急性冠状动脉综合征伴高出血风险或ST段抬高后1个月时阿司匹林与氯吡格雷的比较
Aspirin vs Clopidogrel 1 Month After Acute Coronary Syndrome With High-Bleeding Risk or ST-Segment Elevation.
作者信息
Obayashi Yuki, Natsuaki Masahiro, Watanabe Hirotoshi, Morimoto Takeshi, Yamamoto Ko, Nishikawa Ryusuke, Kimura Tomoya, Ando Kenji, Suwa Satoru, Isawa Tsuyoshi, Takenaka Hiroyuki, Ishikawa Tetsuya, Tokuyama Hideo, Sakamoto Hiroki, Fujita Takanari, Nanasato Mamoru, Okayama Hideki, Nishikura Tenjin, Kirigaya Hidekuni, Nishida Koji, Ono Koh, Kimura Takeshi
机构信息
Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
Department of Cardiovascular Medicine, Saga University, Saga, Japan.
出版信息
JACC Cardiovasc Interv. 2025 Sep 8;18(17):2120-2135. doi: 10.1016/j.jcin.2025.03.029. Epub 2025 Jun 4.
BACKGROUND
High bleeding risk (HBR) and acute coronary syndrome (ACS) subtypes (ST-segment elevation myocardial infarction [STEMI] and non-ST-segment elevation ACS [NSTE-ACS]) might be key determinants of appropriate antiplatelet strategies.
OBJECTIVES
The aim of this study was to investigate the effects of aspirin versus clopidogrel within 1 year after percutaneous coronary intervention in patients with ACS, on the basis of HBR or non-HBR and STEMI or NSTE-ACS.
METHODS
Patients with ACS in the STOPDAPT-3 (Short and Optimal Duration of Dual Antiplatelet Therapy-3) trial were included. Aspirin and clopidogrel monotherapy were compared beyond 30 days and up to 1 year in the prespecified subgroups stratified by HBR or non-HBR and STEMI or NSTE-ACS. The coprimary cardiovascular endpoint was a composite of cardiovascular death, myocardial infarction, definite stent thrombosis, or ischemic stroke; the coprimary bleeding endpoint was major bleeding (Bleeding Academic Research Consortium type 3 or 5).
RESULTS
Among 4,353 patients, 1,711 had HBR and 2,457 had STEMI. Throughout the 335-day follow-up period, the crude HRs for aspirin compared with clopidogrel were not statistically significant for cardiovascular endpoints in both the HBR or non-HBR (HR: 0.89 [95% CI: 0.61-1.30] and HR: 1.08 [95% CI: 0.61-1.90]; P for interaction = 0.59) and STEMI or NSTE-ACS (HR: 1.01 [95% CI: 0.68-1.50] and HR: 0.81 [95% CI: 0.48-1.37]; P for interaction = 0.51) subgroups. Similarly, the HRs for bleeding endpoints were not significant in both the HBR or non-HBR (HR: 0.73 [95% CI: 0.40-1.33] and HR: 0.71 [95% CI: 0.23-2.24]; P for interaction = 0.97) and STEMI or NSTE-ACS (HR: 0.96 [95% CI: 0.46-2.01] and HR: 0.53 [95% CI: 0.24-1.17]; P for interaction = 0.28) subgroups.
CONCLUSIONS
In patients with ACS, aspirin and clopidogrel demonstrated comparable effects on both cardiovascular and bleeding outcomes beyond 1 month and up to 1 year after percutaneous coronary intervention, irrespective of HBR or non-HBR and STEMI or NSTE-ACS. (Short and Optimal Duration of Dual Antiplatelet Therapy-3 Study [STOPDAPT-3]; NCT04609111).
背景
高出血风险（HBR）和急性冠状动脉综合征（ACS）亚型（ST段抬高型心肌梗死[STEMI]和非ST段抬高型ACS[NSTE-ACS]）可能是合适抗血小板策略的关键决定因素。
目的
本研究旨在基于HBR或非HBR以及STEMI或NSTE-ACS，调查ACS患者经皮冠状动脉介入治疗后1年内阿司匹林与氯吡格雷的疗效。
方法
纳入STOPDAPT-3（双联抗血小板治疗的短期和最佳疗程-3）试验中的ACS患者。在按HBR或非HBR以及STEMI或NSTE-ACS分层的预设亚组中，比较30天以上至1年的阿司匹林和氯吡格雷单药治疗。共同主要心血管终点是心血管死亡、心肌梗死、明确的支架血栓形成或缺血性卒中的复合终点；共同主要出血终点是大出血（出血学术研究联盟3型或5型）。
结果
在4353例患者中，1711例有HBR，2457例有STEMI。在整个335天的随访期内，在HBR或非HBR（HR：0.89[95%CI：0.61-1.30]和HR：1.08[95%CI：0.61-1.90]；交互作用P=0.59）以及STEMI或NSTE-ACS（HR：1.01[95%CI：0.68-1.50]和HR：0.81[95%CI：0.48-1.37]；交互作用P=0.51）亚组中，与氯吡格雷相比，阿司匹林治疗心血管终点的粗风险比无统计学意义。同样，在HBR或非HBR（HR：0.73[95%CI：0.40-1.33]和HR：0.71[95%CI：0.23-2.24]；交互作用P=0.97）以及STEMI或NSTE-ACS（HR：0.96[95%CI：0.46-2.01]和HR：0.53[95%CI：0.24-1.17]；交互作用P=0.28）亚组中，出血终点的风险比也无统计学意义。
结论
在ACS患者中，经皮冠状动脉介入治疗后1个月以上至1年，无论HBR或非HBR以及STEMI或NSTE-ACS如何，阿司匹林和氯吡格雷在心血管和出血结局方面显示出相似的效果。（双联抗血小板治疗的短期和最佳疗程-3研究[STOPDAPT-3]；NCT04609111）
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