高出血风险伴或不伴急性冠状动脉综合征患者PCI的无阿司匹林策略：来自STOPDAPT-3试验的亚组分析

Aspirin-Free Strategy for PCI in Patients With High Bleeding Risk With or Without Acute Coronary Syndrome: A Subgroup Analysis From the STOPDAPT-3 Trial.

作者信息

Ishikawa Tetsuya, Natsuaki Masahiro, Watanabe Hirotoshi, Morimoto Takeshi, Yamamoto Ko, Obayashi Yuki, Nishikawa Ryusuke, Ando Kenji, Suwa Satoru, Isawa Tsuyoshi, Takenaka Hiroyuki, Yoshida Ruka, Suzuki Hiroshi, Nakazawa Gaku, Kusuyama Takanori, Morishima Itsuro, Hojo Syun, Tsutsumi Joshi, Yamamoto Hirosada, Ueda Hiroshi, Ono Koh, Kimura Takeshi

机构信息

Department of Cardiology, Dokkyo Medical University Saitama Medical Center, Japan (T. Ishikawa).

Department of Cardiovascular Medicine, Saga University, Japan (M.N.).

出版信息

Circ Cardiovasc Interv. 2025 May 14:e015197. doi: 10.1161/CIRCINTERVENTIONS.124.015197.

DOI:10.1161/CIRCINTERVENTIONS.124.015197

PMID:40365675

Abstract

BACKGROUND

The effects of the aspirin-free strategy on bleeding and cardiovascular events were unknown in patients with high bleeding risk (HBR), with or without acute coronary syndrome (ACS), undergoing percutaneous coronary intervention.

METHODS

We conducted a subgroup analysis stratified by ACS among patients with HBR in the STOPDAPT-3 trial (Short and Optimal Duration of Dual Antiplatelet Therapy-3), which randomly compared no-aspirin (prasugrel monotherapy) with dual antiplatelet therapy (DAPT) in patients with ACS and HBR.

RESULTS

There were 3258 patients with HBR, including 1803 ACS and 1455 non-ACS patients. The effects of no-aspirin compared with DAPT at 1 month after percutaneous coronary intervention were not significant for major bleeding regardless of ACS or non-ACS (7.3% vs.7.9%; hazard ratio [HR], 0.91 [95% CI, 0.65-1.28], and 3.1% versus 2.9%; HR, 1.06 [95% CI, 0.58-1.93]; interaction=0.66). There was a numerically higher risk in the no-aspirin group relative to the DAPT group for a composite of cardiovascular death, myocardial infarction, definite stent thrombosis, or ischemic stroke in patients with ACS, but not in patients with non-ACS (7.9% versus 5.8%; HR, 1.39 [95% CI, 0.97-1.99], and 2.4% versus 3.0%; HR, 0.78 [95% CI, 0.41-1.47]; interaction=0.12). There was a significant treatment-by-subgroup interaction for myocardial infarction (1.6% versus 0.3%; HR, 4.57 [95% CI, 1.31-15.89], and 1.4% versus 1.8%; HR, 0.78 [95% CI, 0.34-1.77]; interaction=0.02).

CONCLUSIONS

The aspirin-free strategy compared with the DAPT strategy failed to reduce major bleeding in patients with HBR irrespective of ACS. There was a signal of the excess risk of the aspirin-free strategy relative to the DAPT strategy for cardiovascular events, myocardial infarction in particular, in patients with ACS, but not in patients with non-ACS. The aspirin-free strategy may be considered as a potential treatment option after percutaneous coronary intervention in patients with non-ACS.

REGISTRATION

URL: https://www.clinicaltrials.gov; Unique identifier: NCT04609111.

摘要

背景

对于有高出血风险（HBR）且无论有无急性冠脉综合征（ACS）的患者，在接受经皮冠状动脉介入治疗时，无阿司匹林策略对出血和心血管事件的影响尚不清楚。

方法

我们在STOPDAPT-3试验（双联抗血小板治疗的短期和最佳疗程-3）中，对HBR患者按是否患有ACS进行亚组分析，该试验将无阿司匹林治疗（普拉格雷单药治疗）与双联抗血小板治疗（DAPT）随机对照，纳入对象为患有ACS和HBR的患者。

结果

共有3258例HBR患者，其中1803例为ACS患者，1455例为非ACS患者。无论有无ACS，经皮冠状动脉介入治疗后1个月时，无阿司匹林治疗组与DAPT组相比，主要出血情况无显著差异（分别为7.3%对7.9%；风险比[HR]，0.91[95%CI，0.65 - 1.28]，以及3.1%对2.9%；HR，1.06[95%CI，0.58 - 1.93]；交互作用 = 0.66）。在ACS患者中，无阿司匹林治疗组相对于DAPT组，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风险在数值上更高，但在非ACS患者中并非如此（分别为7.9%对5.8%；HR，1.39[95%CI，0.97 - 1.99]，以及2.4%对3.0%；HR，0.78[95%CI，0.41 - 1.47]；交互作用 = 0.12）。心肌梗死存在显著的治疗与亚组交互作用（分别为1.6%对0.3%；HR，4.57[95%CI，1.31 - 15.89]，以及1.4%对1.8%；HR，0.78[95%CI，0.34 - 1.77]；交互作用 = 0.02）。