Pareek Manan, Johansen Niklas Dyrby, Modin Daniel, Loiacono Matthew M, Harris Rebecca C, Dufournet Marine, Larsen Carsten Schade, Larsen Lykke, Wiese Lothar, Dalager-Pedersen Michael, Claggett Brian L, Janstrup Kira Hyldekær, Bartholdy Katja Vu, Bernholm Katrine Feldballe, Borchsenius Julie Inge-Marie Helene, Davidovski Filip Søskov, Davodian Lise Witten, Dons Maria, Duus Lisa Steen, Espersen Caroline, Fussing Frederik Holme, Jensen Anne Marie Reimer, Landler Nino Emanuel, Langhoff Adam Cadovius Femerling, Lassen Mats Christian Højbjerg, Nielsen Anne Bjerg, Ottosen Camilla Ikast, Sengeløv Morten, Skaarup Kristoffer Grundtvig, Solomon Scott D, Landray Martin J, Gislason Gunnar H, Køber Lars, Sivapalan Pradeesh, Martel Cyril Jean-Marie, Jensen Jens Ulrik Stæhr, Biering-Sørensen Tor
Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte, Gentofte Hospitalsvej 8, 3.th., Hellerup 2900, Denmark.
Center for Translational Cardiology and Pragmatic Randomized Trials, Faculty of Health and Medical Sciences, Department of Biomedical Sciences, University of Copenhagen, Gentofte Hospitalsvej 8, 3.th., Hellerup 2900, Denmark.
Eur Heart J. 2025 Aug 30. doi: 10.1093/eurheartj/ehaf678.
The aim was to evaluate and compare the relative vaccine effectiveness (rVE) of high-dose (HD-IIV) vs. standard-dose inactivated influenza vaccination (SD-IIV) on respiratory and cardiovascular outcomes in persons with or without pre-existing atherosclerotic cardiovascular disease (ASCVD).
A prespecified exploratory analysis of a pragmatic, open-label, individually randomized trial conducted in Denmark during three influenza seasons. Adults ≥65 years were randomized 1:1 to HD-IIV or SD-IIV. Baseline and outcome data were collected through nationwide registries. The primary outcome was hospitalization for influenza or pneumonia. Major adverse cardiovascular events (MACE) was defined as a composite of cardiovascular death, hospitalization for myocardial infarction, or hospitalization for stroke. Heterogeneity in rVE among participants with vs. without ASCVD was assessed.
The incidence of 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). 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). 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). 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).
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.
旨在评估和比较高剂量（HD-IIV）与标准剂量灭活流感疫苗（SD-IIV）对患有或未患有动脉粥样硬化性心血管疾病（ASCVD）的人群在呼吸和心血管结局方面的相对疫苗效力（rVE）。
对在丹麦三个流感季节进行的一项实用、开放标签、个体随机试验进行预先指定的探索性分析。≥65岁的成年人按1:1随机分配至HD-IIV或SD-IIV组。通过全国性登记处收集基线和结局数据。主要结局为因流感或肺炎住院。主要不良心血管事件（MACE）定义为心血管死亡、心肌梗死住院或中风住院的综合情况。评估有ASCVD与无ASCVD参与者之间rVE的异质性。
患有ASCVD的参与者（n = 46825）与未患有ASCVD的参与者（n = 285613）相比，所有结局的发生率更高。有ASCVD与无ASCVD的参与者之间rVE一致（所有P交互作用≥0.05）。在无ASCVD的个体中，主要结局的rVE为6.87%[95%置信区间（CI），-2.52至15.42]，在有ASCVD的个体中为4.71%（95%CI，-11.58至18.63）（P交互作用 = 0.80）。对于流感住院，无ASCVD者的rVE为42.88%（95%CI，22.07 - 58.44），有ASCVD者为45.73%（95%CI，16.68 - 65.16）（P交互作用 = 0.84）。对于MACE，无ASCVD的参与者中rVE为4.29%（95%CI，-6.50至14.00），有ASCVD的参与者中为0.30%（95%CI，-17.56至15.44）（P交互作用 = 0.68）。
在≥65岁的个体中，HD-IIV与SD-IIV在预防呼吸和心血管结局方面的rVE在有ASCVD与无ASCVD的人群中相似。
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