Influenza Vaccination After Myocardial Infarction: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial
Jazyk angličtina Země Spojené státy americké Médium print-electronic
Typ dokumentu časopisecké články, multicentrická studie, randomizované kontrolované studie
- Klíčová slova
- influenza vaccines, myocardial infarction, randomized controlled trial,
- MeSH
- dvojitá slepá metoda MeSH
- infarkt myokardu imunologie MeSH
- lidé středního věku MeSH
- lidé MeSH
- vakcíny proti chřipce aplikace a dávkování imunologie MeSH
- výsledek terapie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- randomizované kontrolované studie MeSH
- Názvy látek
- vakcíny proti chřipce MeSH
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.
Cardiology Heart Centre Department of Public Health and Clinical Medicine Umeå University Sweden
Department of Cardiology Aarhus University Hospital Denmark
Department of Cardiology Karlstad Central Hospital Sweden
Department of Cardiology Odense University Hospital Denmark
Department of Cardiology Skane University Hospital Clinical Sciences Lund University Sweden
Department of Medical Statistics London School of Hygiene and Tropical Medicine United Kingdom
International Centre for Diarrhoeal Disease Research Bangladesh Dhaka
LHL sykehuset Gardermoen Oslo Norway
National Heart Foundation Hospital and Research Institute Dhaka Bangladesh
National Institute of Cardiovascular Diseases Sher e Bangla Nagar Dhaka Bangladesh
Örebro University Faculty of Health Department of Cardiology Sweden
Pauls Stradins Clinical University Hospital University of Latvia Riga
Rigshospitalet University of Copenhagen Denmark
The Kirby Institute UNSW Medicine University of New South Wales Sydney Australia
Citace poskytuje Crossref.org
Secondary Prevention after Myocardial Infarction: What to Do and Where to Do It
ClinicalTrials.gov
NCT02831608
