复杂经皮冠状动脉介入治疗术后1个月以上阿司匹林与氯吡格雷单药治疗的比较：STOPDAPT-3试验的预先设定亚组分析
Aspirin vs. clopidogrel monotherapy beyond 1 month after complex percutaneous coronary intervention: a pre-specified subgroup analysis of the STOPDAPT-3 trial.
作者信息
Domei Takenori, Yamamoto Ko, Natsuaki Masahiro, Watanabe Hirotoshi, Morimoto Takeshi, Obayashi Yuki, Nishikawa Ryusuke, Kimura Tomoya, Ando Kenji, Suwa Satoru, Isawa Tsuyoshi, Takenaka Hiroyuki, Ishikawa Tetsuya, Tamura Toshihiro, Kawahatsu Kando, Hayashi Fujio, Abe Mitsuru, Serikawa Takeshi, Mori Hiroyoshi, Kawamura Takayuki, Hagikura Arata, Shibata Naoki, Ono Koh, Kimura Takeshi
机构信息
Department of Cardiology, Kokura Memorial Hospital, Kitakyushu 802-8555, Japan.
Department of Cardiovascular Medicine, Saga University, Saga 849-0937, Japan.
出版信息
Eur Heart J Cardiovasc Pharmacother. 2025 Mar 13;11(2):198-209. doi: 10.1093/ehjcvp/pvaf002.
AIMS
There were no previous studies comparing aspirin vs. P2Y12 inhibitor monotherapy following short dual antiplatelet therapy (DAPT) after complex percutaneous coronary intervention (PCI).
METHODS AND RESULTS
We conducted a pre-specified subgroup analysis based on complex PCI in the 1-year results of the STOPDAPT-3 (ShorT and OPtimal Duration of Dual AntiPlatelet Therapy-3) trial, which randomly compared 1-month DAPT followed by aspirin monotherapy (aspirin group) with 1-month prasugrel monotherapy followed by clopidogrel monotherapy (clopidogrel group). The main analysis in the present study was the 30-day landmark analysis. The co-primary endpoints were cardiovascular events (a composite of cardiovascular death, myocardial infarction, definite stent thrombosis, or stroke) and major bleeding (Bleeding Academic Research Consortium 3 or 5). In the 30-day landmark analysis (N = 5833), there were 1415 patients (24.3%) who underwent complex PCI. There was a significant interaction between complex PCI and the effect of the aspirin group relative to the clopidogrel group for cardiovascular events (complex PCI: 3.3% vs. 5.2%, non-complex PCI: 4.3% vs. 3.6%, interaction P = 0.04) and net adverse clinical events (complex PCI: 4.8% vs. 7.2%, non-complex PCI: 5.3% vs. 4.4%, interaction P = 0.02), but not for bleeding events (complex PCI: 2.1% vs. 2.7%, non-complex PCI: 1.7% vs. 1.4%, interaction P = 0.35).
CONCLUSIONS
There was a significant interaction between complex PCI and the effect of aspirin monotherapy relative to clopidogrel monotherapy beyond 1 month and up to 1 year for cardiovascular events due to numerically lower risk of aspirin monotherapy in patients with complex PCI, while the effect of aspirin monotherapy relative to clopidogrel monotherapy was not different for bleeding regardless of complex PCI.
CLINICAL TRIAL REGISTRATION
ShorT and OPtimal duration of Dual AntiPlatelet Therapy after everolimus-eluting cobalt-chromium stent-3 [STOPDAPT-3]; NCT04609111.
目的
既往尚无研究比较复杂经皮冠状动脉介入治疗（PCI）后短期双联抗血小板治疗（DAPT）后阿司匹林与P2Y12抑制剂单药治疗的效果。
方法与结果
我们在STOPDAPT-3（双联抗血小板治疗的短期和最佳疗程-3）试验的1年结果基础上，基于复杂PCI进行了一项预先设定的亚组分析，该试验将1个月DAPT后给予阿司匹林单药治疗（阿司匹林组）与1个月普拉格雷单药治疗后给予氯吡格雷单药治疗（氯吡格雷组）进行随机比较。本研究的主要分析是30天的标志性分析。共同主要终点是心血管事件（心血管死亡、心肌梗死、明确的支架血栓形成或中风的复合事件）和大出血（出血学术研究联盟3级或5级）。在30天的标志性分析（N = 5833）中，有1415例患者（24.3%）接受了复杂PCI。在心血管事件方面，复杂PCI与阿司匹林组相对于氯吡格雷组的疗效之间存在显著交互作用（复杂PCI：3.3%对5.2%，非复杂PCI：4.3%对3.6%，交互P = 0.04）以及净不良临床事件方面（复杂PCI：4.8%对7.2%，非复杂PCI：5.3%对4.4%，交互P = 0.02），但在出血事件方面不存在交互作用（复杂PCI：2.1%对2.7%，非复杂PCI：1.7%对1.4%，交互P = 0.35）。
结论
对于心血管事件，复杂PCI与阿司匹林单药治疗相对于氯吡格雷单药治疗在1个月后至1年的疗效之间存在显著交互作用，这是因为复杂PCI患者中阿司匹林单药治疗的风险在数值上较低，而无论是否为复杂PCI，阿司匹林单药治疗相对于氯吡格雷单药治疗在出血方面的效果并无差异。
临床试验注册
依维莫司洗脱钴铬支架置入术后双联抗血小板治疗的短期和最佳疗程-3 [STOPDAPT-3]；NCT04609111。
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