Lancet. 2021;397(10293):2487-2496.
Aspirin versus clopidogrel for chronic maintenance monotherapy after percutaneous coronary intervention (HOST-EXAM): an investigator-initiated, prospective, randomised, open-label, multicentre trial.
제1저자 구본권, 강지훈, 박경우 · 교신저자 김효수
소속 (14)
- Department of Internal Medicine, Cardiology Centre, Seoul National University Hospital, Seoul, South Korea.
- Department of Internal Medicine, Ulsan University Hospital, Ulsan, South Korea.
- Korea University Guro Hospital, Seoul, South Korea.
- Department of Internal Medicine, Chungbuk National University Hospital, Cheongju, South Korea.
- Department of Internal Medicine, Kangnam Sacred Heart Hospital, Hallym University, Seoul, South Korea.
- Department of Internal Medicine, Keimyung University Dongsan Hospital, Daegu, South Korea.
- Department of Internal Medicine, Yonsei University Wonju Severance Christian Hospital, Wonju, South Korea.
- Department of Internal Medicine, Dong-A University Hospital, Busan, South Korea.
- Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University, Seoul, South Korea.
- Department of Internal Medicine, CHA Bundang Medical Center, CHA University, Seongnam, South Korea.
- Department of Internal Medicine, Soonchunhyang University Bucheon Hospital, Bucheon, South Korea.
- Department of Internal Medicine, National Health Insurance Service Ilsan Hospital, Goyang, South Korea.
- Department of Internal Medicine, Boramae Medical Center, Seoul National University College of Medicine, Seoul, South Korea.
- Department of Internal Medicine, Cardiology Centre, Seoul National University Hospital, Seoul, South Korea. Electronic address: hyosoo@snu.ac.kr.
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.
Copyright © 2021 Elsevier Ltd. All rights reserved.
Comment · 정정
Conflict of interest statement
Declaration of interests H-SK has received research grants or speaker's fees from Medtronic, Abbott Vascular, Edwards Life Science, Boston Scientific, Terumo, Biotronik and Dio, AmGen, Pfizer, AstraZeneca, MSD, Daiichi Sankyo, and Boehringer Ingelheim. B-KK has received institutional research grants from Abbott Vascular and Philips. KWP reports fees from Daiichi Sankyo, AstraZeneca, Sanofi, Bristol-Myers Squibb, Bayer, and Pfizer outside the submitted work. All other authors declare no competing interests.
그 밖의 정보
- 출판 형태
- Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial
- 저널
- Lancet (London, England) · eISSN 1474-547X
- 전자 출판
- 2021-05-16
- MeSH
- Aged · Aspirin / therapeutic use · Clopidogrel / therapeutic use · Coronary Artery Disease / drug therapy / surgery · Drug-Eluting Stents* · Female · Humans · Male · Middle Aged · Percutaneous Coronary Intervention / methods · Platelet Aggregation Inhibitors / therapeutic use · Prospective Studies · Republic of Korea
- Substances
- Platelet Aggregation Inhibitors · Clopidogrel · Aspirin
- 데이터
- ClinicalTrials.gov: NCT02044250