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

J 2021

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

FROBERT, O., M. GOTBERG, D. ERLINGE, Z. AKHTAR, E. H. CHRISTIANSEN et. al.

Basic information

Original name

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

Authors

FROBERT, O. (guarantor), M. GOTBERG, D. ERLINGE, Z. AKHTAR, E. H. CHRISTIANSEN, C. R. MACINTYRE, K. G. OLDROYD, Z. MOTOVSKA, A. ERGLIS, R. MOER, Ota HLINOMAZ (203 Czech Republic, belonging to the institution), L. JAKOBSEN, T. ENGSTROM, L. O. JENSEN, C. O. FALLESEN, S. E. JENSEN, O. ANGERAS, F. CALAIS, A. KAREGREN, J. LAUERMANN, A. MOKHTARI, J. NILSSON, J. PERSSON, P. STALBY, A. K. M. M. ISLAM, A. RAHMAN, F. MALIK, S. CHOUDHURY, T. COLLIER, S. J. POCOCK and J. PERNOW

Edition

Circulation, Philadelphia, Lippincott Williams Wilkins, 2021, 0009-7322

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30201 Cardiac and Cardiovascular systems

Country of publisher

United States of America

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

URL

Impact factor

Impact factor: 39.918

RIV identification code

RIV/00216224:14110/21:00124147

Organization unit

Faculty of Medicine

DOI

http://dx.doi.org/10.1161/CIRCULATIONAHA.121.057042

UT WoS

000747313100007

Keywords in English

influenza vaccines; myocardial infarction; randomized controlled trial

Abstract

V originále

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.

Citovat

FROBERT, O., M. GOTBERG, D. ERLINGE, Z. AKHTAR, E. H. CHRISTIANSEN, C. R. MACINTYRE, K. G. OLDROYD, Z. MOTOVSKA, A. ERGLIS, R. MOER, Ota HLINOMAZ, L. JAKOBSEN, T. ENGSTROM, L. O. JENSEN, C. O. FALLESEN, S. E. JENSEN, O. ANGERAS, F. CALAIS, A. KAREGREN, J. LAUERMANN, A. MOKHTARI, J. NILSSON, J. PERSSON, P. STALBY, A. K. M. M. ISLAM, A. RAHMAN, F. MALIK, S. CHOUDHURY, T. COLLIER, S. J. POCOCK and J. PERNOW. Influenza Vaccination After Myocardial Infarction: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial. Circulation. Philadelphia: Lippincott Williams Wilkins, 2021, vol. 144, No 18, p. 1476-1484. ISSN 0009-7322. Available from: https://dx.doi.org/10.1161/CIRCULATIONAHA.121.057042.

@article{1834239,
   author = {Frobert, O. and Gotberg, M. and Erlinge, D. and Akhtar, Z. and Christiansen, E. H. and MacIntyre, C. R. and Oldroyd, K. G. and Motovska, Z. and Erglis, A. and Moer, R. and Hlinomaz, Ota and Jakobsen, L. and Engstrom, T. and Jensen, L. O. and Fallesen, C. O. and Jensen, S. E. and Angeras, O. and Calais, F. and Karegren, A. and Lauermann, J. and Mokhtari, A. and Nilsson, J. and Persson, J. and Stalby, P. and Islam, A. K. M. M. and Rahman, A. and Malik, F. and Choudhury, S. and Collier, T. and Pocock, S. J. and Pernow, J.},
   article_location = {Philadelphia},
   article_number = {18},
   doi = {http://dx.doi.org/10.1161/CIRCULATIONAHA.121.057042},
   keywords = {influenza vaccines; myocardial infarction; randomized controlled trial},
   language = {eng},
   issn = {0009-7322},
   journal = {Circulation},
   title = {Influenza Vaccination After Myocardial Infarction: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial},
   url = {https://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.121.057042},
   volume = {144},
   year = {2021}
}

TY  - JOUR
ID  - 1834239
AU  - Frobert, O. - Gotberg, M. - Erlinge, D. - Akhtar, Z. - Christiansen, E. H. - MacIntyre, C. R. - Oldroyd, K. G. - Motovska, Z. - Erglis, A. - Moer, R. - Hlinomaz, Ota - Jakobsen, L. - Engstrom, T. - Jensen, L. O. - Fallesen, C. O. - Jensen, S. E. - Angeras, O. - Calais, F. - Karegren, A. - Lauermann, J. - Mokhtari, A. - Nilsson, J. - Persson, J. - Stalby, P. - Islam, A. K. M. M. - Rahman, A. - Malik, F. - Choudhury, S. - Collier, T. - Pocock, S. J. - Pernow, J.
PY  - 2021
TI  - Influenza Vaccination After Myocardial Infarction: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial
JF  - Circulation
VL  - 144
IS  - 18
SP  - 1476-1484
EP  - 1476-1484
PB  - Lippincott Williams Wilkins
SN  - 00097322
KW  - influenza vaccines
KW  - myocardial infarction
KW  - randomized controlled trial
UR  - https://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.121.057042
N2  - 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.
ER  -

FROBERT, O., M. GOTBERG, D. ERLINGE, Z. AKHTAR, E. H. CHRISTIANSEN, C. R. MACINTYRE, K. G. OLDROYD, Z. MOTOVSKA, A. ERGLIS, R. MOER, Ota HLINOMAZ, L. JAKOBSEN, T. ENGSTROM, L. O. JENSEN, C. O. FALLESEN, S. E. JENSEN, O. ANGERAS, F. CALAIS, A. KAREGREN, J. LAUERMANN, A. MOKHTARI, J. NILSSON, J. PERSSON, P. STALBY, A. K. M. M. ISLAM, A. RAHMAN, F. MALIK, S. CHOUDHURY, T. COLLIER, S. J. POCOCK and J. PERNOW. Influenza Vaccination After Myocardial Infarction: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial. \textit{Circulation}. Philadelphia: Lippincott Williams Wilkins, 2021, vol.~144, No~18, p.~1476-1484. ISSN~0009-7322. Available from: https://dx.doi.org/10.1161/CIRCULATIONAHA.121.057042.

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