Influenza vaccination reduces the risk of adverse cardiovascular events.The IAMI trial randomly assigned 2571 patients with acute myocardial infarction (AMI) to receive influenza vaccine or saline placebo during their index hospital admission. It was conducted at 30 centers in 8 countries from October 1, 2016 to March 1, 2020. In this post-hoc exploratory sub-study, we compare the trial outcomes in patients receiving early season vaccination (n = 1188) and late season vaccination (n = 1344).The primary endpoint wasthe composite of all-cause death, myocardial infarction (MI), or stent thrombosis at 12 months. Thecumulative incidence of the primary and key secondary endpoints by randomized treatment and early or late vaccination was estimated using the Kaplan-Meier method. In the early vaccinated group, the primary composite endpoint occurred in 36 participants (6.0%) assigned to influenza vaccine and 49 (8.4%) assigned to placebo (HR 0.69; 95% CI 0.45 to 1.07), compared to 31 participants (4.7%) assigned to influenza vaccine and 42 (6.2%) assigned to placebo (HR 0.74; 95% CI 0.47 to 1.18) in the late vaccinated group (P = 0.848 for interaction on HR scale at 1 year). We observed similar estimates for the key secondary endpoints of all-cause death and CV death. There was no statistically significant difference in vaccine effectiveness against adverse cardiovascular events by timing of vaccination. The effect of vaccination on all-cause death at one year was more pronounced in the group receiving early vaccination (HR 0.50; 95% CI, 0.29 to 0.86) compared late vaccination group (HR 0.75; 35% CI, 0.40 to 1.40) but there was no statistically significant difference between these groups (Interaction P = 0.335). In conclusion,there is insufficient evidence from the trial to establish whether there is a difference in efficacy between early and late vaccinationbut regardless of vaccination timing we strongly recommend influenza vaccination in all patients with cardiovascular diseases.

Biosecurity Program The Kirby Institute UNSW Medicine University of New South Wales Sydney New South Wales Australia; Cardiology Unit Department of Medicine Solna Karolinska Institutet and Karolinska University Hospital Stockholm Sweden

Biosecurity Program The Kirby Institute UNSW Medicine University of New South Wales Sydney New South Wales Australia; Programme on Emerging Infections Infectious Diseases Division icddr b Dhaka Bangladesh

Cardiocenter 3rd Faculty of Medicine Charles University Prague and University Hospital Kralovske Vinohrady Prague Czech Republic

Cardiology Heart Centre Department of Public Health and Clinical Medicine Umeå University Umea Sweden

Cardiology Unit Department of Medicine Solna Karolinska Institutet and Karolinska University Hospital Stockholm Sweden

Department of Cardiology Aalborg University Hospital Aalborg Denmark and Department of Clinical Medicine Aalborg University Aalborg Denmark

Department of Cardiology Aarhus University Hospital Aarhus Denmark

Department of Cardiology Jönköping Region Jönköping County and Department of Health Medicine and Caring Linköping University Linköping Sweden

Department of Cardiology Odense University Hospital Odense Denmark

Department of Cardiology Skane University Hospital Clinical Sciences Lund University Lund Sweden

Department of Medical Statistics London School of Hygiene and Tropical Medicine London United Kingdom

Division of Cardiovascular Medicine Department of Clinical Sciences Karolinska Institutet Danderyd University Hospital Stockholm Sweden

Institute of Cardiovascular and Medical Sciences University of Glasgow United Kingdom

International Clinical Research Center St Anne University Hospital and Masaryk University Brno Czech Republic

National Heart Foundation Hospital and Research Institute Dhaka Bangladesh

National Institute of Cardiovascular Diseases Sher e Bangla Nagar Dhaka 1207 Bangladesh

Örebro University Faculty of Health Department of Cardiology Örebro Sweden

Örebro University Faculty of Health Department of Cardiology Örebro Sweden; College of Public Service and Community Solutions Arizona State University Tempe AZ USA; Department of Clinical Medicine Faculty of Health Aarhus University Aarhus Denmark; Department of Clinical Pharmacology Aarhus University Hospital Arhus Denmark; Steno Diabetes Center Aarhus Aarhus University Hospital Aarhus Denmark

Pauls Stradins Clinical University Hospital University of Latvia Riga Latvia

Rigshospitalet University of Copenhagen Copenhagen Denmark

Sahlgrenska University Hospital Gothenburg Sweden and Institute of Medicine Department of molecular and clinical medicine Gothenburg University Gothenburg Sweden

Västmanlands sjukhus Västerås Västerås Sweden

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