基于急性冠状动脉综合征亚型和高出血风险的急性冠状动脉综合征患者行经皮冠状动脉介入治疗时的阿司匹林-free 策略：STOPDAPT-3 试验。
Aspirin-free strategy for percutaneous coronary intervention in acute coronary syndrome based on the subtypes of acute coronary syndrome and high bleeding risk: the STOPDAPT-3 trial.
机构信息
Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University, Kyoto 606-8507, Japan.
Department of Cardiovascular Medicine, Saga University, Saga 849-8501, Japan.
出版信息
Eur Heart J Cardiovasc Pharmacother. 2024 Aug 14;10(5):374-390. doi: 10.1093/ehjcvp/pvae009.
BACKGROUND AND AIMS
High bleeding risk (HBR) and acute coronary syndrome (ACS) subtypes are critical in determining bleeding and cardiovascular event risk after percutaneous coronary intervention (PCI).
METHODS AND RESULTS
In 4476 ACS patients enrolled in the STOPDAPT-3, where the no-aspirin and dual antiplatelet therapy (DAPT) strategies after PCI were randomly compared, the pre-specified subgroup analyses were conducted based on HBR/non-HBR and ST-segment elevation myocardial infarction (STEMI)/non-ST-segment elevation ACS (NSTE-ACS). The co-primary bleeding endpoint was Bleeding Academic Research Consortium (BARC) type 3 or 5, and the co-primary cardiovascular endpoint was a composite of cardiovascular death, myocardial infarction, definite stent thrombosis, or ischaemic stroke at 1 month. Irrespective of the subgroups, the effect of no-aspirin compared with DAPT was not significant for the bleeding endpoint (HBR [N = 1803]: 7.27 and 7.91%, hazard ratio (HR) 0.91, 95% confidence interval (CI) 0.65-1.28; non-HBR [N = 2673]: 3.40 and 3.65%, HR 0.93, 95% CI 0.62-1.39; Pinteraction = 0.94; STEMI [N = 2553]: 6.58 and 6.56%, HR 1.00, 95% CI 0.74-1.35; NSTE-ACS [N = 1923]: 2.94 and 3.64%, HR 0.80, 95% CI 0.49-1.32; Pinteraction = 0.45), and for the cardiovascular endpoint (HBR: 7.87 and 5.75%, HR 1.39, 95% CI 0.97-1.99; non-HBR: 2.56 and 2.67%, HR 0.96, 95% CI 0.60-1.53; Pinteraction = 0.22; STEMI: 6.07 and 5.46%, HR 1.11, 95% CI 0.81-1.54; NSTE-ACS: 3.03 and 1.71%, HR 1.78, 95% CI 0.97-3.27; Pinteraction = 0.18).
CONCLUSION
In patients with ACS undergoing PCI, the no-aspirin strategy compared with the DAPT strategy failed to reduce major bleeding events irrespective of HBR and ACS subtypes. The numerical excess risk of the no-aspirin strategy relative to the DAPT strategy for cardiovascular events was observed in patients with HBR and in patients with NSTE-ACS.
背景与目的
高出血风险（HBR）和急性冠状动脉综合征（ACS）亚型对于确定经皮冠状动脉介入治疗（PCI）后的出血和心血管事件风险至关重要。
方法和结果
在 4476 例 ACS 患者中进行了 STOPDAPT-3 研究，其中随机比较了 PCI 后的无阿司匹林和双联抗血小板治疗（DAPT）策略，根据 HBR/非 HBR 和 ST 段抬高心肌梗死（STEMI）/非 ST 段抬高 ACS（NSTE-ACS）进行了预先指定的亚组分析。主要出血终点为 Bleeding Academic Research Consortium（BARC）类型 3 或 5，主要心血管终点为 1 个月时心血管死亡、心肌梗死、明确支架血栓形成或缺血性卒中的复合终点。无论亚组如何，与 DAPT 相比，无阿司匹林的作用对出血终点均无显著影响（HBR [N=1803]：7.27%和 7.91%，风险比（HR）0.91，95%置信区间（CI）0.65-1.28；非 HBR [N=2673]：3.40%和 3.65%，HR 0.93，95% CI 0.62-1.39；P 交互=0.94；STEMI [N=2553]：6.58%和 6.56%，HR 1.00，95% CI 0.74-1.35；NSTE-ACS [N=1923]：2.94%和 3.64%，HR 0.80，95% CI 0.49-1.32；P 交互=0.45），且对心血管终点也无显著影响（HBR：7.87%和 5.75%，HR 1.39，95% CI 0.97-1.99；非 HBR：2.56%和 2.67%，HR 0.96，95% CI 0.60-1.53；P 交互=0.22；STEMI：6.07%和 5.46%，HR 1.11，95% CI 0.81-1.54；NSTE-ACS：3.03%和 1.71%，HR 1.78，95% CI 0.97-3.27；P 交互=0.18）。
结论
在接受 PCI 的 ACS 患者中，与 DAPT 策略相比，无阿司匹林策略并不能降低主要出血事件，无论 HBR 和 ACS 亚型如何。在 HBR 患者和 NSTE-ACS 患者中，无阿司匹林策略相对于 DAPT 策略的心血管事件的绝对风险增加。
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