{"title":"伴有或不伴有急性冠状动脉综合征的高出血风险患者的PCI无阿司匹林策略：来自stopdpt -3试验的亚组分析","authors":"Tetsuya Ishikawa, Masahiro Natsuaki, Hirotoshi Watanabe, Takeshi Morimoto, Ko Yamamoto, Yuki Obayashi, Ryusuke Nishikawa, Kenji Ando, Satoru Suwa, Tsuyoshi Isawa, Hiroyuki Takenaka, Ruka Yoshida, Hiroshi Suzuki, Gaku Nakazawa, Takanori Kusuyama, Itsuro Morishima, Syun Hojo, Joshi Tsutsumi, Hirosada Yamamoto, Hiroshi Ueda, Koh Ono, Takeshi Kimura","doi":"10.1161/CIRCINTERVENTIONS.124.015197","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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]; <i>P</i> 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]; <i>P</i> 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]; <i>P</i> interaction=0.02).</p><p><strong>Conclusions: </strong>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.</p><p><strong>Registration: </strong>URL: https://www.clinicaltrials.gov; Unique identifier: NCT04609111.</p>","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":" ","pages":"e015197"},"PeriodicalIF":6.1000,"publicationDate":"2025-05-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"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.\",\"authors\":\"Tetsuya Ishikawa, Masahiro Natsuaki, Hirotoshi Watanabe, Takeshi Morimoto, Ko Yamamoto, Yuki Obayashi, Ryusuke Nishikawa, Kenji Ando, Satoru Suwa, Tsuyoshi Isawa, Hiroyuki Takenaka, Ruka Yoshida, Hiroshi Suzuki, Gaku Nakazawa, Takanori Kusuyama, Itsuro Morishima, Syun Hojo, Joshi Tsutsumi, Hirosada Yamamoto, Hiroshi Ueda, Koh Ono, Takeshi Kimura\",\"doi\":\"10.1161/CIRCINTERVENTIONS.124.015197\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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]; <i>P</i> 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]; <i>P</i> 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]; <i>P</i> interaction=0.02).</p><p><strong>Conclusions: </strong>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.</p><p><strong>Registration: </strong>URL: https://www.clinicaltrials.gov; Unique identifier: NCT04609111.</p>\",\"PeriodicalId\":10330,\"journal\":{\"name\":\"Circulation: Cardiovascular Interventions\",\"volume\":\" \",\"pages\":\"e015197\"},\"PeriodicalIF\":6.1000,\"publicationDate\":\"2025-05-14\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Circulation: Cardiovascular Interventions\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1161/CIRCINTERVENTIONS.124.015197\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"CARDIAC & CARDIOVASCULAR SYSTEMS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Circulation: Cardiovascular Interventions","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1161/CIRCINTERVENTIONS.124.015197","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
引用次数: 0
摘要
背景：在接受经皮冠状动脉介入治疗的高危出血（HBR）、伴或不伴急性冠脉综合征（ACS）的患者中，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：在STOPDAPT-3试验（Short and Optimal Duration of Dual anti -血小板治疗-3）中，我们对HBR患者进行了按ACS分层的亚组分析，该试验随机比较了ACS和HBR患者的非阿司匹林（普拉格雷单药治疗）和双重抗血小板治疗（DAPT）。结果：HBR 3258例，其中ACS患者1803例，非ACS患者1455例。在经皮冠状动脉介入治疗1个月后，无论ACS或非ACS，无阿司匹林与DAPT对大出血的影响均不显著(7.3% vs.7.9%；风险比[HR]为0.91 [95% CI, 0.65-1.28]， 3.1%对2.9%；Hr, 1.06 [95% ci, 0.58-1.93]；P = 0.66)进行交互。与DAPT组相比，无阿司匹林组在ACS患者中心血管死亡、心肌梗死、明确支架血栓形成或缺血性卒中的综合风险较高，但在非ACS患者中没有(7.9% vs 5.8%；HR为1.39 [95% CI, 0.97-1.99]， 2.4%对3.0%；Hr, 0.78 [95% ci, 0.41-1.47]；P = 0.12)进行交互。心肌梗死的亚组治疗有显著的相互作用(1.6% vs 0.3%；HR为4.57 [95% CI, 1.31-15.89]， 1.4%对1.8%；Hr, 0.78 [95% ci, 0.34-1.77]；P = 0.02)进行交互。结论：与DAPT策略相比，无阿司匹林策略未能减少HBR患者的大出血，与ACS无关。在ACS患者中，无阿司匹林策略相对于DAPT策略在心血管事件（特别是心肌梗死）方面有额外的风险，但在非ACS患者中没有。无阿司匹林策略可能被认为是非acs患者经皮冠状动脉介入治疗后的潜在治疗选择。注册：网址：https://www.clinicaltrials.gov；唯一标识符：NCT04609111。
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.
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]; P 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]; P 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]; P 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.
期刊介绍：
Circulation: Cardiovascular Interventions, an American Heart Association journal, focuses on interventional techniques pertaining to coronary artery disease, structural heart disease, and vascular disease, with priority placed on original research and on randomized trials and large registry studies. In addition, pharmacological, diagnostic, and pathophysiological aspects of interventional cardiology are given special attention in this online-only journal.
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