东亚患者高出血风险定义学术研究联盟的验证
Validation of Academic Research Consortium for High Bleeding Risk Definition in East-Asian Patients.
作者信息
Lee Jinho, Kim Min-Ju, Kim Mijin, Park Jinsun, Kim Hoyun, Cho Suji, Choi Yeonwoo, Lee Junghoon, Kim Ju Hyeon, Cha Sung Joo, Kim Tae Oh, Kang Do-Yoon, Lee Pil Hyung, Ahn Jung-Min, Park Seung-Jung, Park Duk-Woo
机构信息
Department of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
Department of Clinical Epidemiology and Biostatistics, Asan Medical Center, Seoul, Korea.
出版信息
JACC Asia. 2023 Feb 7;3(3):390-399. doi: 10.1016/j.jacasi.2022.11.012. eCollection 2023 Jun.
BACKGROUND
Clinical applicability of the Academic Research Consortium High Bleeding Risk (ARC-HBR) criteria in East-Asian patients receiving potent antiplatelet therapy for acute coronary syndromes (ACS) is still undetermined.
OBJECTIVES
The purpose of this study was to validate the ARC definition for HBR in East-Asian patients with ACS for invasive management.
METHODS
We analyzed data from the TICAKOREA (Ticagrelor Versus Clopidogrel in Asian/Korean Patients With ACS Intended for Invasive Management) trial and randomly assigned 800 Korean ACS subjects to receive, in a 1:1 ratio, ticagrelor or clopidogrel. Patients were considered HBR if they met at least 1 major or 2 minor ARC-HBR criteria. The primary bleeding endpoint was Bleeding Academic Research Consortium 3 or 5 bleeding and the primary ischemic endpoint was a major adverse cardiovascular event (MACE) (a composite of cardiovascular death, myocardial infarction, or stroke) at 12 months.
RESULTS
Among 800 randomized patients, 129 (16.3%) were categorized HBR patients. HBR patients, compared with non-HBR patients, had a higher incidence of Bleeding Academic Research Consortium 3 or 5 bleeding (10.0% vs 3.7%; HR: 2.98; 95% CI: 1.52-5.86; < 0.001) and MACE (14.3% vs 6.1%; HR: 2.35; 95% CI: 1.35-4.10; = 0.002). The relative treatment effect of ticagrelor or clopidogrel on primary bleeding and ischemic outcomes were different between each group.
CONCLUSIONS
This study validates the ARC-HBR definition in Korean ACS patients. Approximately 15% of patients qualified as HBR patients who were at increased risk not only for bleeding but also for thrombotic events. The clinical application of ARC-HBR to determine the relative effect of different antiplatelet regiments should be further investigated. (Safety and Efficacy of Ticagrelor Versus Clopidogrel in Asian/KOREAn Patients with Acute Coronary Syndromes Intended for Invasive Management [TICA KOREA]; NCT02094963).
背景
学术研究联盟高出血风险（ARC-HBR）标准在接受强效抗血小板治疗的东亚急性冠状动脉综合征（ACS）患者中的临床适用性尚未确定。
目的
本研究旨在验证ARC对东亚ACS患者进行侵入性治疗时高出血风险的定义。
方法
我们分析了TICAKOREA（替格瑞洛与氯吡格雷在拟进行侵入性治疗的亚洲/韩国ACS患者中的对比研究）试验的数据，并将800名韩国ACS受试者按1:1比例随机分配接受替格瑞洛或氯吡格雷治疗。如果患者符合至少1项主要或2项次要ARC-HBR标准，则被视为高出血风险患者。主要出血终点为出血学术研究联盟3型或5型出血，主要缺血终点为12个月时的主要不良心血管事件（MACE，心血管死亡、心肌梗死或卒中的复合事件）。
结果
在800名随机分组的患者中，129名（16.3%）被归类为高出血风险患者。与非高出血风险患者相比，高出血风险患者发生出血学术研究联盟3型或5型出血的发生率更高（10.0%对3.7%；HR：2.98；95%CI：1.52 - 5.86；P<0.001），发生MACE的发生率也更高（14.3%对6.1%；HR：2.35；95%CI：1.35 - 4.10；P = 0.002）。替格瑞洛或氯吡格雷对主要出血和缺血结局的相对治疗效果在每组之间有所不同。
结论
本研究验证了ARC-HBR定义在韩国ACS患者中的适用性。约15%的患者符合高出血风险患者标准，这些患者不仅出血风险增加，血栓形成事件风险也增加。应进一步研究ARC-HBR在确定不同抗血小板治疗方案相对效果方面的临床应用。（替格瑞洛与氯吡格雷在拟进行侵入性治疗的亚洲/韩国急性冠状动脉综合征患者中的安全性和有效性对比研究[TICA KOREA]；NCT02094963）
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