Pareek Manan, Lassen Mats C Højbjerg, Johansen Niklas Dyrby, Christensen Sine H, Aliabadi Negar, Skaarup Kristoffer G, Modin Daniel, Claggett Brian L, Larsen Carsten S, Larsen Lykke, Wiese Lothar, Dalager-Pedersen Michael, Lindholm Matias G, Jensen Anne Marie R, Dons Maria, Bernholm Katrine F, Davidovski Filip S, Duus Lisa S, Ottosen Camilla I, Nielsen Anne B, Borchsenius Julie H, Espersen Caroline, Köse Güldas, Fussing Frederik H, Køber Lars, Solomon Scott D, Jensen Jens Ulrik Stæhr, Martel Cyril Jean-Marie, Gessner Bradford D, Schwarz Claudia, Gonzalez Elisa, Skovdal Mette, Zhang Pingping, Begier Elizabeth, 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, Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Gentofte Hospitalsvej 8, 3.th., Hellerup 2900, Denmark.
Eur Heart J. 2025 Aug 30. doi: 10.1093/eurheartj/ehaf679.
It is not known whether the bivalent respiratory syncytial virus prefusion F protein-based (RSVpreF) vaccine reduces outcomes in individuals with atherosclerotic cardiovascular disease (ASCVD). 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.
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. Baseline and outcome data were collected through nationwide registries. The primary outcome was respiratory syncytial virus-related respiratory tract disease hospitalization. The principal major adverse cardiovascular event outcome was a composite of hospitalization for myocardial infarction, stroke, or heart failure. Heterogeneity in VE was assessed among participants with and without ASCVD.
The incidence rate of almost all outcomes was higher in participants with pre-existing ASCVD (n = 14 241) vs those without (n = 117 035). Vaccine effectiveness was generally consistent by ASCVD status (Pinteraction ≥ .05 for all but one interaction). 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). 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).
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.
尚不清楚基于二价呼吸道合胞病毒预融合F蛋白的（RSVpreF）疫苗能否降低动脉粥样硬化性心血管疾病（ASCVD）患者的发病风险。本研究旨在评估RSVpreF疫苗与未接种疫苗相比，对有无ASCVD患者呼吸和心血管结局的疫苗效力（VE）。
我们对DAN-RSV试验进行了预先设定的二次分析。≥60岁的成年人按1:1随机分配至RSVpreF疫苗组或未接种疫苗组。基线和结局数据通过全国登记系统收集。主要结局是呼吸道合胞病毒相关的呼吸道疾病住院治疗。主要的主要不良心血管事件结局是心肌梗死、中风或心力衰竭住院的复合情况。在有和没有ASCVD的参与者中评估VE的异质性。
与没有ASCVD的参与者（n = 117035）相比，已有ASCVD的参与者（n = 14241）几乎所有结局的发生率都更高。疫苗效力在不同ASCVD状态下总体一致（除一次相互作用外，所有相互作用的P相互作用≥0.05）。在没有和有ASCVD的人群中，主要结局的VE分别为80.0%[95%置信区间（CI），29.3 - 96.3]和100.0%（95%CI，-141.3至100.0）（P相互作用>0.99）。在没有ASCVD的参与者中，主要不良心血管事件的疫苗效力为9.3%（95%CI，-15.1至28.6），在已有ASCVD的参与者中为12.0%（95%CI，-34.6至43.3）（P相互作用=0.90）。
在≥60岁的人群中，与没有ASCVD的个体相比，已有ASCVD的个体中，RSVpreF疫苗与未接种疫苗相比，在预防呼吸和心血管结局方面的VE相似。
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