Effect of RSV vaccine in older adults with atrial fibrillation: a prespecified analysis of the DAN-RSV trial
Year: 2026
Type: article
Abstract: AIMS: Atrial fibrillation (AF) is a risk factor for respiratory syncytial virus (RSV)-related adverse cardiac events. This prespecified analysis of the DAN-RSV trial investigated RSVpreF vaccine effectiveness (VE) against respiratory and cardiovascular outcomes among older adults with and without AF. METHODS AND RESULTS: DAN-RSV was a pragmatic, open-label, individually randomized trial in Denmark during the 2024/2025 winter season. Adults ≥60 years were randomly assigned 1:1 to RSVpreF vaccine or no vaccine. Baseline and endpoint data were obtained from nationwide health registries. The primary endpoint was hospitalization for RSV-related respiratory tract disease, occurring 14 days after study visit until May 31, 2025. Prespecified respiratory and cardiovascular endpoints were assessed by AF status. Among 131,276 participants, 10,126 (7.7%) had a history of AF (mean age 73.2 ± 6.9 years, 30.4% female). AF participants had higher event rates compared with non-AF participants. RSVpreF vaccine lowered the incidence of the primary endpoint with no evidence of effect modification by AF status (AF: VE 80.6% (95%CI -84.7 to 99.6), no AF: VE 84.6% (95%CI 32.3 to 98.3), p-value for interaction >0.99). RSVpreF vaccine was further associated with a lower incidence of all-cause respiratory tract disease hospitalization (AF: VE 25.7% (95%CI -16.9 to 46.1), no AF: VE 13.0% (95%CI -3.3 to 27.8)) and RSV-related and overall cardio-respiratory disease hospitalization with no evidence of effect modification by AF status (p-value for interaction ≥0.45 for all). RSVpreF vaccine was not significantly associated with AF or stroke hospitalizations regardless of AF status (p-value for interaction≥0.34 for all). CONCLUSIONS: In older adults, RSVpreF vaccine was associated with a lower incidence of RSV-related and all-cause respiratory tract disease hospitalizations, as well as RSV-related and all-cause cardio-respiratory disease hospitalizations, with no evidence of effect modification by AF status.
Authors: Caroline Espersen, Mats C H Lassen, Niklas Dyrby Johansen, Sine H Christensen, Negar Aliabadi, Kristoffer Grundtvig Skaarup, Daniel Modin, Kira Hyldekær Janstrup, Brian L Claggett, Carsten Schade Larsen, Lykke Larsen, Lothar Wiese, Michael Dalager-Pedersen, Matias G Lindholm, Anne Marie R Jensen, Maria Dons, Katrine F Bernholm, Filip S Davidovski, Lisa S Duus, Camilla I Ottosen, Anne B Nielsen, Julie H Borchsenius, Guldas Köse, Frederik H Fussing, Manan Pareek, Lars Køber, Scott D Solomon, Jens Ulrik Stæhr Jensen, Cyril Jean-Marie Martel, Bradford D Gessner, Claudia Schwarz, Elisa Gonzalez, Mette Skovdal, Pingping Zhang, Elizabeth Begier, Tor Biering-Sørensen
Institutions: University of Copenhagen, Copenhagen University Hospital, Gentofte Hospital, Pfizer (United States), Brigham and Women's Hospital, Harvard University, Aarhus University Hospital, Odense University Hospital, Zealand University Hospital, Aalborg University Hospital, Rigshospitalet, Statens Serum Institut, Steno Diabetes Center Copenhagen
Language: English
Subfield: Epidemiology
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $3,792
Award: G8547927097
OpenAlex ID: W7165142832