An aspirin-free strategy for percutaneous coronary intervention in patients with diabetes: a pre-specified subgroup analysis of the STOPDAPT-3 trial.

IF 5.3 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

European Heart Journal - Cardiovascular Pharmacotherapy Pub Date : 2024-10-23 DOI:10.1093/ehjcvp/pvae075

Ko Yamamoto, Masahiro Natsuaki, Hirotoshi Watanabe, Takeshi Morimoto, Yuki Obayashi, Ryusuke Nishikawa, Kenji Ando, Satoru Suwa, Tsuyoshi Isawa, Hiroyuki Takenaka, Tetsuya Ishikawa, Yuji Ikari, Tairo Kurita, Kazuaki Kaitani, Atsuhiko Sugimoto, Nobuhiko Ogata, Akihiro Ikuta, Katsushi Hashimoto, Yuki Ishibashi, Kazunori Masuda, Tomonori Miyabe, Koh Ono, Takeshi Kimura

{"title":"An aspirin-free strategy for percutaneous coronary intervention in patients with diabetes: a pre-specified subgroup analysis of the STOPDAPT-3 trial.","authors":"Ko Yamamoto, Masahiro Natsuaki, Hirotoshi Watanabe, Takeshi Morimoto, Yuki Obayashi, Ryusuke Nishikawa, Kenji Ando, Satoru Suwa, Tsuyoshi Isawa, Hiroyuki Takenaka, Tetsuya Ishikawa, Yuji Ikari, Tairo Kurita, Kazuaki Kaitani, Atsuhiko Sugimoto, Nobuhiko Ogata, Akihiro Ikuta, Katsushi Hashimoto, Yuki Ishibashi, Kazunori Masuda, Tomonori Miyabe, Koh Ono, Takeshi Kimura","doi":"10.1093/ehjcvp/pvae075","DOIUrl":null,"url":null,"abstract":"Aims: Safety of aspirin-free strategy immediately after percutaneous coronary intervention (PCI) for cardiovascular events in patients with diabetes was unknown.Methods and results: We conducted the prespecified subgroup analysis on diabetes in the STOPDAPT-3 trial, which randomly compared prasugrel (3.75 mg/day) monotherapy (2984 patients) to dual antiplatelet therapy (DAPT) with prasugrel and aspirin (2982 patients) in patients with acute coronary syndrome or high bleeding risk. The co-primary endpoints were major bleeding events (Bleeding Academic Research Consortium 3 or 5) and cardiovascular events (a composite of cardiovascular death, myocardial infarction, definite stent thrombosis, or stroke) at 1 month. Of 5966 study patients, there were 2715 patients (45.5%) with diabetes. Patients with diabetes more often had chronic coronary syndrome, heart failure or cardiogenic shock, and comorbidities than those without. Patients with diabetes compared to those without had higher incidences of major bleeding and cardiovascular events. Regardless of diabetes, the effect of no-aspirin relative to DAPT was not different for the co-primary bleeding (diabetes: 5.05% versus 5.47%; HR, 0.92; 95%CI, 0.66-1.28 and non-diabetes: 3.99% versus 4.07%; HR, 0.98; 95%CI, 0.69-1.38; P for interaction = 0.81) and cardiovascular (diabetes: 5.54% versus 5.15%; HR, 1.08; 95%CI, 0.78-1.49 and non-diabetes: 2.95% versus 2.47%; HR, 1.20; 95%CI, 0.79-1.82; P for interaction = 0.70) endpoints. The incidences of subacute definite or probable stent thrombosis and any coronary revascularization were higher in the no-aspirin group than in the DAPT group regardless of diabetes.Conclusions: The effects of an aspirin-free prasugrel monotherapy (3.75 mg/day) relative to DAPT for major bleeding and cardiovascular events were not different regardless of diabetes. Clinical trial registration: ShorT and OPtimal duration of Dual AntiPlatelet Therapy after everolimus-eluting cobalt-chromium stent-3 [STOPDAPT-3]; NCT04609111.","PeriodicalId":11982,"journal":{"name":"European Heart Journal - Cardiovascular Pharmacotherapy","volume":" ","pages":""},"PeriodicalIF":5.3000,"publicationDate":"2024-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"European Heart Journal - Cardiovascular Pharmacotherapy","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1093/ehjcvp/pvae075","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

Abstract

Aims: Safety of aspirin-free strategy immediately after percutaneous coronary intervention (PCI) for cardiovascular events in patients with diabetes was unknown.

Methods and results: We conducted the prespecified subgroup analysis on diabetes in the STOPDAPT-3 trial, which randomly compared prasugrel (3.75 mg/day) monotherapy (2984 patients) to dual antiplatelet therapy (DAPT) with prasugrel and aspirin (2982 patients) in patients with acute coronary syndrome or high bleeding risk. The co-primary endpoints were major bleeding events (Bleeding Academic Research Consortium 3 or 5) and cardiovascular events (a composite of cardiovascular death, myocardial infarction, definite stent thrombosis, or stroke) at 1 month. Of 5966 study patients, there were 2715 patients (45.5%) with diabetes. Patients with diabetes more often had chronic coronary syndrome, heart failure or cardiogenic shock, and comorbidities than those without. Patients with diabetes compared to those without had higher incidences of major bleeding and cardiovascular events. Regardless of diabetes, the effect of no-aspirin relative to DAPT was not different for the co-primary bleeding (diabetes: 5.05% versus 5.47%; HR, 0.92; 95%CI, 0.66-1.28 and non-diabetes: 3.99% versus 4.07%; HR, 0.98; 95%CI, 0.69-1.38; P for interaction = 0.81) and cardiovascular (diabetes: 5.54% versus 5.15%; HR, 1.08; 95%CI, 0.78-1.49 and non-diabetes: 2.95% versus 2.47%; HR, 1.20; 95%CI, 0.79-1.82; P for interaction = 0.70) endpoints. The incidences of subacute definite or probable stent thrombosis and any coronary revascularization were higher in the no-aspirin group than in the DAPT group regardless of diabetes.

Conclusions: The effects of an aspirin-free prasugrel monotherapy (3.75 mg/day) relative to DAPT for major bleeding and cardiovascular events were not different regardless of diabetes. Clinical trial registration: ShorT and OPtimal duration of Dual AntiPlatelet Therapy after everolimus-eluting cobalt-chromium stent-3 [STOPDAPT-3]; NCT04609111.

查看原文本刊更多论文

糖尿病患者经皮冠状动脉介入治疗的无阿司匹林策略：STOPDAPT-3 试验的预设亚组分析。

目的：糖尿病患者经皮冠状动脉介入治疗（PCI）后立即使用无阿司匹林策略治疗心血管事件的安全性尚不清楚：我们在 STOPDAPT-3 试验中对糖尿病患者进行了预设亚组分析，该试验随机比较了普拉格雷（3.75 毫克/天）单药治疗（2984 例患者）与普拉格雷和阿司匹林双联抗血小板治疗（DAPT）（2982 例患者）对急性冠脉综合征或高出血风险患者的治疗效果。共同主要终点是1个月时的大出血事件（出血学术研究联合会3级或5级）和心血管事件（心血管死亡、心肌梗死、明确的支架血栓或中风的复合）。在5966名研究患者中，有2715名患者（45.5%）患有糖尿病。与非糖尿病患者相比，糖尿病患者更多患有慢性冠状动脉综合征、心力衰竭或心源性休克以及合并症。与非糖尿病患者相比，糖尿病患者的大出血和心血管事件发生率更高。无论是否患有糖尿病，相对于 DAPT，无阿司匹林对共同主要出血的影响没有差异（糖尿病：5.05% 对 5.47%；HR，0.92；95%CI，0.66-1.28；非糖尿病：3.99% 对 4.07%；HR，0.98；95%CI，0.69-1.38；交互作用的 P = 0.81）和心血管（糖尿病：5.54% 对 5.15%；HR，1.08；95%CI，0.78-1.49 和非糖尿病：2.95% 对 2.47%；HR，1.20；95%CI，0.79-1.82；交互作用的 P = 0.70）终点。无论糖尿病与否，无阿司匹林组亚急性明确或可能的支架血栓形成和任何冠状动脉血运重建的发生率均高于DAPT组：结论：不含阿司匹林的普拉格雷单药治疗（3.75 mg/天）与DAPT相比，对大出血和心血管事件的影响没有差异，与糖尿病无关。临床试验注册：依维莫司洗脱钴铬支架后双联抗血小板疗法的最短疗程和最长疗程-3 [STOPDAPT-3]；NCT04609111。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

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.