한빛사논문
Sung-Jin Hong MDa,∗, Jung-Sun Kim MDa,∗, Soon Jun Hong MDb, Do-Sun Lim MDb, Seung-Yul Lee MDc, Kyeong Ho Yun MDc, Jong-Kwan Park MDd, Woong Chol Kang MDe, Yong Hoon Kim MDf, Hyuck-Jun Yoon MDg, Hoyoun Won MDh, Chung-Mo Nam PhDi, Chul-Min Ahn MDa, Byeong-Keuk Kim MDa, Young-Guk Ko MDa, Donghoon Choi MDa, Yangsoo Jang MDa, Myeong-Ki Hong MDa,# for the One-Month DAPT Investigators
aSeverance Cardiovascular Hospital, Yonsei University Health System, Seoul, Korea
bKorea University College of Medicine, Seoul, Korea
cWonkwang University Hospital, Iksan, Korea
dNational Health Insurance Service Ilsan Hospital, Goyang, Korea
eGachon University College of Medicine, Incheon, Korea
fKangwon National University School of Medicine, Chuncheon, Korea
gKeimyung University College of Medicine, Daegu, Korea
hChung-Ang University College of Medicine, Seoul, Korea
iDepartment of Preventive Medicine and Biostatistics, Yonsei University College of Medicine, Seoul, Korea
∗Drs. Sung-Jin Hong and Jung-Sun Kim contributed equally to this work.
#Corresponding author.
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. (A Randomized Controlled Comparison Between One Versus More Than Six Months of Dual Antiplatelet Therapy After Biolimus A9-Eluting Stent Implantation; NCT02513810)
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