Ole Fröbert1, Matthias Götberg2, David Erlinge2, Zubair Akhtar3, Evald H Christiansen4, Chandini R MacIntyre5, Keith G Oldroyd6, Zuzana Motovska7, Andrejs Erglis8, Rasmus Moer9, Ota Hlinomaz10, Lars Jakobsen4, Thomas Engstrøm11, Lisette O Jensen12, Christian O Fallesen12, Svend E Jensen13, Oskar Angerås14, Fredrik Calais1, Amra Kåregren15, Jörg Lauermann16, Arash Mokhtari2, Johan Nilsson17, Jonas Persson18, Per Stalby19, Abu K M M Islam20, Afzalur Rahman20, Fazila Malik21, Sohel Choudhury21, Timothy Collier22, Stuart J Pocock22, John Pernow23. 1. Örebro University, Faculty of Health, Department of Cardiology, Sweden (O.F., F.C.). 2. Department of Cardiology, Skane University Hospital, Clinical Sciences, Lund University, Sweden (M.G., D.E., A.M.). 3. International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka (Z.A.). 4. Department of Cardiology, Aarhus University Hospital, Denmark (E.H.C., L.J.). 5. The Kirby Institute, UNSW Medicine, University of New South Wales, Sydney, Australia (C.R.M.). 6. British Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, United Kingdom, and West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, Glasgow, United Kingdom (K.G.O.). 7. Cardiocenter, Third Faculty of Medicine, Charles University, and University Hospital Kralovske Vinohrady, Prague, Czech Republic (Z.M.). 8. Pauls Stradins Clinical University Hospital, University of Latvia, Riga (A.E.). 9. LHL-sykehuset Gardermoen, Oslo, Norway (R.M.). 10. International clinical research center, St. Anne University Hospital and Masaryk University, Brno, Czech Republic (O.H.). 11. Rigshospitalet, University of Copenhagen, Denmark (T.E.). 12. Department of Cardiology, Odense University Hospital, Denmark (L.O.J., C.O.F.). 13. Department of Cardiology, Aalborg University Hospital, and Department of Clinical Medicine, Aalborg University, Denmark (S.E.J.). 14. Sahlgrenska University Hospital and Institute of Medicine, Department of molecular and clinical medicine, Gothenburg University, Sweden (O.A.). 15. Västmanlands sjukhus Västerås, Sweden (A.K.). 16. Department of Cardiology, Jönköping, Region Jönköping County, and Department of Health, Medicine and Caring, Linköping University, Sweden (J.L.). 17. Cardiology, Heart Centre, Department of Public Health and Clinical Medicine, Umeå University, Sweden (J.N.). 18. Division of Cardiovascular Medicine, Department of Clinical Sciences, Karolinska Institutet, Danderyd University Hospital, Stockholm, Sweden (J. Persson). 19. Department of Cardiology, Karlstad Central Hospital, Sweden (P.S.). 20. National Institute of Cardiovascular Diseases, Sher-e-Bangla Nagar, Dhaka, Bangladesh (A.K.K.M.I., A.R.). 21. National Heart Foundation Hospital and Research Institute, Dhaka, Bangladesh (F.M., S.C.). 22. Department of Medical Statistics, London School of Hygiene and Tropical Medicine, United Kingdom (T.C., S.J.P.). 23. Cardiology Unit, Department of Medicine Solna, Karolinska Institutet and Karolinska University Hospital, Stockholm, Sweden (J. Pernow).
Abstract
BACKGROUND: Observational and small, randomized studies suggest that influenza vaccine may reduce future cardiovascular events in patients with cardiovascular disease. METHODS: We conducted an investigator-initiated, randomized, double-blind trial to compare inactivated influenza vaccine with saline placebo administered shortly after myocardial infarction (MI; 99.7% of patients) or high-risk stable coronary heart disease (0.3%). The primary end point was the composite of all-cause death, MI, or stent thrombosis at 12 months. A hierarchical testing strategy was used for the key secondary end points: all-cause death, cardiovascular death, MI, and stent thrombosis. RESULTS: Because of the COVID-19 pandemic, the data safety and monitoring board recommended to halt the trial before attaining the prespecified sample size. Between October 1, 2016, and March 1, 2020, 2571 participants were randomized at 30 centers across 8 countries. Participants assigned to influenza vaccine totaled 1290 and individuals assigned to placebo equaled 1281; of these, 2532 received the study treatment (1272 influenza vaccine and 1260 placebo) and were included in the modified intention to treat analysis. Over the 12-month follow-up, the primary outcome occurred in 67 participants (5.3%) assigned influenza vaccine and 91 participants (7.2%) assigned placebo (hazard ratio, 0.72 [95% CI, 0.52-0.99]; P=0.040). Rates of all-cause death were 2.9% and 4.9% (hazard ratio, 0.59 [95% CI, 0.39-0.89]; P=0.010), rates of cardiovascular death were 2.7% and 4.5%, (hazard ratio, 0.59 [95% CI, 0.39-0.90]; P=0.014), and rates of MI were 2.0% and 2.4% (hazard ratio, 0.86 [95% CI, 0.50-1.46]; P=0.57) in the influenza vaccine and placebo groups, respectively. CONCLUSIONS: Influenza vaccination early after an MI or in high-risk coronary heart disease resulted in a lower risk of a composite of all-cause death, MI, or stent thrombosis, and a lower risk of all-cause death and cardiovascular death, as well, at 12 months compared with placebo. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02831608.
BACKGROUND: Observational and small, randomized studies suggest that influenza vaccine may reduce future cardiovascular events in patients with cardiovascular disease. METHODS: We conducted an investigator-initiated, randomized, double-blind trial to compare inactivated influenza vaccine with saline placebo administered shortly after myocardial infarction (MI; 99.7% of patients) or high-risk stable coronary heart disease (0.3%). The primary end point was the composite of all-cause death, MI, or stent thrombosis at 12 months. A hierarchical testing strategy was used for the key secondary end points: all-cause death, cardiovascular death, MI, and stent thrombosis. RESULTS: Because of the COVID-19 pandemic, the data safety and monitoring board recommended to halt the trial before attaining the prespecified sample size. Between October 1, 2016, and March 1, 2020, 2571 participants were randomized at 30 centers across 8 countries. Participants assigned to influenza vaccine totaled 1290 and individuals assigned to placebo equaled 1281; of these, 2532 received the study treatment (1272 influenza vaccine and 1260 placebo) and were included in the modified intention to treat analysis. Over the 12-month follow-up, the primary outcome occurred in 67 participants (5.3%) assigned influenza vaccine and 91 participants (7.2%) assigned placebo (hazard ratio, 0.72 [95% CI, 0.52-0.99]; P=0.040). Rates of all-cause death were 2.9% and 4.9% (hazard ratio, 0.59 [95% CI, 0.39-0.89]; P=0.010), rates of cardiovascular death were 2.7% and 4.5%, (hazard ratio, 0.59 [95% CI, 0.39-0.90]; P=0.014), and rates of MI were 2.0% and 2.4% (hazard ratio, 0.86 [95% CI, 0.50-1.46]; P=0.57) in the influenza vaccine and placebo groups, respectively. CONCLUSIONS: Influenza vaccination early after an MI or in high-risk coronary heart disease resulted in a lower risk of a composite of all-cause death, MI, or stent thrombosis, and a lower risk of all-cause death and cardiovascular death, as well, at 12 months compared with placebo. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02831608.
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