High-Dose Versus Standard-Dose Influenza Vaccine in Heart Failure: A Prespecified Analysis of the DANFLU-2 Trial.
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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 Helene, Davidovski Filip Soeskov, 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 C H, 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
Аннотация
METHODS: This was a prespecified analysis of a pragmatic, prospective, individually randomized, open-label trial with registry-based end point-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, any cardiovascular disease, cardio-respiratory disease, and HF, assessed by HF status. Effect of HD-IIV versus SD-IIV in reducing risk of outcomes assessed was expressed as risk ratios.
RESULTS: 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, laboratory-confirmed influenza, cardio-respiratory disease, cardiovascular disease, and HF compared with SD-IIV. In participants with HF, effect estimates were similar: risk ratio for influenza-related hospitalization was 0.48 (95% CI, 0.20-1.06; Pinteraction=0.64), for laboratory-confirmed influenza hospitalization 0.55 (95% CI, 0.29-1.02; Pinteraction=0.59), for cardio-respiratory hospitalization 0.89 (95% CI, 0.77-1.02; Pinteraction=0.34), for cardiovascular hospitalization 0.86 (95% CI, 0.72-1.02; Pinteraction=0.34), and for HF hospitalization 0.82 (95% CI, 0.61-1.11; Pinteraction=0.83). Findings were consistent across HF subgroups by disease duration, recency of hospitalization, most recent NT-proBNP (N-terminal pro-B-type natriuretic peptide), and presence of device therapy.
CONCLUSIONS: 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 cardiovascular hospitalizations compared with SD-IIV, with effect estimates similar across HF status at baseline and HF subgroups.
REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: https://clinicaltrials.gov/study/NCT05517174.