Bivalent RSV Prefusion F Protein-Based Vaccine for Preventing Cardiovascular Hospitalizations in Older Adults: A Prespecified Analysis of the DAN-RSV Trial.

A bivalent RSV prefusion F protein (RSVpreF) vaccine was recently approved for preventing RSV-related lower respiratory tract illness, but its effectiveness against cardiovascular outcomes has not been evaluated in a randomized trial.

一种双价RSV前融合F蛋白（RSVpreF）疫苗最近被批准用于预防RSV相关的下呼吸道疾病，但其对心血管结果的有效性尚未在随机试验中评估。

Background

To investigate the vaccine effectiveness of RSVpreF compared with no vaccine against cardiovascular outcomes among adults aged 60 years or older.

研究RSVpreF疫苗与无疫苗相比在60岁或以上成人中预防心血管事件的有效性。

DESIGN, SETTING, AND PARTICIPANTS: Prespecified secondary analysis of the DAN-RSV trial, a pragmatic, open-label, individually randomized clinical trial conducted in Denmark during the 2024-2025 winter season.

设计、环境和参与者：对DAN-RSV试验的预定次要分析，这是一项实用的、开放标签的、个体随机临床试验，于2024-2025年冬季在丹麦进行。

The first participant was enrolled on November 18, 2024.

第一位参与者于2024年11月18日被纳入研究。

Adults aged 60 years or older were eligible for inclusion regardless of comorbidity status.

60岁及以上的成年人，无论共病状况如何，均有资格被纳入研究。

Methods

Participants were randomized 1:1 to receive RSVpreF (n = 65 642) or no vaccine (n = 65 634).

参与者按1:1的比例随机分配接受RSVpreF（n = 65 642）或不接受疫苗（n = 65 634）。

main_outcomes_and_measures

Hospitalization for any cardiorespiratory disease was a prespecified secondary outcome, and hospitalizations for any CVD, heart failure, myocardial infarction, stroke, and atrial fibrillation were prespecified exploratory outcomes.

任何心肺疾病的住院是预先设定的次要结果，任何心血管疾病、心力衰竭、心肌梗死、中风和房颤的住院是预先设定的探索性结果。

Outcomes were assessed from 14 days after booked study visit through May 31, 2025.

从预约的研究访问后14天开始评估结果，直至2025年5月31日。

Vaccine effectiveness was calculated as 1 - incidencerate ratio, expressed as a percentage.

疫苗的有效性计算为1减去发病率比，以百分比表示。

Results

Of 131 276 participants included (mean age, 69.4 [SD, 6.5] years; 50.3% male), 28 662 (21.8%) had preexisting CVD.

在纳入的131,276名参与者中（平均年龄69.4岁[标准差6.5岁]；50.3%为男性），有28,662名（21.8%）存在既往心血管疾病(CVD)。

All-cause cardiorespiratory hospitalization incidencewas lower in the RSVpreF group compared with the control group (26.3 vs 29.2 events per 1000 participant-years [PY]; absolute rate reduction, 2.90 [95% CI, 0.10-5.71] per 1000 PY; vaccine effectiveness, 9.9% [95% CI, 0.3%-18.7%]; P = .04).

与对照组相比，RSVpreF组的全因心肺住院发生率较低（每1000参与者年26.3比29.2事件；绝对率降低2.90 [95%置信区间，0.10-5.71]每1000参与者年；疫苗有效性为9.9% [95%置信区间，0.3%-18.7%]；P = .04）。

There was no significant interaction by baseline CVD status (CVD at baseline: vaccine effectiveness, 5.0% [95% CI, -11.2% to 16.7%]; no CVD at baseline: vaccine effectiveness, 15.2% [95% CI, 2.2%-27.1%]; P = .27 for interaction).

基线时的心血管疾病（CVD）状态没有显著的相互作用（基线时有CVD：疫苗有效性为5.0% [95% 置信区间, -11.2% 至 16.7%]；基线时无CVD：疫苗有效性为15.2% [95% 置信区间, 2.2%-27.1%]；相互作用的P值为.27）。

For the RSVpreF group vs control group, respectively, incidencerates of all-cause cardiovascular hospitalization were 16.4 vs 17.7 events per 1000 PY (vaccine effectiveness, 7.4% [95% CI, -5.5% to 18.8%]; P = .24), and incidencerates of stroke were 3.0 vs 3.8 events per 1000 PY (vaccine effectiveness, 19.4% [95% CI, -8.6% to 40.4%]; P = .14).

对于RSVpreF组与对照组，全因心血管住院的发生率分别为每1000人年16.4例和17.7例（疫苗有效性为7.4% [95% 置信区间, -5.5% 至 18.8%]；P值为.24），中风的发生率分别为每1000人年3.0例和3.8例（疫苗有效性为19.4% [95% 置信区间, -8.6% 至 40.4%]；P值为.14）。

There were also no statistically significant between-group differences for myocardial infarction, heart failure hospitalization, and atrial fibrillation.

在心肌梗死、心力衰竭住院和房颤方面，两组之间也没有统计学上的显著差异。

conclusions_and_relevance

In adults aged 60 years or older, all-cause cardiorespiratory hospitalization was significantly lower with RSVpreF than with no vaccine.

在60岁或60岁以上的成人中，与无疫苗接种相比，使用RSVpreF疫苗的全因心肺住院率显著降低。

The findings suggest potential downstream cardiorespiratory benefits of RSV immunization, although the effect on all-cause cardiovascular hospitalization was not statistically significant.

研究结果表明，RSV免疫接种可能带来潜在的心肺下游益处，尽管其对全因心血管住院的影响在统计学上并不显著。

trial_registration

ClinicalTrials.gov Identifier: NCT06684743.

临床试验注册号：NCT06684743。