Aspirin, cardiovascular events, and major bleeding in older adults: extended follow-up of the ASPREE trial.

This study aimed to estimate long-term and post-trial effects of aspirin on major adverse cardiovascular events (MACE) and major haemorrhage using extended follow-up of participants from the ASPREE trial.

本研究旨在使用ASPREE试验参与者的长期随访数据，估计阿司匹林对主要不良心血管事件（MACE）和主要出血事件的长期和试验后效应。

Methods

In-trial (2010-17) and post-trial (2017-22) data were analysed.

分析了试验期间（2010-2017年）和试验后（2017-2022年）的数据。

At enrolment, participants were aged ≥70 years (≥65 years for US minorities) without prior cardiovascular events, dementia, or independence-limiting physical disability.

在入组时，参与者年龄≥70岁（美国少数族裔≥65岁），且没有既往心血管事件、痴呆或限制独立生活能力的身体残疾。

Randomization was to daily low-dose aspirin or matching placebo for the 4.7 years of the trial.

随机分配为每天低剂量阿司匹林或匹配安慰剂，为期试验的4.7年。

Results

Of the 19 114 participants randomized (9525 aspirin, 9589 placebo), 15 668 without in-trial MACE consented to post-trial follow-up.

在19,114名被随机分配的参与者中（9525名阿司匹林，9589名安慰剂），有15,668名在试验期间未发生主要不良心血管事件（MACE）的参与者同意进行试验后的随访。

No long-term benefit of randomization to aspirin was observed for MACE for the entire in-trial and post-trial period [hazard ratio(HR) 1.04, 95% confidence interval(CI) .94, 1.15].

在整个试验期间和试验后期间，随机分配到阿司匹林组对于主要不良心血管事件（MACE）没有长期益处[风险比（HR）1.04，95%置信区间（CI）0.94, 1.15]。

However, during the post-trial period (median 4.3 years), there was a higher rate of MACE (HR 1.17, 95% CI 1.01, 1.36) in those randomized to aspirin compared with placebo.

然而，在试验后期间（中位数4.3年），与安慰剂相比，随机分配到阿司匹林组的MACE发生率更高（HR 1.17，95% CI 1.01, 1.36）。

Over the entire period, a higher rate of major haemorrhage was observed in the randomized aspirin group compared with placebo (HR 1.24, 95% CI 1.10, 1.39).

在整个研究期间，与安慰剂组相比，随机分配到阿司匹林组的患者出现主要出血的比率更高（HR 1.24，95% 置信区间 1.10, 1.39）。

Conclusions

The present study provides novel evidence concerning long-term MACE and haemorrhage following aspirin use in initially healthy older adults.

本研究为长期使用阿司匹林在最初健康的老年人中引发的主要不良心血管事件（MACE）和出血提供了新的证据。

The finding of no long-term MACE benefit needs to be considered in clinical decision-making if aspirin is being considered for use in this context.

如果考虑在这种情况下使用阿司匹林，需要在临床决策中考虑没有长期主要不良心血管事件（MACE）益处的发现。