Clopidogrel vs Aspirin According to Diabetes Mellitus

IF 12.7 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

JACC. Cardiovascular interventions Pub Date : 2026-09-14 Epub Date: 2026-07-16 DOI:10.1016/j.jcin.2026.05.013

Sang Yoon Lee MD, Donghyeon Joo MD, Joo Myung Lee MD, Yong Hwan Park MD, Jong-Young Lee MD, Jin-Ok Jeong MD, Chan Joon Kim MD, Han Cheol Lee MD, Kiyuk Chang MD, Mahn-Won Park MD, Jang-Whan Bae MD, Joon-Hyung Doh MD, Byung Ryul Cho MD, Hee-Yeol Kim MD, Weon Kim MD, Ung Kim MD, Seung-Woon Rha MD, Young Joon Hong MD, Hyun-Jong Lee MD, Sung Gyun Ahn MD, Kyeong Ho Yun MD

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引用次数: 0

Abstract

Background

Recent trials support the superior efficacy of clopidogrel compared to aspirin monotherapy after completion of dual antiplatelet therapy (DAPT) in patients who have undergone percutaneous coronary intervention (PCI). However, limited evidence is available in patients with diabetes mellitus (DM).

Objectives

This study sought to evaluate the comparative efficacy and safety of clopidogrel vs aspirin monotherapy according to the presence of DM.

Methods

This was a prespecified analysis of the SMART-CHOICE 3 trial, which was a multicenter, open-label, randomized controlled trial comparing clopidogrel vs aspirin monotherapy in patients with complex coronary lesions or high-risk clinical characteristics. From August 2020 to July 2023, a total of 5,506 patients who underwent PCI and standard DAPT duration and had complex coronary lesions, DM, or previous myocardial infarction, were randomized to clopidogrel or aspirin monotherapy groups. The primary endpoint was major adverse cardiac and cerebrovascular events (MACCE), which was defined as a composite of death from any cause, myocardial infarction, or stroke.

Results

Of 5,506 patients, 2,089 had DM (1,039 in the clopidogrel group and 1,050 in the aspirin group). At a median follow-up of 2.3 years (IQR: 1.6-3.0 years), DM patients had a higher risk of MACCE compared to non-DM patients (6.8% vs 4.7%; HR: 1.44, 95% CI: 1.10-1.87; P = 0.008). Clopidogrel showed a significantly lower risk of MACCE than aspirin in DM patients (4.5% vs 9.1%; HR: 0.57, 95% CI: 0.38-0.86; P = 0.008). There was no significant interaction between DM and antiplatelet monotherapy regarding MACCE (P for interaction = 0.124). The risk of bleeding was comparable between the 2 groups in DM patients (2.9% vs 2.9%; HR: 1.06, 95% CI: 0.57-1.95; P = 0.855).

Conclusions

Among DM patients who completed the standard duration of DAPT after PCI, clopidogrel monotherapy was associated with a lower risk of a composite of death from any cause, myocardial infarction, and stroke compared with aspirin monotherapy, without increased rates of bleeding. There was no significant interaction between DM and antiplatelet monotherapy with respect to MACCE. (SMART-CHOICE 3 [SMart Angioplasty Research Team: CHoice of Optimal Anti-Thrombotic Strategy in Patients Undergoing Implantation of Coronary Drug-Eluting Stents 3]; NCT04418479)

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氯吡格雷与阿司匹林对糖尿病的影响

最近的试验支持氯吡格雷在经皮冠状动脉介入治疗（PCI）患者完成双重抗血小板治疗（DAPT）后的疗效优于阿司匹林单药治疗。然而，关于糖尿病患者的证据有限。目的：本研究旨在评估氯吡格雷与阿司匹林单药治疗在复杂冠状动脉病变或高危临床特征患者中的疗效和安全性。方法：SMART-CHOICE 3试验是一项多中心、开放标签、随机对照试验，比较氯吡格雷与阿司匹林单药治疗。从2020年8月至2023年7月，共有5506名接受PCI和标准DAPT持续时间且患有复杂冠状动脉病变、糖尿病或既往心肌梗死的患者被随机分为氯吡格雷或阿司匹林单药治疗组。主要终点是主要心脑血管不良事件（MACCE），定义为任何原因导致的死亡、心肌梗死或中风的复合死亡。结果5506例患者中，2089例患有糖尿病（氯吡格雷组1039例，阿司匹林组1050例）。在中位随访2.3年（IQR: 1.6-3.0年）时，糖尿病患者发生MACCE的风险高于非糖尿病患者（6.8% vs 4.7%; HR: 1.44, 95% CI: 1.10-1.87; P = 0.008）。在糖尿病患者中，氯吡格雷的MACCE风险明显低于阿司匹林（4.5% vs 9.1%; HR: 0.57, 95% CI: 0.38-0.86; P = 0.008）。在MACCE方面，DM与抗血小板单药治疗之间无显著相互作用（相互作用P = 0.124）。两组糖尿病患者的出血风险相当（2.9% vs 2.9%; HR: 1.06, 95% CI: 0.57-1.95; P = 0.855）。结论：在PCI术后完成DAPT标准疗程的DM患者中，与阿司匹林单药治疗相比，氯吡格雷单药治疗与任何原因死亡、心肌梗死和卒中的综合风险较低相关，且未增加出血发生率。在MACCE方面，DM和抗血小板单药治疗之间没有显著的相互作用。（SMart - CHoice 3[智能血管成形术研究小组：冠状动脉药物洗脱支架植入患者最佳抗血栓策略的选择]；NCT04418479）

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来源期刊

JACC. Cardiovascular interventions CARDIAC & CARDIOVASCULAR SYSTEMS-

CiteScore

11.60

自引率

8.80%

发文量

756

审稿时长

4-8 weeks

期刊介绍： JACC: Cardiovascular Interventions is a specialist journal launched by the Journal of the American College of Cardiology (JACC). It covers the entire field of interventional cardiovascular medicine, including cardiac, peripheral, and cerebrovascular interventions. The journal publishes studies that will impact the practice of interventional cardiovascular medicine, including clinical trials, experimental studies, and in-depth discussions by respected experts. To enhance visual understanding, the journal is published both in print and electronically, utilizing the latest technologies.