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.

IF 5.3 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS European Heart Journal - Cardiovascular Pharmacotherapy Pub Date : 2024-08-14 DOI:10.1093/ehjcvp/pvae009

Yuki Obayashi, Masahiro Natsuaki, Hirotoshi Watanabe, Takeshi Morimoto, Ko Yamamoto, Ryusuke Nishikawa, Kenji Ando, Satoru Suwa, Tsuyoshi Isawa, Hiroyuki Takenaka, Tetsuya Ishikawa, Hideo Tokuyama, Hiroki Sakamoto, Takanari Fujita, Mamoru Nanasato, Hideki Okayama, Tenjin Nishikura, Hidekuni Kirigaya, Koji Nishida, Koh Ono, Takeshi Kimura

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Abstract

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.

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基于急性冠脉综合征亚型和高出血风险的急性冠脉综合征经皮冠状动脉介入治疗无阿司匹林策略：STOPDAPT-3 试验。

背景与目的高出血风险（HBR）和急性冠状动脉综合征（ACS）亚型是决定经皮冠状动脉介入治疗（PCI）后出血和心血管事件风险的关键：STOPDAPT-3随机比较了PCI术后禁用阿司匹林和双联抗血小板疗法（DAPT）的策略，在入选STOPDAPT-3的4476例ACS患者中，根据HBR/非HBR和ST段抬高型心肌梗死（STEMI）/非ST段抬高型ACS（NSTE-ACS）进行了预先指定的亚组分析。共同主要出血终点为 BARC 3 型或 5 型，共同主要心血管终点为 1 个月时心血管死亡、心肌梗死、明确的支架血栓或缺血性卒中的复合终点：无论在哪个亚组，与 DAPT 相比，无阿司匹林对出血终点的影响都不显著（HBR [N = 1803]：7.27% 和 7.91%，HR 0.91，95%CI 0.65-1.28；非 HBR [N = 2673]：3.40% 和 3.65%，HR 0.91，95%CI 0.65-1.28）：在心血管终点方面（HBR：7.87%和5.75%，HR 0.93，95%CI 0.62-1.39；Pinteraction = 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；Pinteraction = 0.45），非HBR：3.40%和3.65%，HR 0.93，95%CI 0.62-1.39；Pinteraction = 0.94。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；Pinteraction = 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；Pinteraction = 0.18）：在接受PCI治疗的ACS患者中，无论HBR和ACS亚型如何，与DAPT策略相比，无阿司匹林策略未能减少大出血事件。在HBR患者和NSTE-ACS患者中观察到，相对于DAPT策略，无阿司匹林策略在心血管事件方面的超额风险在数值上高于DAPT策略。

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来源期刊

European Heart Journal - Cardiovascular Pharmacotherapy Medicine-Cardiology and Cardiovascular Medicine

CiteScore

10.10

自引率

14.10%

发文量

期刊介绍： The European Heart Journal - Cardiovascular Pharmacotherapy (EHJ-CVP) is an international, peer-reviewed journal published in English, specifically dedicated to clinical cardiovascular pharmacology. EHJ-CVP publishes original articles focusing on clinical research involving both new and established drugs and methods, along with meta-analyses and topical reviews. The journal's primary aim is to enhance the pharmacological treatment of patients with cardiovascular disease by interpreting and integrating new scientific developments in this field. While the emphasis is on clinical topics, EHJ-CVP also considers basic research articles from fields such as physiology and molecular biology that contribute to the understanding of cardiovascular drug therapy. These may include articles related to new drug development and evaluation, the physiological and pharmacological basis of drug action, metabolism, drug interactions, and side effects.