Aspirin versus clopidogrel for chronic maintenance monotherapy after percutaneous coronary intervention: 10-year follow-up of the HOST-EXAM trial.

We conducted a 10-year follow-up of the HOST-EXAM trial to assess the very long-term effects of clopidogrel versus aspirin monotherapy in this setting.

我们对HOST-EXAM试验进行了10年的随访，以评估在这个背景下氯吡格雷与阿司匹林单药治疗的非常长期效果。

Methods

In HOST-EXAM, patients who had completed dual antiplatelet therapy without clinical events for 6-18 months after PCI were randomly assigned to receive clopidogrel 75 mg once daily or aspirin 100 mg once daily.

在HOST-EXAM研究中，完成经皮冠状动脉介入治疗（PCI）后6-18个月内未出现临床事件的患者被随机分配，每天一次接受75毫克的氯吡格雷或每天一次接受100毫克的阿司匹林。

This study is an investigator-initiated 10-year extended follow-up of the HOST-EXAM trial. The primary endpoint was a composite of all-cause death, non-fatal myocardial infarction, stroke, readmission due to acute coronary syndrome, and Bleeding Academic Research Consortium type ≥3 bleeding.

本研究是HOST-EXAM试验的10年延长随访，由研究者发起。主要终点是全因死亡、非致命性心肌梗死、中风、因急性冠脉综合征再入院以及Bleeding Academic Research Consortium 3级或以上出血的复合终点。

The primary analysis was done in the intention-to-treatpopulation.

主要分析在意向治疗人群中完成。

The study is registered with ClinicalTrials.gov (NCT02044250) and is complete.

该研究已在ClinicalTrials.gov上注册（NCT02044250），研究已完成。

Results

From March 26, 2014, to May 29, 2018, 5530 patients were enrolled and 5438 were randomly assigned to the aspirin group (n=2728) or the clopidogrel group (n=2710).

从2014年3月26日至2018年5月29日，共有5530名患者被纳入研究，并有5438名患者被随机分配到阿司匹林组（n=2728）或氯吡格雷组（n=2710）。

Clinical follow-up status was ascertained on May 1, 2025, resulting in a median follow-up duration of 10·5 years (IQR 9·4-11·4) after PCI and a completion rate of 92·8%.

2025年5月1日确定了临床随访状态，导致PCI后的中位随访时间为10.5年（四分位数间距9.4-11.4年），完成率为92.8%。

Clopidogrel was associated with a lower rate of the primary composite endpoint than aspirin (Kaplan-Meier estimate 25·4% for the clopidogrel group vs 28·5% for the aspirin group; hazard ratio0·86 [95% CI 0·77-0·96]; log-rank p=0·0050).

与阿司匹林相比，氯吡格雷与主要复合终点事件发生率较低有关（氯吡格雷组的Kaplan-Meier估计值为25.4%，阿司匹林组为28.5%；风险比为0.86 [95%置信区间0.77-0.96]；对数秩检验p=0.0050）。

Clopidogrel was also associated with a lower rate of the thrombotic endpoint (17·3% vs 20·0%; log-rank p=0·0024) and bleeding endpoint (9·1% vs 10·8%; log-rank p=0·020).

氯吡格雷还与血栓性终点事件发生率较低有关（17.3%对比20.0%；对数秩检验p=0.0024）以及出血性终点事件发生率较低（9.1%对比10.8%；对数秩检验p=0.020）。

All-cause mortality was similar between groups.

两组之间的全因死亡率相似。

interpretation

During 10 years of follow-up, clopidogrel monotherapy, compared with aspirin monotherapy, was associated with lower rates of the primary composite, ischaemic, and bleeding outcomes, but not all-cause mortality after PCI.

在10年的随访期间，与阿司匹林单药治疗相比，氯吡格雷单药治疗与主要复合终点、缺血性事件和出血事件的发生率较低有关，但在经皮冠状动脉介入治疗（PCI）后，全因死亡率并未降低。

These findings support consideration of clopidogrel as an alternative to aspirin for long-term antiplatelet monotherapy during the chronic maintenance phase after PCI.

这些发现支持在经皮冠状动脉介入治疗（PCI）后的慢性维持期长期抗血小板单药治疗中，考虑将氯吡格雷作为阿司匹林的替代品。

funding

Ministry of Health & Welfare, South Korea.

韩国卫生福利部