Prevention of Adverse Cardiovascular Events Using the 23-Valent Pneumococcal Polysaccharide Vaccine: A Randomized Clinical Trial.

Background

To determine whether pneumococcal vaccination (Pneumovax [Merck Sharp & Dohme Corp]) decreases the composite primary outcome of fatal and nonfatal acute coronary syndrome and ischemic stroke in people at increased risk, with an average follow-up of 7 years after immunization.

为了确定肺炎球菌疫苗（Pneumovax [默克夏普与多姆公司]）是否能降低高风险人群致命和非致命急性冠状动脉综合征及缺血性中风的复合主要结局，在接种疫苗后的平均随访7年。

DESIGN, SETTING, AND PARTICIPANTS: This was a double-blind, placebo-controlled, parallel-arm randomized clinical trial conducted at 6 centers across Australia.

这是一项在澳大利亚6个中心进行的双盲、安慰剂对照、平行组随机临床试验。

Participants were community-dwelling adults 55 to 60 years of age at baseline in 2016 to 2017, with at least 2 risk factors (obesity, hypertension, or hypercholesterolemia) for cardiovascular disease (CVD) but no prior CVD event or indication for early pneumococcal vaccination.

参与者为2016至2017年基线时年龄在55至60岁之间的社区居住成年人，至少具有2个心血管疾病（CVD）风险因素（肥胖、高血压或高胆固醇血症），但之前没有心血管事件或早期肺炎球菌疫苗接种的指征。

Data were analyzed from February 2023 to December 2024 using competing risk proportional hazards regression models, stratified by sex and center.

数据使用竞争风险比例风险回归模型进行分析，按性别和中心进行分层，分析时间从2023年2月到2024年12月。

Methods

Participants received either 23-valent PPV (PPV23) or placebo (saline).

参与者接受了23价肺炎球菌多糖疫苗（PPV23）或安慰剂（生理盐水）的治疗。

main_outcomes_and_measures

The primary outcome was a composite of fatal and nonfatal myocardial infarction or ischemic stroke, ascertained via electronic medical records from emergency department, admitted patient, and mortality data collections using International Statistical Classification of Diseases, Tenth Revision, Australian Modification (ICD-10-AM) codes.

主要结果是致命和非致命性心肌梗死或缺血性中风的复合终点，通过急诊、住院患者和死亡数据收集的电子病历确定，使用国际疾病分类第十次修订版澳大利亚修正版(ICD-10-AM)代码进行识别。

Results

A total of 4725 participants (mean [SD] age, 58.0 [1.7] years; 2433 male [52%]) were included in this study.

本研究共纳入4725名参与者（平均[标准差]年龄为58.0[1.7]岁；2433名男性[52%]）

There was no significant difference in the primary outcome (58 of 2366 events in the active PPV23 group compared with 64 of 2357 events in the control group, hazard ratio, 0.90; 95% CI, 0.63-1.28; P = .57).

主要结果没有显著差异（活性PPV23组2366个事件中有58个，对照组2357个事件中有64个，风险比为0.90；95%置信区间为0.63-1.28；P = .57）。

Similarly, no significant differences occurred in the exploratory outcomes of all-cause mortality, all-cause hospital presentations, and CVD-related hospital procedures.

同样，在全因死亡率、全因住院率和与心血管疾病相关的住院手术等探索性结果中，也没有出现显著差异。

These results are tempered by the lower than expected event rate leading to low power.

这些结果因低于预期的事件率而导致统计功效不足而有所保留。

conclusions_and_relevance

Results of this randomized clinical trial found that PPV23 did not reduce the rates of fatal and nonfatal acute coronary syndrome and ischemic stroke, although the study was underpowered.

这项随机临床试验的结果发现，PPV23并没有降低致命和非致命性急性冠状动脉综合征以及缺血性中风的发生率，尽管该研究的统计功效不足。

trial_registration

ANZCTR Identifier: ACTRN12615000536561.

ANZCTR 标识符：ACTRN12615000536561。