6 to 12 months of DAPT after biodegradable-polymer drug-eluting stent (BP-DES) implantation. Background: It is necessary to determine the optimal minimal duration of DAPT followed by aspirin monotherapy after percutaneous coronary intervention (PCI). Methods: In this trial, 3,020 patients with coronary artery disease considered for PCI for noncomplex lesions were randomized to 1-month DAPT after PF-DCS (n = 1,507) or 6- to 12-month DAPT after BP-DES (n = 1,513). The primary endpoint was the 1-year composite of cardiac death, nonfatal myocardial infarction, target vessel revascularization, stroke, or major bleeding (noninferiority hypothesis margin of 3%). Results: The primary endpoint occurred in 88 patients (5.9%) in the 1-month DAPT after PF-DCS group and 98 patients (6.5%) in the 6- to 12-month DAPT after BP-DES group (absolute difference −0.7%; upper limit of 1-sided 97.5% confidence interval: 1.33%; P < 0.001 for noninferiority). The occurrence of major bleeding was not different (1.7% vs 2.5%; P = 0.136). There was no difference in the occurrence of stent thrombosis (0.7% vs 0.8%; P = 0.842). Conclusions: Among patients who underwent PCI for noncomplex lesions, 1-month DAPT followed by aspirin monotherapy after PF-DCS implantation was noninferior to 6- to 12-month DAPT after BP-DES implantation for the 1-year composite of cardiovascular events or major bleeding. The present findings need to be interpreted in the setting of different types of stents according to antiplatelet strategy.",

keywords = "antiplatelet therapy, drug-eluting stent(s), percutaneous coronary intervention",

author = "{One-Month DAPT Investigators} and Hong, {Sung Jin} and Kim, {Jung Sun} and Hong, {Soon Jun} and Lim, {Do Sun} and Lee, {Seung Yul} and Yun, {Kyeong Ho} and Park, {Jong Kwan} and Kang, {Woong Chol} and Kim, {Yong Hoon} and Yoon, {Hyuck Jun} and Hoyoun Won and Nam, {Chung Mo} and Ahn, {Chul Min} and Kim, {Byeong Keuk} and Ko, {Young Guk} and Donghoon Choi and Yangsoo Jang and Hong, {Myeong Ki}",

note = "Funding Information: This study was supported by the Cardiovascular Research Center (Seoul, South Korea) and funded by grants from DIO, Cardinal Health Korea, and Terumo Corporation. No funder or sponsor had any role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; or decision to submit the manuscript for publication. The authors have reported that they have no relationships relevant to the contents of this paper to disclose. Publisher Copyright: {\textcopyright} 2021 American College of Cardiology Foundation",

year = "2021",

month = aug,

day = "23",

doi = "10.1016/j.jcin.2021.06.003",

language = "English",

volume = "14",

pages = "1801--1811",

journal = "JACC: Cardiovascular Interventions",

issn = "1936-8798",

publisher = "Elsevier Inc.",

number = "16",

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TY - JOUR

T1 - 1-Month Dual-Antiplatelet Therapy Followed by Aspirin Monotherapy After Polymer-Free Drug-Coated Stent Implantation

T2 - One-Month DAPT Trial

AU - One-Month DAPT Investigators

AU - Hong, Sung Jin

AU - Kim, Jung Sun

AU - Hong, Soon Jun

AU - Lim, Do Sun

AU - Lee, Seung Yul

AU - Yun, Kyeong Ho

AU - Park, Jong Kwan

AU - Kang, Woong Chol

AU - Kim, Yong Hoon

AU - Yoon, Hyuck Jun

AU - Won, Hoyoun

AU - Nam, Chung Mo

AU - Ahn, Chul Min

AU - Kim, Byeong Keuk

AU - Ko, Young Guk

AU - Choi, Donghoon

AU - Jang, Yangsoo

AU - Hong, Myeong Ki

N1 - Funding Information: This study was supported by the Cardiovascular Research Center (Seoul, South Korea) and funded by grants from DIO, Cardinal Health Korea, and Terumo Corporation. No funder or sponsor had any role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; or decision to submit the manuscript for publication. The authors have reported that they have no relationships relevant to the contents of this paper to disclose. Publisher Copyright: © 2021 American College of Cardiology Foundation

PY - 2021/8/23

Y1 - 2021/8/23

N2 - Objectives: The aim of this study was to determine whether 1 month of dual-antiplatelet therapy (DAPT) followed by aspirin monotherapy after polymer-free drug-coated stent (PF-DCS) implantation is noninferior to 6 to 12 months of DAPT after biodegradable-polymer drug-eluting stent (BP-DES) implantation. Background: It is necessary to determine the optimal minimal duration of DAPT followed by aspirin monotherapy after percutaneous coronary intervention (PCI). Methods: In this trial, 3,020 patients with coronary artery disease considered for PCI for noncomplex lesions were randomized to 1-month DAPT after PF-DCS (n = 1,507) or 6- to 12-month DAPT after BP-DES (n = 1,513). The primary endpoint was the 1-year composite of cardiac death, nonfatal myocardial infarction, target vessel revascularization, stroke, or major bleeding (noninferiority hypothesis margin of 3%). Results: The primary endpoint occurred in 88 patients (5.9%) in the 1-month DAPT after PF-DCS group and 98 patients (6.5%) in the 6- to 12-month DAPT after BP-DES group (absolute difference −0.7%; upper limit of 1-sided 97.5% confidence interval: 1.33%; P < 0.001 for noninferiority). The occurrence of major bleeding was not different (1.7% vs 2.5%; P = 0.136). There was no difference in the occurrence of stent thrombosis (0.7% vs 0.8%; P = 0.842). Conclusions: Among patients who underwent PCI for noncomplex lesions, 1-month DAPT followed by aspirin monotherapy after PF-DCS implantation was noninferior to 6- to 12-month DAPT after BP-DES implantation for the 1-year composite of cardiovascular events or major bleeding. The present findings need to be interpreted in the setting of different types of stents according to antiplatelet strategy.

AB - Objectives: The aim of this study was to determine whether 1 month of dual-antiplatelet therapy (DAPT) followed by aspirin monotherapy after polymer-free drug-coated stent (PF-DCS) implantation is noninferior to 6 to 12 months of DAPT after biodegradable-polymer drug-eluting stent (BP-DES) implantation. Background: It is necessary to determine the optimal minimal duration of DAPT followed by aspirin monotherapy after percutaneous coronary intervention (PCI). Methods: In this trial, 3,020 patients with coronary artery disease considered for PCI for noncomplex lesions were randomized to 1-month DAPT after PF-DCS (n = 1,507) or 6- to 12-month DAPT after BP-DES (n = 1,513). The primary endpoint was the 1-year composite of cardiac death, nonfatal myocardial infarction, target vessel revascularization, stroke, or major bleeding (noninferiority hypothesis margin of 3%). Results: The primary endpoint occurred in 88 patients (5.9%) in the 1-month DAPT after PF-DCS group and 98 patients (6.5%) in the 6- to 12-month DAPT after BP-DES group (absolute difference −0.7%; upper limit of 1-sided 97.5% confidence interval: 1.33%; P < 0.001 for noninferiority). The occurrence of major bleeding was not different (1.7% vs 2.5%; P = 0.136). There was no difference in the occurrence of stent thrombosis (0.7% vs 0.8%; P = 0.842). Conclusions: Among patients who underwent PCI for noncomplex lesions, 1-month DAPT followed by aspirin monotherapy after PF-DCS implantation was noninferior to 6- to 12-month DAPT after BP-DES implantation for the 1-year composite of cardiovascular events or major bleeding. The present findings need to be interpreted in the setting of different types of stents according to antiplatelet strategy.

KW - antiplatelet therapy

KW - drug-eluting stent(s)

KW - percutaneous coronary intervention

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U2 - 10.1016/j.jcin.2021.06.003

DO - 10.1016/j.jcin.2021.06.003

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VL - 14

SP - 1801

EP - 1811

JO - JACC: Cardiovascular Interventions

JF - JACC: Cardiovascular Interventions

IS - 16

ER -

1-Month Dual-Antiplatelet Therapy Followed by Aspirin Monotherapy After Polymer-Free Drug-Coated Stent Implantation: One-Month DAPT Trial

Abstract

Bibliographical note

Keywords

ASJC Scopus subject areas

Access to Document

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