Aspirin and Hemocompatibility After LVAD Implantation in Patients With Atherosclerotic Vascular Disease: A Secondary Analysis From the ARIES-HM3 Randomized Clinical Trial.

This prespecified analysis explored whether conditions requiring aspirin (prior percutaneous coronary intervention [PCI], coronary artery bypass grafting [CABG], stroke, or peripheral vascular disease [PVD]) would influence outcomes differentially with aspirin avoidance.

这项预先设定的分析探讨了需要使用阿司匹林的情况（既往经皮冠状动脉介入治疗[PCI]、冠状动脉旁路移植术[CABG]、中风或周围血管疾病[PVD]）是否会因避免使用阿司匹林而对结果产生不同的影响。

Background

To analyze aspirin avoidance on hemocompatibility-related adverse events (HRAEs) at 1 year after implant in patients with a history of CABG, PCI, stroke, or PVD.

分析在有冠状动脉旁路移植术(CABG)、经皮冠状动脉介入治疗(PCI)、中风或周围血管疾病(PVD)病史的患者中，术后1年内避免使用阿司匹林对血液相容性相关不良事件(HRAEs)的影响。

DESIGN, SETTING, AND PARTICIPANTS: This was an international, multicenter, prospective, double-blind, placebo-controlled, randomized clinical trial including patients implanted with a de novo HM3 LVAD across 51 centers.

设计、设置和参与者：这是一项国际性的、多中心的、前瞻性、双盲、安慰剂对照的随机临床试验，包括在51个中心植入新型HM3左心室辅助装置(LVAD)的患者。

Data analysis was conducted from April to July 2024.

数据分析是从2024年4月到7月进行的。

Methods

Patients were randomized in a 1:1 ratio to receive aspirin (100 mg per day) or placebo, in addition to a vitamin K antagonist (VKA) targeted to an international normalized ratio of 2 to 3 in both groups.

患者按1:1的比例随机分配，接受阿司匹林（每天100毫克）或安慰剂治疗，同时两组均接受针对国际标准化比率2至3的维生素K拮抗剂（VKA）治疗。

main_outcomes_and_measures

Primary end point (assessed for noninferiority) was a composite of survival free of any nonsurgical (>14 days after implant) HRAEs including stroke, pump thrombosis, bleeding, and arterial peripheral thromboembolism at 12 months.

主要终点（评估非劣效性）是在植入后超过14天的任何非手术相关高风险不良事件（HRAEs）的生存情况，包括中风、泵血栓形成、出血和动脉周围血栓栓塞事件，在12个月时的复合结果。

Secondary end points included nonsurgical bleeding, stroke, and pump thrombosis events.

次要终点包括非手术出血、中风和泵血栓形成事件。

Results

Among 589 of 628 patients (mean [SD] age, 57.1 [13.7] years; 456 male [77.4%]) who contributed to the primary end point analysis, a history of PCI, CABG, stroke, or PVD was present in 41% (240 of 589 patients).

在628名患者中，有589名（平均年龄[标准差]为57.1[13.7]岁；456名为男性[77.4%]）对主要终点分析有贡献，其中41%（589名患者中的240名）有经皮冠状动脉介入治疗（PCI）、冠状动脉旁路移植术（CABG）、中风或周围血管疾病（PVD）的病史。

There was no interaction between the presence of an atherosclerotic vascular condition and effect of aspirin compared with placebo (P for interaction= .23).

动脉粥样硬化血管状况的存在与阿司匹林与安慰剂效果之间没有相互作用（相互作用的P值= .23）。

The preset 10% noninferiority margin was not crossed for the studied subgroup of patients.

所研究的患者亚组未超过10%的非劣效性界限。

Thrombotic events were rare, with no differences between aspirin and placebo in patients with and without vascular disease (P for interaction = .77).

血栓事件较为罕见，在有无血管疾病的患者中，阿司匹林与安慰剂之间没有差异（交互作用P值=0.77）。

Aspirin treatment was associated with a higher rate of nonsurgical major bleeding events in the group with prior vascular condition history compared with those without aspirin (rate ratio for placebo compared with aspirin, 0.52; 95% CI, 0.35-0.79).

在既往有血管疾病史的患者中，阿司匹林治疗与非手术性主要出血事件的较高发生率相关，与未使用阿司匹林的患者相比，安慰剂与阿司匹林的发生率比为0.52；95%置信区间为0.35-0.79。

conclusions_and_relevance

Results of this prespecified analysis of the ARIES-HM3 randomized clinical trial demonstrate that in patients with advanced heart failure who have classical indications for antiplatelet therapy use at the time of LVAD implantation, aspirin avoidance was safe and not associated with increased thrombosis risk.

ARIES-HM3随机临床试验的这一预先规定分析结果表明，在植入左心室辅助装置(LVAD)时具有经典抗血小板治疗指征的晚期心力衰竭患者中，避免使用阿司匹林是安全的，并且与血栓风险增加无关。

Importantly, elimination of aspirin was associated with no increased thrombosis but a reduction in nonsurgical bleeding events in patients with a history of PCI, CABG, stroke, or PVD.

重要的是，停用阿司匹林并未增加血栓事件，但在有经皮冠状动脉介入治疗（PCI）、冠状动脉旁路移植术（CABG）、中风或周围血管疾病（PVD）病史的患者中，非手术性出血事件有所减少。

trial_registration

ClinicalTrials.gov Identifier: NCT04069156.

ClinicalTrials.gov 注册号：NCT04069156。