한빛사 논문
Prof Bon-Kwon Koo MDa,*, Jeehoon KangMDa,*, Kyung Woo Park MDa,*, Tae-Min Rhee MDa, Han-Mo Yang MDa, Ki-Bum Won MDb, Prof Seung-Woon Rha MDc, Jang-Whan Bae MDd, Prof Nam Ho Lee MDe, Prof Seung-Ho Hur MDf, Prof Junghan Yoon MDg, Tae-Ho Park MDh, Bum Soo Kim MDi, Prof Sang Wook Lim MDj, Yoon Haeng Cho MDk, Dong Woon Jeon MDl, Prof Sang-Hyun Kim MDm, Jung-Kyu Han MDa, Eun-Seok Shin MDb, Prof Hyo-Soo Kim MDa, on behalf of the HOST-EXAM investigators†
aDepartment of Internal Medicine, Cardiology Centre, Seoul National University Hospital, Seoul, South Korea
bDepartment of Internal Medicine, Ulsan University Hospital, Ulsan, South Korea
cKorea University Guro Hospital, Seoul, South Korea
dDepartment of Internal Medicine, Chungbuk National University Hospital, Cheongju, South Korea
eDepartment of Internal Medicine, Kangnam Sacred Heart Hospital, Hallym University, Seoul, South Korea
fDepartment of Internal Medicine, Keimyung University Dongsan Hospital, Daegu, South Korea
gDepartment of Internal Medicine, Yonsei University Wonju Severance Christian Hospital, Wonju, South Korea
hDepartment of Internal Medicine, Dong-A University Hospital, Busan, South Korea
iDepartment of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University, Seoul, South Korea
jDepartment of Internal Medicine, CHA Bundang Medical Center, CHA University, Seongnam, South Korea
kDepartment of Internal Medicine, Soonchunhyang University Bucheon Hospital, Bucheon, South Korea
lDepartment of Internal Medicine, National Health Insurance Service Ilsan Hospital, Goyang, South Korea
mDepartment of Internal Medicine, Boramae Medical Center, Seoul National University College of Medicine, Seoul, South Korea
*Authors contributed equally
†All investigators of the HOST-EXAM trial are listed in the appendix (pp 4-8)
Correspondence to: Prof Hyo-Soo Kim, Department of Internal Medicine, Cardiovascular Center, Seoul National University Hospital, Seoul, South Korea
Abstract
Background
Optimal antiplatelet monotherapy during the chronic maintenance period in patients who undergo coronary stenting is unknown. We aimed to compare head to head the efficacy and safety of aspirin and clopidogrel monotherapy in this population.
Methods
We did an investigator-initiated, prospective, randomised, open-label, multicentre trial at 37 study sites in South Korea. We enrolled patients aged at least 20 years who maintained dual antiplatelet therapy without clinical events for 6–18 months after percutaneous coronary intervention with drug-eluting stents (DES). We excluded patients with any ischaemic and major bleeding complications. Patients were randomly assigned (1:1) to receive a monotherapy agent of clopidogrel 75 mg once daily or aspirin 100 mg once daily for 24 months. The primary endpoint was a composite of all-cause death, non-fatal myocardial infarction, stroke, readmission due to acute coronary syndrome, and Bleeding Academic Research Consortium (BARC) bleeding type 3 or greater, in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, NCT02044250.
Findings
Between March 26, 2014, and May 29, 2018, we enrolled 5530 patients. 5438 (98·3%) patients were randomly assigned to either the clopidogrel group (2710 [49·8%]) or to the aspirin group (2728 [50·2%]). Ascertainment of the primary endpoint was completed in 5338 (98·2%) patients. During 24-month follow-up, the primary outcome occurred in 152 (5·7%) patients in the clopidogrel group and 207 (7·7%) in the aspirin group (hazard ratio 0·73 [95% CI 0·59–0·90]; p=0·0035).
Interpretation
Clopidogrel monotherapy, compared with aspirin monotherapy during the chronic maintenance period after percutaneous coronary intervention with DES significantly reduced the risk of the composite of all-cause death, non-fatal myocardial infarction, stroke, readmission due to acute coronary syndrome, and BARC bleeding type 3 or greater. In patients requiring indefinite antiplatelet monotherapy after percutaneous coronary intervention, clopidogrel monotherapy was superior to aspirin monotherapy in preventing future adverse clinical events.
Funding
ChongKunDang, SamJin, HanMi, DaeWoong, and the South Korea Ministry of Health and Welfare.
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