Bon-Kwon Koo1, Jeehoon Kang1, Kyung Woo Park1, Tae-Min Rhee1, Han-Mo Yang1, Ki-Bum Won2, Seung-Woon Rha3, Jang-Whan Bae4, Nam Ho Lee5, Seung-Ho Hur6, Junghan Yoon7, Tae-Ho Park8, Bum Soo Kim9, Sang Wook Lim10, Yoon Haeng Cho11, Dong Woon Jeon12, Sang-Hyun Kim13, Jung-Kyu Han1, Eun-Seok Shin2, Hyo-Soo Kim14. 1. Department of Internal Medicine, Cardiology Centre, Seoul National University Hospital, Seoul, South Korea. 2. Department of Internal Medicine, Ulsan University Hospital, Ulsan, South Korea. 3. Korea University Guro Hospital, Seoul, South Korea. 4. Department of Internal Medicine, Chungbuk National University Hospital, Cheongju, South Korea. 5. Department of Internal Medicine, Kangnam Sacred Heart Hospital, Hallym University, Seoul, South Korea. 6. Department of Internal Medicine, Keimyung University Dongsan Hospital, Daegu, South Korea. 7. Department of Internal Medicine, Yonsei University Wonju Severance Christian Hospital, Wonju, South Korea. 8. Department of Internal Medicine, Dong-A University Hospital, Busan, South Korea. 9. Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University, Seoul, South Korea. 10. Department of Internal Medicine, CHA Bundang Medical Center, CHA University, Seongnam, South Korea. 11. Department of Internal Medicine, Soonchunhyang University Bucheon Hospital, Bucheon, South Korea. 12. Department of Internal Medicine, National Health Insurance Service Ilsan Hospital, Goyang, South Korea. 13. Department of Internal Medicine, Boramae Medical Center, Seoul National University College of Medicine, Seoul, South Korea. 14. 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.
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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