tetano
Editor, Senior Moderator
Circ Cardiovasc Qual Outcomes
. 2024 Aug 31.
doi: 10.1161/CIRCOUTCOMES.124.011496. Online ahead of print. Relative Effectiveness of High-Dose vs. Standard-Dose Quadrivalent Influenza Vaccine in Older Adults with Cardiovascular Disease: A Prespecified Analysis of the DANFLU-1 Randomized Clinical Trial
Jacob Christensen[SUP] 1 [/SUP], Niklas Dyrby Johansen[SUP] 1 [/SUP], Daniel Modin[SUP] 1 [/SUP], Kira Hyldekaer Janstrup[SUP] 1 [/SUP], Joshua Nealon[SUP] 2 [/SUP], Sandrine I Samson[SUP] 2 [/SUP], Matthew M Loiacono[SUP] 3 [/SUP], Rebecca Harris[SUP] 4 [/SUP], Carsten Schade Larsen[SUP] 5 [/SUP], Anne Marie Reimer Jensen[SUP] 1 [/SUP], Nino E Landler[SUP] 1 [/SUP], Brian L Claggett[SUP] 6 [/SUP], Scott D Solomon[SUP] 7 [/SUP], Gunnar H Gislason[SUP] 8 [/SUP], Lars Køber[SUP] 9 [/SUP], Martin J Landray[SUP] 10 [/SUP], Pradeesh Sivapalan[SUP] 11 [/SUP], Jens Ulrik Stæhr Jensen[SUP] 11 [/SUP], Tor Biering-Sørensen[SUP] 12 [/SUP]
Affiliations
Background: Influenza vaccination reduces the risk of adverse outcomes in patients with cardiovascular disease (CVD). We sought to evaluate whether the presence of CVD modified the relative effectiveness of high-dose (QIV-HD) vs. standard-dose (QIV-SD) quadrivalent influenza vaccine in this prespecified analysis of the DANFLU-1 trial. Methods: DANFLU-1 was a pragmatic, open-label, randomized feasibility trial of QIV-HD vs. QIV-SD in adults aged 65-79 years during the 2021/2022 influenza season in Denmark. Vaccines were allocated in a 1:1 ratio. Baseline and follow-up data regarding diagnoses and mortality were obtained from Danish national registers. The trial is registered at Clinicaltrials.gov: NCT05048589. The CVDs assessed included heart failure (HF), ischemic heart disease (IHD), atrial fibrillation, and a combined group denoted "chronic CVD" consisting of the aforementioned diseases, among others. Prespecified outcomes included hospitalizations for pneumonia or influenza, respiratory disease, CVD, cardiorespiratory disease, all-cause hospitalizations, and mortality. Effect modification was tested using interaction terms. Results: The final study population included 12,477 participants (mean age 71.7±3.9 years, 5,877 (47.1%) female), of whom 2,540 (20.4%) had chronic CVD. QIV-HD vs. QIV-SD was associated with a lower incidence of hospitalizations for pneumonia or influenza (IRR 0.30 (95%-CI 0.14-0.64)) and all-cause mortality (IRR 0.51 (0.30-0.86)) regardless of chronic CVD (p for interaction=0.57 and 0.49, respectively). The relative effectiveness of QIV-HD vs. QIV-SD against all-cause hospitalizations was modified in participants with chronic CVD (Overall: IRR 0.87 (0.76-0.99); no chronic CVD: 0.79 (0.67-0.92); chronic CVD: 1.11 (0.88-1.39); p for interaction=0.026). No other effect modification was observed by the presence of chronic CVD, HF, IHD, or atrial fibrillation. Conclusions: The relative effectiveness of QIV-HD vs. QIV-SD was consistent against hospitalizations for pneumonia or influenza and all-cause mortality regardless of chronic CVD. However, the relative effectiveness against all-cause hospitalizations was modified by the presence of chronic CVD. These results should be considered hypothesis-generating.
. 2024 Aug 31.
doi: 10.1161/CIRCOUTCOMES.124.011496. Online ahead of print. Relative Effectiveness of High-Dose vs. Standard-Dose Quadrivalent Influenza Vaccine in Older Adults with Cardiovascular Disease: A Prespecified Analysis of the DANFLU-1 Randomized Clinical Trial
Jacob Christensen[SUP] 1 [/SUP], Niklas Dyrby Johansen[SUP] 1 [/SUP], Daniel Modin[SUP] 1 [/SUP], Kira Hyldekaer Janstrup[SUP] 1 [/SUP], Joshua Nealon[SUP] 2 [/SUP], Sandrine I Samson[SUP] 2 [/SUP], Matthew M Loiacono[SUP] 3 [/SUP], Rebecca Harris[SUP] 4 [/SUP], Carsten Schade Larsen[SUP] 5 [/SUP], Anne Marie Reimer Jensen[SUP] 1 [/SUP], Nino E Landler[SUP] 1 [/SUP], Brian L Claggett[SUP] 6 [/SUP], Scott D Solomon[SUP] 7 [/SUP], Gunnar H Gislason[SUP] 8 [/SUP], Lars Køber[SUP] 9 [/SUP], Martin J Landray[SUP] 10 [/SUP], Pradeesh Sivapalan[SUP] 11 [/SUP], Jens Ulrik Stæhr Jensen[SUP] 11 [/SUP], Tor Biering-Sørensen[SUP] 12 [/SUP]
Affiliations
- PMID: 39215646
- DOI: 10.1161/CIRCOUTCOMES.124.011496
Background: Influenza vaccination reduces the risk of adverse outcomes in patients with cardiovascular disease (CVD). We sought to evaluate whether the presence of CVD modified the relative effectiveness of high-dose (QIV-HD) vs. standard-dose (QIV-SD) quadrivalent influenza vaccine in this prespecified analysis of the DANFLU-1 trial. Methods: DANFLU-1 was a pragmatic, open-label, randomized feasibility trial of QIV-HD vs. QIV-SD in adults aged 65-79 years during the 2021/2022 influenza season in Denmark. Vaccines were allocated in a 1:1 ratio. Baseline and follow-up data regarding diagnoses and mortality were obtained from Danish national registers. The trial is registered at Clinicaltrials.gov: NCT05048589. The CVDs assessed included heart failure (HF), ischemic heart disease (IHD), atrial fibrillation, and a combined group denoted "chronic CVD" consisting of the aforementioned diseases, among others. Prespecified outcomes included hospitalizations for pneumonia or influenza, respiratory disease, CVD, cardiorespiratory disease, all-cause hospitalizations, and mortality. Effect modification was tested using interaction terms. Results: The final study population included 12,477 participants (mean age 71.7±3.9 years, 5,877 (47.1%) female), of whom 2,540 (20.4%) had chronic CVD. QIV-HD vs. QIV-SD was associated with a lower incidence of hospitalizations for pneumonia or influenza (IRR 0.30 (95%-CI 0.14-0.64)) and all-cause mortality (IRR 0.51 (0.30-0.86)) regardless of chronic CVD (p for interaction=0.57 and 0.49, respectively). The relative effectiveness of QIV-HD vs. QIV-SD against all-cause hospitalizations was modified in participants with chronic CVD (Overall: IRR 0.87 (0.76-0.99); no chronic CVD: 0.79 (0.67-0.92); chronic CVD: 1.11 (0.88-1.39); p for interaction=0.026). No other effect modification was observed by the presence of chronic CVD, HF, IHD, or atrial fibrillation. Conclusions: The relative effectiveness of QIV-HD vs. QIV-SD was consistent against hospitalizations for pneumonia or influenza and all-cause mortality regardless of chronic CVD. However, the relative effectiveness against all-cause hospitalizations was modified by the presence of chronic CVD. These results should be considered hypothesis-generating.