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. 2025 Sep 25.
doi: 10.1002/ehf2.15432. Online ahead of print. Simultaneous vaccination against influenza and respiratory syncytial virus in high-risk heart failure patients
Jan Biegus 1 2 , Leszek Szenborn 3 , Michał Tkaczyszyn 1 2 , Robert Zymlinski 1 2 , Gad Cotter 4 5 , Michał Zakliczynski 1 2 , Krzysztof Reczuch 1 2 , Mateusz Guzik 1 2 , Szymon Urban 6 , Marta Rosiek-Biegus 7 , Berenika Jankowiak 1 2 , Gracjan Iwanek 1 2 , Marta Wleklik 8 , Marat Fudim 9 10 , Piotr Ponikowski 1 2
Affiliations
Background: There is a scarcity of prospective data on the impact of available vaccinations against respiratory viruses on hard clinical endpoints in patients with heart failure (HF).
Aims: We investigated whether, in the population of high-risk HF patients, simultaneous vaccination against influenza and respiratory syncytial virus (RSV) improves outcomes during the subsequent infection season.
Methods: We conducted a prospective, randomized, single-centre, open-label study in which patients with high-risk HF were randomized 1:1 to simultaneous influenza and RSV vaccination or standard of care (SOC). The primary composite endpoint comprised all-cause death, HF hospitalization (HFH) or clinical signs/symptoms of infection within a 6 month follow-up period (regular structured telephone interview). Secondary endpoints were components of the composite primary endpoint.
Results: Two hundred twenty patients were randomized. During the follow-up period, the primary endpoint occurred in 59% of patients in the vaccination group versus 75% in the SOC group [hazard ratio (HR) 0.66, 95% confidence interval (CI) 0.48-0.92, P = 0.01]. Regarding the secondary endpoint analyses, during 6 month follow-up, 3% in the vaccination group died compared with 5% of patients in the SOC arm (HR 0.50, 95% CI 0.12 1.99, P = 0.32), and 18% versus 16% of study participants were hospitalized for HF in the two study arms, respectively (HR 0.86, 95% CI 0.45-1.62, P = 0.64). Infection occurred in 53% of vaccinated patients compared with 68% in SOC (HR 0.68, 95% CI 0.48-0.96, P = 0.03).
Conclusions: In the population of high-risk HF, simultaneous vaccination against influenza and RSV reduced the incidence of the primary outcome. The effect was driven by a significant reduction in infections.
Keywords: heart failure; influenza; outcomes; respiratory syncytial virus; vaccination.
. 2025 Sep 25.
doi: 10.1002/ehf2.15432. Online ahead of print. Simultaneous vaccination against influenza and respiratory syncytial virus in high-risk heart failure patients
Jan Biegus 1 2 , Leszek Szenborn 3 , Michał Tkaczyszyn 1 2 , Robert Zymlinski 1 2 , Gad Cotter 4 5 , Michał Zakliczynski 1 2 , Krzysztof Reczuch 1 2 , Mateusz Guzik 1 2 , Szymon Urban 6 , Marta Rosiek-Biegus 7 , Berenika Jankowiak 1 2 , Gracjan Iwanek 1 2 , Marta Wleklik 8 , Marat Fudim 9 10 , Piotr Ponikowski 1 2
Affiliations
- PMID: 40998567
- DOI: 10.1002/ehf2.15432
Background: There is a scarcity of prospective data on the impact of available vaccinations against respiratory viruses on hard clinical endpoints in patients with heart failure (HF).
Aims: We investigated whether, in the population of high-risk HF patients, simultaneous vaccination against influenza and respiratory syncytial virus (RSV) improves outcomes during the subsequent infection season.
Methods: We conducted a prospective, randomized, single-centre, open-label study in which patients with high-risk HF were randomized 1:1 to simultaneous influenza and RSV vaccination or standard of care (SOC). The primary composite endpoint comprised all-cause death, HF hospitalization (HFH) or clinical signs/symptoms of infection within a 6 month follow-up period (regular structured telephone interview). Secondary endpoints were components of the composite primary endpoint.
Results: Two hundred twenty patients were randomized. During the follow-up period, the primary endpoint occurred in 59% of patients in the vaccination group versus 75% in the SOC group [hazard ratio (HR) 0.66, 95% confidence interval (CI) 0.48-0.92, P = 0.01]. Regarding the secondary endpoint analyses, during 6 month follow-up, 3% in the vaccination group died compared with 5% of patients in the SOC arm (HR 0.50, 95% CI 0.12 1.99, P = 0.32), and 18% versus 16% of study participants were hospitalized for HF in the two study arms, respectively (HR 0.86, 95% CI 0.45-1.62, P = 0.64). Infection occurred in 53% of vaccinated patients compared with 68% in SOC (HR 0.68, 95% CI 0.48-0.96, P = 0.03).
Conclusions: In the population of high-risk HF, simultaneous vaccination against influenza and RSV reduced the incidence of the primary outcome. The effect was driven by a significant reduction in infections.
Keywords: heart failure; influenza; outcomes; respiratory syncytial virus; vaccination.