High-dose vs. standard-dose inactivated influenza vaccine and cardiovascular outcomes in persons with or without pre-existing atherosclerotic cardiovascular disease: the DANFLU-2 trial
Year: 2025
Type: article
Abstract: BACKGROUND AND AIMS: The aim was to evaluate and compare the relative vaccine effectiveness (rVE) of high-dose (HD-IIV) vs. standard-dose inactivated influenza vaccination (SD-IIV) on respiratory and cardiovascular outcomes in persons with or without pre-existing atherosclerotic cardiovascular disease (ASCVD). METHODS: A prespecified exploratory analysis of a pragmatic, open-label, individually randomized trial conducted in Denmark during three influenza seasons. Adults ≥65 years were randomized 1:1 to HD-IIV or SD-IIV. Baseline and outcome data were collected through nationwide registries. The primary outcome was hospitalization for influenza or pneumonia. Major adverse cardiovascular events (MACE) was defined as a composite of cardiovascular death, hospitalization for myocardial infarction, or hospitalization for stroke. Heterogeneity in rVE among participants with vs. without ASCVD was assessed. RESULTS: The incidence of all outcomes was higher in participants with pre-existing ASCVD (n = 46 825) vs. those without (n = 285 613). rVE was consistent among participants with and without ASCVD (all Pinteraction ≥ .05). The rVE for the primary outcome was 6.87% [95% confidence interval (CI), -2.52 to 15.42] among individuals without ASCVD and 4.71% (95% CI, -11.58 to 18.63) in those with (Pinteraction = .80). For influenza hospitalizations, the rVE was 42.88% (95% CI, 22.07-58.44) vs. 45.73% (95% CI, 16.68-65.16) in those without vs. with ASCVD (Pinteraction = .84). For MACE, the rVE was 4.29% (95% CI, -6.50 to 14.00) in participants without, and 0.30% (95% CI, -17.56 to 15.44) in participants with, pre-existing ASCVD (Pinteraction = .68). CONCLUSIONS: Among individuals ≥65 years, the rVE of HD-IIV vs. SD-IIV against respiratory and cardiovascular outcomes was similar among those with vs. without pre-existing ASCVD.
Source: European Heart Journal
Authors: Manan Pareek, Niklas Dyrby Johansen, Daniel Modin, Matthew M Loiacono, Rebecca C Harris, Marine Dufournet, Carsten Schade Larsen, Lykke Larsen, Lothar Wiese, Michael Dalager-Pedersen, Brian L Claggett, Kira Hyldekær Janstrup, Katja Vu Bartholdy, Katrine Feldballe Bernholm, Julie Inge-Marie Helene Borchsenius, Filip Søskov Davidovski, Lise Witten Davodian, Maria Dons, Lisa Steen Duus, Caroline Espersen, Frederik Holme Fussing, Anne Marie Reimer Jensen, Nino Emanuel Landler, Adam Cadovius Femerling Langhoff, Mats Christian Højbjerg Lassen, Anne Bjerg Nielsen, Camilla Ikast Ottosen, Morten Sengeløv, Kristoffer Grundtvig Skaarup, Scott D Solomon, Martin J Landray, Gunnar H Gislason, Lars Køber, Pradeesh Sivapalan, Cyril Jean-Marie Martel, Jens Ulrik Stæhr Jensen, Tor Biering-Sørensen
Institutions: University of Copenhagen, Copenhagen University Hospital, Gentofte Hospital, Sanofi (United States), Sanofi (France), Aarhus University Hospital, Odense University Hospital, Roskilde Sygehus, Zealand University Hospital, Aalborg University Hospital, Aalborg University, Brigham and Women's Hospital, Harvard University, University of Oxford, Rigshospitalet, Statens Serum Institut, Steno Diabetes Center Copenhagen
Language: English
Subfield: Epidemiology
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $5,922
Funders: Sanofi, Sanofi Australia
OpenAlex ID: W4413845582