Effectiveness of bivalent respiratory syncytial virus prefusion F protein-based vaccine in individuals with or without atherosclerotic cardiovascular disease: the DAN-RSV trial.

The aim was to evaluate the vaccine effectiveness (VE) of an RSVpreF vaccine vs no vaccine on respiratory and cardiovascular outcomes in persons with or without pre-existing ASCVD.

本研究的目标是评估RSVpreF疫苗与无疫苗相比，在有或无既往动脉粥样硬化性心血管疾病（ASCVD）的个体中对呼吸系统和心血管结局的疫苗有效性（VE）。

Methods

We conducted a prespecified secondary analysis of the DAN-RSV trial. Adults aged ≥60 years were randomized 1:1 to RSVpreF vaccine or no vaccine.

我们对DAN-RSV试验进行了预先设定的次要分析。将≥60岁的成人随机分为1:1，接受RSVpreF疫苗或不接受疫苗。

Baseline and outcome data were collected through nationwide registries.

通过全国登记处收集基线和结果数据。

The primary outcome was respiratory syncytial virus-related respiratory tract disease hospitalization.

主要结果是呼吸道合胞病毒相关呼吸道疾病住院。

The principal major adverse cardiovascular event outcome was a composite of hospitalization for myocardial infarction, stroke, or heart failure.

主要重大不良心血管事件的结果是心肌梗死、中风或心力衰竭住院的复合结果。

Heterogeneity in VE was assessed among participants with and without ASCVD.

在有无动脉粥样硬化性心血管疾病（ASCVD）的参与者之间评估了血管扩张（VE）的异质性。

Results

The incidencerate of almost all outcomes was higher in participants with pre-existing ASCVD (n = 14 241) vs those without (n = 117 035).

几乎所有结果的发生率在有既往ASCVD的参与者（n = 14,241）中都比没有的参与者（n = 117,035）高。

Vaccine effectiveness was generally consistent by ASCVD status (Pinteraction ≥ .05 for all but one interaction).

疫苗有效性在动脉粥样硬化性心血管疾病（ASCVD）状态中总体上保持一致（除一个相互作用外，所有Pinteraction ≥ .05）。

Among persons without and with ASCVD, VE for the primary outcome was 80.0% [95% confidence interval(CI), 29.3-96.3] vs 100.0% (95% CI, -141.3 to 100.0), respectively (Pinteraction > .99).

在没有和有ASCVD的人群中，主要结果的疫苗有效性分别为80.0% [95% 置信区间 (CI), 29.3-96.3] 和 100.0% (95% CI, -141.3 到 100.0)（Pinteraction > .99）。

Vaccine effectiveness for major adverse cardiovascular events was 9.3% (95% CI, -15.1 to 28.6) in participants without, and 12.0% (95% CI, -34.6 to 43.3) in participants with, pre-existing ASCVD (Pinteraction = .90).

在没有既往动脉粥样硬化性心血管疾病（ASCVD）的参与者中，针对主要不良心血管事件的疫苗有效性为9.3%（95%置信区间，-15.1至28.6），而在有既往ASCVD的参与者中为12.0%（95%置信区间，-34.6至43.3）（P交互作用 = .90）。

Conclusions

The VE of an RSVpreF vaccine vs no vaccine against respiratory and cardiovascular outcomes was similar among individuals ≥ 60 years of age with pre-existing ASCVD as compared with those without.

在≥60岁的个体中，RSVpreF疫苗与无疫苗相比，针对呼吸系统和心血管结果的有效性在有既往动脉粥样硬化性心血管疾病（ASCVD）的个体中与无ASCVD的个体相似。