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.

Základní údaje

Originální název

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

Autoři

FROBERT, O. (garant), M. GOTBERG, D. ERLINGE, Z. AKHTAR, E. H. CHRISTIANSEN, C. R. MACINTYRE, K. G. OLDROYD, Z. MOTOVSKA, A. ERGLIS, R. MOER, Ota HLINOMAZ (203 Česká republika, domácí), 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 a J. PERNOW

Vydání

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

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30201 Cardiac and Cardiovascular systems

Stát vydavatele

Spojené státy

Utajení

není předmětem státního či obchodního tajemství

Odkazy

URL

Impakt faktor

Impact factor: 39.918

Kód RIV

RIV/00216224:14110/21:00124147

Organizační jednotka

Lékařská fakulta

DOI

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

UT WoS

000747313100007

Klíčová slova anglicky

influenza vaccines; myocardial infarction; randomized controlled trial

Štítky

14110115, rivok

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 15. 2. 2022 07:51, Mgr. Tereza Miškechová

Anotace

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 a J. PERNOW. Influenza Vaccination After Myocardial Infarction: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial. Circulation. Philadelphia: Lippincott Williams Wilkins, 2021, roč. 144, č. 18, s. 1476-1484. ISSN 0009-7322. Dostupné z: 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 a J. PERNOW. Influenza Vaccination After Myocardial Infarction: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial. \textit{Circulation}. Philadelphia: Lippincott Williams Wilkins, 2021, roč.~144, č.~18, s.~1476-1484. ISSN~0009-7322. Dostupné z: https://dx.doi.org/10.1161/CIRCULATIONAHA.121.057042.

Podrobný výpis o publikaci