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Safety of six-month dual antiplatelet therapy after second-generation drug-eluting stent implantation: OPTIMA-C Randomised Clinical Trial and OCT Substudy

 Byoung-Kwon Lee  ;  Jung-Sun Kim  ;  Oh-Huyn Lee  ;  Pil-Ki Min  ;  Young-Won Yoon  ;  Bum-Kee Hong  ;  Dong-Ho Shin  ;  Tae-Soo Kang  ;  Byung Ok Kim  ;  Duk-Kyu Cho  ;  Dong Woon Jeon  ;  Sung-Ill Woo  ;  Seonghoon Choi  ;  Yong Hoon Kim  ;  Woong-Chol Kang  ;  Seunghwan Kim  ;  Byeong-Keuk Kim  ;  Myeong-Ki Hong  ;  Yangsoo Jang  ;  Hyuck Moon Kwon 
 Eurointervention, Vol.13(16) : 1923-1930, 2018 
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AIMS: There are few randomised studies concerning the optimal duration of dual antiplatelet therapy (DAPT) for patients who receive a second-generation drug-eluting stent (DES). This trial aimed to investigate the safety of six-month compared with 12-month DAPT maintenance after second-generation DES implantation. METHODS AND RESULTS: A prospective, randomised, multicentre trial was performed at 10 medical centres. The 1,368 patients included in the study received a biolimus-eluting stent (BES) or a zotarolimus-eluting stent (ZES). The primary outcome measured was the composite of major adverse cardiac events (MACE), including cardiac death, myocardial infarction (MI), or ischaemia-driven target lesion revascularisation at the 12-month follow-up. The secondary outcome was the percentage of uncovered struts at six months in 60 patients (30 ZES, 30 BES) using optical coherence tomography (OCT) assessment. Each patient was randomly assigned to six-month (n=684) or 12-month DAPT (n=684). Major adverse cardiac events at 12 months occurred in eight patients (1.2%) in the six-month DAPT group and in four patients (0.6%) in the 12-month DAPT group (risk difference 0.6%; 95% confidence interval [CI]: -0.4-1.6%; p=0.24). The upper 95% CI limit was lower than the pre-specified limit of 4% non-inferiority (p for non-inferiority <0.05). The percentage of uncovered struts was 3.16+/-4.30% at six months in 60 stents of 60 patients. CONCLUSIONS: After second-generation DES implantation, six-month DAPT was not inferior to 12-month DAPT in terms of MACE occurrence over the 12-month follow-up period. OCT examination revealed favourable stent strut coverage at six months after stent implantation.
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1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
권혁문(Kwon, Hyuck Moon) ORCID logo https://orcid.org/0000-0001-9901-5015
김병극(Kim, Byeong Keuk) ORCID logo https://orcid.org/0000-0003-2493-066X
김중선(Kim, Jung Sun) ORCID logo https://orcid.org/0000-0003-2263-3274
민필기(Min, Pil Ki) ORCID logo https://orcid.org/0000-0001-7033-7651
신동호(Shin, Dong Ho) ORCID logo https://orcid.org/0000-0002-7874-5542
윤영원(Yoon, Young Won) ORCID logo https://orcid.org/0000-0002-0907-0350
이병권(Lee, Byoung Kwon) ORCID logo https://orcid.org/0000-0001-9259-2776
이오현(Lee, Oh Hyun) ORCID logo https://orcid.org/0000-0001-7070-7720
장양수(Jang, Yang Soo) ORCID logo https://orcid.org/0000-0002-2169-3112
홍명기(Hong, Myeong Ki) ORCID logo https://orcid.org/0000-0002-2090-2031
홍범기(Hong, Bum Kee) ORCID logo https://orcid.org/0000-0002-6456-0184
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