High-dose vs. standard-dose inactivated influenza vaccine and cardiovascular outcomes in persons with or without pre-existing atherosclerotic cardiovascular disease: the DANFLU-2 trial.

Methods

A prespecified exploratory analysis of a pragmatic, open-label, individually randomized trial conducted in Denmark during three influenza seasons.

这是在丹麦进行的一项实用、开放标签、个体随机试验的预先设定的探索性分析，该试验在三个流感季节进行。

Adults ≥65 years were randomized 1:1 to HD-IIV or SD-IIV.

成人≥65岁被随机分为1:1接受高剂量四价流感疫苗(HD-IIV)或标准剂量四价流感疫苗(SD-IIV)。

Baseline and outcome data were collected through nationwide registries.

通过全国登记处收集基线数据和结果数据。

The primary outcome was hospitalization for influenza or pneumonia.

主要结果是因流感或肺炎住院。

Major adverse cardiovascular events (MACE) was defined as a composite of cardiovascular death, hospitalization for myocardial infarction, or hospitalization for stroke.

主要不良心血管事件（MACE）被定义为心血管死亡、因心肌梗死住院或因中风住院的复合结果。

Heterogeneity in rVE among participants with vs. without ASCVD was assessed.

评估了有无动脉粥样硬化性心血管疾病（ASCVD）参与者中相对风险值（rVE）的异质性。

Results

The incidenceof all outcomes was higher in participants with pre-existing ASCVD (n = 46 825) vs. those without (n = 285 613). rVE was consistent among participants with and without ASCVD (all Pinteraction ≥ .05).

所有结果的发生率在有既往ASCVD的参与者（n = 46,825）中比没有的参与者（n = 285,613）更高。有无ASCVD的参与者中rVE是一致的（所有P交互作用≥.05）。

The rVE for the primary outcome was 6.87% [95% confidence interval(CI), -2.52 to 15.42] among individuals without ASCVD and 4.71% (95% CI, -11.58 to 18.63) in those with (Pinteraction = .80).

在没有动脉粥样硬化性心血管疾病（ASCVD）的个体中，主要结果的相对疫苗效果（rVE）为6.87%（95%置信区间[CI]，-2.52至15.42），而在有ASCVD的个体中为4.71%（95% CI，-11.58至18.63）（P交互作用= .80）。

For influenza hospitalizations, the rVE was 42.88% (95% CI, 22.07-58.44) vs. 45.73% (95% CI, 16.68-65.16) in those without vs. with ASCVD (Pinteraction = .84).

对于流感住院，没有ASCVD的个体的相对疫苗效果（rVE）为42.88%（95% CI，22.07-58.44），而在有ASCVD的个体中为45.73%（95% CI，16.68-65.16）（P交互作用= .84）。

For MACE, the rVE was 4.29% (95% CI, -6.50 to 14.00) in participants without, and 0.30% (95% CI, -17.56 to 15.44) in participants with, pre-existing ASCVD (Pinteraction = .68).

对于主要不良心血管事件（MACE），在没有既往动脉粥样硬化性心血管疾病（ASCVD）的参与者中，相对风险效应（rVE）为4.29%（95%置信区间，-6.50至14.00），而在有既往ASCVD的参与者中，rVE为0.30%（95%置信区间，-17.56至15.44）（P交互作用 = .68）。

Conclusions

Among individuals ≥65 years, the rVE of HD-IIV vs. SD-IIV against respiratory and cardiovascular outcomes was similar among those with vs. without pre-existing ASCVD.

在≥65岁的个体中，高剂量灭活流感疫苗（HD-IIV）与标准剂量灭活流感疫苗（SD-IIV）相比，对于呼吸系统和心血管结果的相对风险效应（rVE）在有既往ASCVD的个体与没有既往ASCVD的个体之间是相似的。