Skaarup Kristoffer Grundtvig, 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, Bartholdy Katja Vu, Bernholm Katrine Feldballe, Borchsenius Julie Inge-Marie, 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, Solomon Scott D, Landray Martin J, Gislason Gunnar H, Køber Lars, Sivapalan Pradeesh, Martel Cyril Jean-Marie, Jensen Jens Ulrik Stæhr, Mebazaa Alexandre, Biering-Sørensen Tor
Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte & Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.
Sanofi, Morristown, NJ & Department of Epidemiology, University of Delaware, Newark, DE.
Circ Heart Fail. 2025 Aug 30. doi: 10.1161/CIRCHEARTFAILURE.125.013678.
Influenza contributes substantially to disease burden in individuals with heart failure (HF) and is an established trigger of cardiovascular (CV) and HF events. Standard-dose inactivated influenza vaccine (SD-IIV) is recommended for HF, though immune responses may be attenuated. High-dose IIV (HD-IIV) was developed to enhance immunogenicity, but its effectiveness compared with SD-IIV against hospitalization for influenza and CV disease by HF status remains uncertain. This was a prespecified analysis of a pragmatic, prospective, individually randomized, open-label trial with registry-based endpoint-evaluation conducted in Denmark across the 2022/2023 to 2024/2025 influenza seasons. Citizens ≥65 years were randomized 1:1 to HD-IIV or SD-IIV. Outcomes included hospitalization for influenza-related illness, laboratory-confirmed influenza (LCI), any CV disease, cardio-respiratory disease, and HF, assessed by HF status. Effect of HD-IIV vs. SD-IIV in reducing risk of outcomes assessed was expressed as risk ratios (RR). The trial randomized 332,438 participants (48.6% female, mean age 73.7±5.8 years), including 10,410 with HF at baseline (27.4% female, mean age 76.0±6.3 years). Overall, HD-IIV was associated with a statistically significant lower incidence of hospitalization for influenza-related illness, LCI, cardio-respiratory disease, CV disease, and HF compared with SD-IIV. In participants with HF, effect estimates were similar: RR for influenza-related hospitalization was 0.48 (95%CI, 0.20-1.06; p=0.64), for LCI hospitalization 0.55 (95%CI, 0.29-1.02; p=0.59), for cardio-respiratory hospitalization 0.89 (95%CI, 0.77-1.02; p=0.34), for CV hospitalization 0.86 (95%CI, 0.72-1.02; p=0.34), and for HF hospitalization 0.82 (95%CI, 0.61-1.11; p=0.83). Findings were consistent across HF subgroups by disease duration, recency of hospitalization, most recent N-terminal pro-B-type natriuretic peptide, and presence of device therapy. In this prespecified exploratory analysis of the largest individually randomized influenza vaccine trial ever conducted, HD-IIV was associated with lower rates of influenza and CV hospitalizations compared with SD-IIV, with effect estimates similar across HF status at baseline and HF subgroups.
流感在心力衰竭（HF）患者的疾病负担中占很大比例，并且是心血管（CV）和HF事件的既定触发因素。虽然免疫反应可能会减弱，但仍建议为HF患者接种标准剂量的灭活流感疫苗（SD-IIV）。高剂量流感疫苗（HD-IIV）的研发旨在增强免疫原性，但其与SD-IIV相比，针对HF状态下因流感和CV疾病住院的有效性仍不确定。这是一项预先设定的分析，该分析基于丹麦在2022/2023至2024/2025流感季节进行的一项务实、前瞻性、个体随机、开放标签试验，并进行基于登记的终点评估。65岁及以上的公民被1:1随机分配接受HD-IIV或SD-IIV。结局包括因流感相关疾病住院、实验室确诊的流感（LCI）、任何CV疾病、心肺疾病和HF，并根据HF状态进行评估。HD-IIV与SD-IIV在降低评估结局风险方面的效果以风险比（RR）表示。该试验随机分配了332,438名参与者（48.6%为女性，平均年龄73.7±5.8岁），其中包括10,410名基线时患有HF的参与者（27.4%为女性，平均年龄76.0±6.3岁）。总体而言，与SD-IIV相比，HD-IIV与因流感相关疾病、LCI、心肺疾病、CV疾病和HF住院的发生率在统计学上显著降低相关。在患有HF的参与者中，效果估计相似：因流感相关住院的RR为0.48（95%CI，0.20-1.06；p=0.64），因LCI住院的RR为0.55（95%CI，0.29-1.02；p=0.59），因心肺住院的RR为0.89（95%CI，0.77-1.02；p=0.34），因CV住院的RR为0.86（95%CI，0.72-1.02；p=0.34），因HF住院的RR为0.82（95%CI，0.61-1.11；p=0.83）。在按疾病持续时间（病程）、最近住院情况、最近的N末端B型利钠肽前体以及是否存在器械治疗划分的HF亚组中，研究结果一致。在这项有史以来规模最大的个体随机流感疫苗试验的预先设定的探索性分析中，与SD-IIV相比，HD-IIV与较低的流感和CV住院率相关，在基线HF状态和HF亚组中的效果估计相似。
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