Department of Internal Medicine, Cardiology Centre, Seoul National University Hospital, Seoul, South Korea.
Department of Internal Medicine, Ulsan University Hospital, Ulsan, South Korea.
Lancet. 2021 Jun 26;397(10293):2487-2496. doi: 10.1016/S0140-6736(21)01063-1. Epub 2021 May 16.
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.
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.
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).
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.
ChongKunDang, SamJin, HanMi, DaeWoong, and the South Korea Ministry of Health and Welfare.
在接受冠状动脉支架置入术的患者中，慢性维持期最佳的抗血小板单药治疗尚不清楚。我们旨在比较阿司匹林和氯吡格雷单药治疗在这一人群中的疗效和安全性。
我们在韩国的 37 个研究地点进行了一项由研究者发起的、前瞻性的、随机的、开放性标签的、多中心试验。我们纳入了年龄至少 20 岁的患者，这些患者在接受药物洗脱支架（DES）经皮冠状动脉介入治疗后，至少 6-18 个月内持续接受双联抗血小板治疗且无临床事件。我们排除了有任何缺血性和主要出血并发症的患者。患者被随机（1:1）分配接受氯吡格雷 75mg 每日一次或阿司匹林 100mg 每日一次的单药治疗，持续 24 个月。主要终点是在意向治疗人群中全因死亡、非致死性心肌梗死、卒中和因急性冠状动脉综合征再入院以及出血学术研究联合会（BARC）3 型或更高的出血复合终点。本试验在 ClinicalTrials.gov 注册，NCT02044250。
在 2014 年 3 月 26 日至 2018 年 5 月 29 日期间，我们纳入了 5530 名患者。5438 名（98.3%）患者被随机分配至氯吡格雷组（2710 名[49.8%]）或阿司匹林组（2728 名[50.2%]）。在 5338 名（98.2%）患者中完成了主要终点的评估。在 24 个月的随访期间，氯吡格雷组发生 152 例（5.7%）患者和阿司匹林组发生 207 例（7.7%）患者出现主要结局（风险比 0.73 [95%CI 0.59-0.90]；p=0.0035）。
与 DES 经皮冠状动脉介入治疗后慢性维持期的阿司匹林单药治疗相比，氯吡格雷单药治疗可显著降低全因死亡、非致死性心肌梗死、卒中和因急性冠状动脉综合征再入院以及 BARC 出血 3 型或更高的复合终点风险。在需要经皮冠状动脉介入治疗后进行无限期抗血小板单药治疗的患者中，氯吡格雷单药治疗在预防未来不良临床事件方面优于阿司匹林单药治疗。
ChongKunDang、SamJin、HanMi、DaeWoong 和韩国卫生部和福利部。
