根据房颤病史,高剂量与标准剂量流感疫苗对临床结果的相对疫苗有效性:对danfu -1随机试验的预先指定分析

European heart journal open Pub Date : 2025-08-21 eCollection Date: 2025-09-01 DOI:10.1093/ehjopen/oeaf102
Caroline Espersen, Niklas Dyrby Johansen, Daniel Modin, Kira Hyldekær Janstrup, Matthew M Loiacono, Rebecca C Harris, Tor Biering-Sørensen
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引用次数: 0

摘要

目的:房颤(AF)可能与流感相关的不良结局相关。我们根据af病史评估了高剂量(HD-IIV)与标准剂量(SD-IIV)灭活流感疫苗对心血管和全因住院和全因死亡率的相对疫苗有效性(rVE)。方法和结果:这是一项预先指定的DANFLU-1分析,这是一项实用的、开放标签的、可行性试验,在丹麦2021-2022年流感季节,65-79岁的成年人以1:1的比例随机接种HD-IIV或SD-IIV。基线和终点数据来自全国行政卫生登记处。预先指定的终点包括心血管住院和接种疫苗后14天至2022年5月31日发生的全因死亡率。在12477名随机参与者中,878名(7.0%)在基线时患有房颤。房颤患者年龄较大(73.0±3.8岁对71.7±3.9岁,P < 0.001),男性较多(70.7%对51.5%,P < 0.001),并伴有合并症。房颤住院率为75.5人/ 1000人/年,有房颤者为5.1人/ 1000人/年(P < 0.001)。无论房颤状态如何,hd - iv与sd - iv均与较低的全因死亡率相关(房颤:9个事件,rVE 54.1%, 95% CI -114.7 - 92.6%;无房颤:53个事件,rVE 48.3%, 95% CI 6.3-72.5%, p相互作用= 0.87)。无论房颤状态如何,hd - iv与房颤住院发生率降低无关(总rVE: 29.7%, 95% CI -13.9 ~ 57.1,相互作用= 0.51)。结论:尽管danfu -1不能用于临床终点,但无论房颤状态如何,hd - iv与sd - iv的全因死亡率均较低。无论房颤状态如何,与sd - iv相比,hd - iv与房颤住院发生率的显著降低无关。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Relative vaccine effectiveness of high-dose vs. standard-dose influenza vaccine against clinical outcomes according to history of atrial fibrillation: a pre-specified analysis of the DANFLU-1 randomized trial.

Relative vaccine effectiveness of high-dose vs. standard-dose influenza vaccine against clinical outcomes according to history of atrial fibrillation: a pre-specified analysis of the DANFLU-1 randomized trial.

Relative vaccine effectiveness of high-dose vs. standard-dose influenza vaccine against clinical outcomes according to history of atrial fibrillation: a pre-specified analysis of the DANFLU-1 randomized trial.

Relative vaccine effectiveness of high-dose vs. standard-dose influenza vaccine against clinical outcomes according to history of atrial fibrillation: a pre-specified analysis of the DANFLU-1 randomized trial.

Aims: Atrial fibrillation (AF) may be associated with adverse influenza-related outcomes. We assessed the relative vaccine effectiveness (rVE) of high-dose (HD-IIV) vs. standard-dose (SD-IIV) inactivated influenza vaccination against cardiovascular and all-cause hospitalizations and all-cause mortality according to history of AF.

Methods and results: This was a prespecified analysis of DANFLU-1, a pragmatic, open-label, feasibility trial randomizing adults aged 65-79 years 1:1 to HD-IIV or SD-IIV during the 2021-2022 influenza season in Denmark. Baseline and endpoint data were obtained from the nationwide administrative health registries. Prespecified endpoints included cardiovascular hospitalizations and all-cause mortality occurring 14 days after vaccination until 31 May 2022. Among 12 477 randomized participants, 878 (7.0%) had AF at baseline. Participants with AF were older (73.0 ± 3.8 vs. 71.7 ± 3.9 years, P < 0.001), more likely to be male (70.7% vs. 51.5%, P < 0.001) and have concomitant comorbidities. The incidence rate of hospitalization for AF was 75.5 vs. 5.1 per 1000 person-years for individuals with vs. without AF (P < 0.001). HD-IIV vs. SD-IIV was associated with a lower all-cause mortality rate irrespective of AF status (AF: 9 events, rVE 54.1%, 95% CI -114.7 to 92.6% vs. no AF: 53 events, rVE 48.3%, 95% CI 6.3-72.5%, pinteraction = 0.87). HD-IIV was not associated with a lower incidence of AF hospitalization regardless of AF status (overall rVE: 29.7%, 95% CI -13.9 to 57.1, pinteraction = 0.51).

Conclusion: Although DANFLU-1 was not powered for clinical endpoints, HD-IIV vs. SD-IIV was associated with lower all-cause mortality irrespective of AF status. HD-IIV compared with SD-IIV was not associated with a significantly lower incidence of AF hospitalizations regardless of AF status.

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