Long-Term Aspirin vs Clopidogrel After Coronary Stenting by Bleeding Risk and Procedural Complexity.

Background

To compare clopidogrel vs aspirin monotherapy in patients with HBR and/or PCI complexity.

比较氯吡格雷与阿司匹林单药治疗在HBR患者和/或PCI复杂性患者中的效果。

DESIGN, SETTING, AND PARTICIPANTS: This post hoc analysis of the multicenter HOST-EXAM Extended study, an open-label trial conducted across 37 sites in South Korea, enrolled patients from 2014 to 2018 with up to 5.9 years of follow-up.

设计、设置和参与者：这是对在韩国37个地点进行的多中心HOST-EXAM扩展研究的事后分析，这是一项开放标签试验，从2014年到2018年招募患者，随访时间最长可达5.9年。

The analysis was conducted from February to November 2023.

分析工作是从2023年2月到11月进行的。

Patients who maintained dual antiplatelet therapy (DAPT) event-free for 6 to 18 months following PCI were included.

在经皮冠状动脉介入治疗（PCI）后维持6至18个月无双抗血小板治疗（DAPT）事件的患者被纳入研究。

Methods

Patients were randomized to receive either clopidogrel or aspirin in a 1:1 ratio.

患者被随机分为1:1比例接受氯吡格雷或阿司匹林治疗。

Those with sufficient data to assess HBR or complex PCI were analyzed.

有足够的数据评估高出血风险(HBR)或复杂经皮冠状动脉介入治疗(PCI)的患者被纳入分析。

main_outcomes_and_measures

Coprimary end points were thrombotic composite end point (cardiovascular death, nonfatal myocardial infarction, stroke, readmission due to acute coronary syndrome, and definite/probable stent thrombosis) and any bleeding (Bleeding Academic Research Consortium type 2 to 5).

共同的主要终点是血栓性复合终点（心血管死亡、非致命性心肌梗死、中风、因急性冠状动脉综合征再入院以及确定/可能的支架血栓形成）和任何出血（出血学术研究联盟2至5型）。

Results

Of 3974 patients included (mean [SD] age, 63.4 [10.7] years; 2976 male [74.9%]), 866 had HBR (21.8%), and 849 underwent complex PCI (21.4%).

在纳入的3974名患者中（平均年龄[标准差]为63.4[10.7]岁；2976名为男性[74.9%]），866名患者具有高出血风险（21.8%），849名患者接受了复杂经皮冠状动脉介入治疗（PCI）（21.4%）。

Clopidogrel as compared with aspirin was associated with lower rates of thrombotic and bleeding events regardless of HBR and/or PCI complexity.

与阿司匹林相比，氯吡格雷与较低的血栓形成和出血事件发生率相关，无论是否存在高出血风险和/或经皮冠状动脉介入治疗（PCI）的复杂性。

For the thrombotic composite end point, the hazard ratio(HR) was 0.75 (95% CI, 0.53-1.04) among HBR vs 0.62 (95% CI, 0.48-0.80) among patients without HBR (P for interaction = 0.38) and 0.49 (95% CI, 0.32-0.77) among patients with complex PCI vs 0.74 (95% CI, 0.59-0.92) among patients with noncomplex PCI (P for interaction = 0.12).

对于血栓性复合终点，高出血风险（HBR）患者的危险比（HR）为0.75（95%置信区间，0.53-1.04），而非HBR患者为0.62（95%置信区间，0.48-0.80）（交互作用P值=0.38），复杂PCI患者为0.49（95%置信区间，0.32-0.77），非复杂PCI患者为0.74（95%置信区间，0.59-0.92）（交互作用P值=0.12）。

The reduction in bleeding by clopidogrel compared with aspirin was consistent among both patients with HBR (HR, 0.82; 95% CI, 0.56-1.21) and patients without HBR (HR, 0.58; 95% CI, 0.40-0.85; P for interaction = 0.20) and among patients undergoing complex PCI (HR, 0.79; 95% CI, 0.47-1.33) vs noncomplex PCI (HR, 0.68; 95% CI, 0.50-0.93; P for interaction = 0.62).

与阿司匹林相比，氯吡格雷减少出血的效果在HBR患者（HR，0.82；95%置信区间，0.56-1.21）和非HBR患者（HR，0.58；95%置信区间，0.40-0.85；交互作用P值=0.20）中是一致的，同样在进行复杂PCI的患者（HR，0.79；95%置信区间，0.47-1.33）和非复杂PCI的患者（HR，0.68；95%置信区间，0.50-0.93；交互作用P值=0.62）中也是一致的。

conclusions_and_relevance

In this study, in patients who experienced PCI and were event-free during 6 to 18 months of DAPT, the beneficial impact of clopidogrel monotherapy over aspirin monotherapy was consistent, regardless of bleeding risk and/or PCI complexity.

在这项研究中，接受经皮冠状动脉介入治疗（PCI）并在6至18个月的双联抗血小板治疗（DAPT）期间无事件发生的患者中，无论出血风险和/或PCI复杂性如何，氯吡格雷单药治疗相比阿司匹林单药治疗的有益影响是一致的。

trial_registration

ClinicalTrials.gov Identifier: NCT02044250.

ClinicalTrials.gov 注册号：NCT02044250。