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High Dose versus Standard Dose Influenza Vaccine in Patients With High Risk Cardiovascular Disease: Results From the Invested Trial

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Author Block: Orly Vardeny, Minneapolis VA & Univ of Minnesota, Minneapolis, MN; KyungMann Kim, Univ of Wisconsin-Madison, Madison, WI; Jacob A Udell, Univ of Wisconsin-Madison, Madison, WI, Toronto, ON, Canada; Jacob Joseph, VA Boston Brigham Women's Hosp, Boston, MA; Adrian F Hernandez, Duke Clinical Res Inst, Durham, NC; H Keipp Talbot, Vanderbilt Univ, Nashville, TN; Michael E Farkouh, Peter Munk Cardiac Ctr, Toronto, ON, Canada; Lawton S Cooper, NHLBI, Silver Spring, MD; Scott Solomon, Brigham and Women's Hosp, Boston, MA
Disclosure Block: O.Vardeny: Honoraria; Modest; Novartis , Amgen, Other Research Support; Modest; AstraZeneca. K.Kim: Other; Modest; Bayer, Other; Significant; AstraZeneca, Astellas, Idorsia, Other Research Support; Significant; sanofi pasteur. J.A.Udell: Honoraria; Modest; Boehringer-Ingelheim, Novartis, Sanofi, Research Grant; Modest; Boehringer-Ingelheim, Sanofi. J.Joseph: Research Grant; Significant; Amgen, Novartis, Otsuka, Kowa. A.F.Hernandez: Honoraria; Modest; Bayer, Boston Scientific, Amgen, Cytokinetics, Myokardia, Relypsa, Research Grant; Modest; AstraZeneca, Merck, Novartis, American Regent, Verily, GlaxoSmithKline. H.Talbot: None. M.E.Farkouh: Research Grant; Significant; Novo Nordisk, Amgen. L.S.Cooper: None. S.Solomon: Other; Modest; Akros, Alnylam, Amgen, Arena, AstraZeneca, Bayer, BMS, Cardior, Corvia, Cytokinetics, Daiichi-Sankyo, Gilead, GSK, Ironwood, Merck, Myokardia, Novartis, Roche, Takeda, Theracos, Quantum Genetics, C, Research Grant; Significant; Alnylam, Amgen, AstraZeneca, Bellerophon, Bayer, BMS, Celladon, Cytokinetics, Eidos, Gilead, GSK, Ionis, Lone Star Heart, Mesoblast, MyoKardia, Neurotronik, NIH/NHLBI, Novartis, Respicardia, Sanofi Pa.
Background: Influenza is temporally associated with cardiopulmonary morbidity and mortality among those with underlying cardiovascular disease. Influenza vaccination reduces adverse clinical outcomes and is recommended annually. Individuals with cardiovascular disease often fail to mount a robust immune response to influenza vaccine, which may reduce vaccine effectiveness. Whether high dose influenza vaccine, currently approved for people age 65 or older, reduces the risk of cardiopulmonary events compared to a standard dose vaccine is unknown. Methods: INfluenza Vaccine to Effectively Stop cardio Thoracic Events and Decompensated heart failure (INVESTED) is a pragmatic, randomized, double-blind, active-controlled trial designed to test the efficacy of high-dose trivalent versus standard-dose quadrivalent influenza vaccine in patients with a history of recent hospitalization for acute myocardial infarction (MI) or heart failure (HF). Eligible patients also needed to fulfill an enrichment criterion (age ≥65, current or historical LVEF < 40%, diabetes mellitus, BMI ≥30, history of renal impairment with eGFR < 60 for at least 2 readings in the past year, ischemic stroke, peripheral artery disease, current tobacco use, or additional MI or HF event). Participants were randomized at enrollment to high-dose or standard-dose influenza vaccine and could re-enroll for up to three influenza seasons. The primary outcome is a composite of all-cause mortality or hospitalization for a cardiovascular or pulmonary cause according to a modified intent-to-treat analysis of outcomes accrued in each enrolling season, analyzed in a Cox proportional hazards model stratified by season. Results: A total of 5260 participants (mean age 65.5 ±12.6 years, 72% male, 63% with inclusion of HF) were enrolled during the 2016/2017 (N=494), 2017/2018 (N=2506), and 2018/2019 (N=2264) influenza seasons and randomized to high dose (N=2630) or standard dose (N=2630) influenza vaccine, with 7154 total vaccination-years. Baseline characteristics are shown in the table. Primary and secondary results according to treatment arm will be presented. Conclusions: INVESTED is the largest study to investigate whether high-dose influenza vaccine is superior to standard-dose influenza vaccine in reducing all-cause death or cardiopulmonary hospitalizations in a high-risk cardiovascular population. Trial results have the potential to inform health care policy regarding vaccination of high-risk individuals and reducing influenza-related complications.