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Influenza Vaccination after Myocardial Infarction : A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial

Fröbert, Ole, 1964- (author)
Örebro universitet,Institutionen för medicinska vetenskaper,Faculty of Health, Department of Cardiology, Sweden (O.F., Örebro University,Orebro Univ, Sweden
Götberg, Matthias (author)
Department of Cardiology, Skåne University Hospital, Clinical Sciences, Lund University, Lund, Sweden,Lund Univ, Sweden
Erlinge, David (author)
Department of Cardiology, Skåne University Hospital, Clinical Sciences, Lund University, Lund, Sweden,Lund Univ, Sweden
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Akhtar, Zubair (author)
International Centre for Diarrhoeal Disease Research, Bangladesh, (icddr,b) Dhaka, Bangladesh,Int Ctr Diarrhoea Dis Res, Bangladesh
Christiansen, Evald H. (author)
Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark,Aarhus Univ Hosp, Denmark
MacIntyre, Chandini R. (author)
The Kirby Institute, UNSW Medicine, University of New South Wales, Sydney, New South Wales, Australia,Kirby Institute, UNSW Medicine, University of New South Wales, Sydney, Canada
Oldroyd, Keith G. (author)
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.),Univ Glasgow, Scotland; Golden Jubilee Natl Hosp, Scotland
Motovska, Zuzana (author)
Cardiocenter, Third Faculty of Medicine, Charles University, Prague, Czech Republic and University Hospital Kralovske Vinohrady, Prague, Czech Republic,Cardiocenter, Third Faculty of Medicine, Charles University, University Hospital Kralovske Vinohrady, Czech Republic (Z.M.), Prague, United States,Charles Univ Prague, Czech Republic; Univ Hosp Kralovske Vinohrady, Czech Republic
Erglis, Andrejs (author)
Pauls Stradins Clinical University Hospital, University of Latvia, Riga, Latvia,Univ Latvia, Latvia
Moer, Rasmus (author)
LHL-sykehuset Gardermoen, Oslo, Norway
Hlinomaz, Ota (author)
International clinical research center, St. Anne University Hospital and Masaryk University, Czech Republic (O.H.), Brno,St Anne Univ Hosp, Czech Republic; Masaryk Univ, Czech Republic
Jakobsen, Lars (author)
Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark,Aarhus Univ Hosp, Denmark
Engstrøm, Thomas (author)
Rigshospitalet, University of Copenhagen, Copenhagen, Denmark,Univ Copenhagen, Denmark
Jensen, Lisette O. (author)
Department of Cardiology, Odense University Hospital, Odense, Denmark,Department of Cardiology, Odense University Hospital, C.O.F.),Odense Univ Hosp, Denmark
Fallesen, Christian O. (author)
Department of Cardiology, Odense University Hospital, Odense, Denmark,Department of Cardiology, Odense University Hospital, C.O.F.),Odense Univ Hosp, Denmark
Jensen, Svend E. (author)
Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark and Department of Clinical Medicine, Aalborg University, Aalborg, Denmark,Aalborg Univ, Denmark; Aalborg Univ, Denmark
Angerås, Oskar, 1976 (author)
Gothenburg University,Göteborgs universitet,Institutionen för medicin, avdelningen för molekylär och klinisk medicin,Institute of Medicine, Department of Molecular and Clinical Medicine
Calais, Fredrik, 1971- (author)
Örebro universitet,Institutionen för medicinska vetenskaper,Region Örebro län,Faculty of Health, Department of Cardiology, Sweden (O.F., Örebro University,Orebro Univ, Sweden
Kåregren, Amra (author)
Västmanlands sjukhus Västerås, Västerås, Sweden
Lauermann, Jorg (author)
Linköpings universitet,Institutionen för hälsa, medicin och vård,Medicinska fakulteten,Dept Cardiol, Jonkoping, Sweden
Mokhtari, Arash (author)
Department of Cardiology, Skane University Hospital, Clinical Sciences, Lund University, Lund, Sweden,Lund Univ, Sweden
Nilsson, Johan (author)
Umeå universitet,Kardiologi,Umea Univ, Sweden
Persson, Jonas (author)
Karolinska Institutet,Karolinska Inst, Sweden
Stalby, Per (author)
Department of Cardiology, Karlstad Central Hospital, Karlstad, Sweden,Karlstad Cent Hosp, Sweden
Islam, Abu K. M. M. (author)
National Institute of Cardiovascular Diseases, Sher-e-Bangla Nagar, Dhaka, Bangladesh,Natl Inst Cardiovasc Dis, Bangladesh
Rahman, Afzalur (author)
National Institute of Cardiovascular Diseases, Sher-e-Bangla Nagar, Dhaka, Bangladesh,Natl Inst Cardiovasc Dis, Bangladesh
Malik, Fazila (author)
National Heart Foundation Hospital and Research Institute, Dhaka, Bangladesh,Natl Heart Fdn Hosp & Res Inst, Bangladesh
Choudhury, Sohel (author)
National Heart Foundation Hospital and Research Institute, Dhaka, Bangladesh,Natl Heart Fdn Hosp & Res Inst, Bangladesh
Collier, Timothy (author)
Department of Medical Statistics, London School of Hygiene and Tropical Medicine, United Kingdom (T.C.,London Sch Hyg & Trop Med, England
Pocock, Stuart J. (author)
Department of Medical Statistics, London School of Hygiene and Tropical Medicine, United Kingdom (T.C.,London Sch Hyg & Trop Med, England
Pernow, John (author)
Karolinska Institutet,Karolinska Inst, Sweden; Karolinska Univ Hosp, Sweden
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 (creator_code:org_t)
Lippincott Williams & Wilkins, 2021
2021
English.
In: Circulation. - : Lippincott Williams & Wilkins. - 0009-7322 .- 1524-4539. ; 144:18, s. 1476-1484
  • Journal article (peer-reviewed)
Abstract Subject headings
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  • 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 endpoint was the composite of all-cause death, MI, or stent thrombosis at 12 months. A hierarchical testing strategy was used for the key secondary endpoints: all-cause death, cardiovascular death, MI, and stent thrombosis.Results: Due to the Covid-19 pandemic, the data safety and monitoring board decided 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 eight countries; 1290 assigned to influenza vaccine and 1281 to placebo. 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% confidence interval, 0.52 to 0.99; P=0.040). Rates of all-cause death were 2.9% and 4.9% (hazard ratio, 0.59; 0.39 to 0.89; P=0.010), of cardiovascular death 2.7% and 4.5%, (hazard ratio, 0.59; 0.39 to 0.90; P=0.014), and of MI 2.0% and 2.4% (hazard ratio, 0.86; 0.50 to 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, as well as a lower risk of all-cause death and cardiovascular death at 12 months compared with placebo.Clinical Trial Registration: URL: http://www.clinicaltrials.gov Unique identifier: NCT02831608.

Subject headings

MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Kardiologi (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Cardiac and Cardiovascular Systems (hsv//eng)

Keyword

influenza vaccines
myocardial infarction
randomized controlled trial

Publication and Content Type

ref (subject category)
art (subject category)

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