Design and rationale for the I nfluenza vaccination A fter M yocardial I nfarction (IAMI) trial. A registry-based randomized clinical trial

Fröbert, Ole; Götberg, Matthias; Angerås, Oskar; Jonasson, Lena; Erlinge, David; Engstrøm, Thomas; Persson, Jonas; Jensen, Svend Eggert; Ömerovic, Elmir; James, Stefan; Lagerqvist, Bo; Nilsson, Johan; Kåregren, Amra; Moer, Rasmus; Cao, Yang; Agus, David B.; Ērglis, Andrejs; Jensen, Lisette Okkels; Jakobsen, Lars; Christiansen, Evald Høj; Pernow, John

doi:10.1016/j.ahj.2017.04.003

Cited by 43 publications

(37 citation statements)

References 47 publications

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“… 45. , 46. The INVESTED trial is comparing the effect of a high dose vaccine to a standard vaccine while the IAMI trial is randomizing patients with STEMI or non-STEMI undergoing coronary angiography to influenza vaccine or placebo.…”

Section: Discussionmentioning

confidence: 99%

Randomized controlled trial of influenza vaccine in patients with heart failure to reduce adverse vascular events (IVVE): Rationale and design

Loeb

Dokainish

Dans

et al. 2019

American Heart Journal

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Background Influenza is associated with an increase in the risk of cardiac and other vascular events. Observational data and small randomized trials suggest that influenza vaccination may reduce such adverse vascular events. Research Design and Methods In a randomized controlled trial patients with heart failure are randomized to receive either inactivated influenza vaccine or placebo annually for 3 years. Patients aged ≥18 years with a clinical diagnosis of heart failure and NYHA functional class II, III and IV are eligible. Five thousand patients from 10 countries where influenza vaccination is not common (Asia, the Middle East, and Africa) have been enrolled. The primary outcome is a composite of the following: cardiovascular death, non-fatal myocardial infarction, non-fatal stroke and hospitalizations for heart failure using standardized criteria. Analyses will be based on comparing event rates between influenza vaccine and control groups and will include time to event, rate comparisons using Poisson methods, and logistic regression. The analysis will be conducted by intention to treat i.e. patients will be analyzed in the group in which they were assigned. Multivariable secondary analyses to assess whether variables such as age, sex, seasonality modify the benefits of vaccination are also planned for the primary outcome. Conclusion This is the largest randomized trial to test if influenza vaccine compared to control reduces adverse vascular events in high risk individuals. Trial registration number Clinicaltrials.gov NCT02762851

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Section: Discussionmentioning

confidence: 99%

Randomized controlled trial of influenza vaccine in patients with heart failure to reduce adverse vascular events (IVVE): Rationale and design

Loeb

Dokainish

Dans

et al. 2019

American Heart Journal

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show abstract

“…The annual immunization is usually delivered in primary care setting and only occasionally patients are recruited in hospital after an acute event, adversely affecting the compliance. The IAMI study (Influenza vaccination After Myocardial Infarction), a large randomized multicentre prospective placebo-controlled trial enrolling patients with ST-segment elevation myocardial infarction (STEMI) or non-STEMI (NSTEMI) undergoing coronary angiography that received influenza vaccine in hospital in order to evaluate death and cardiovascular outcomes at 1 year, is currently ongoing [44]. First results are expected in late 2020 and will add high-quality evidence to guidelines recommending influenza vaccination for secondary prevention of cardiovascular disease.…”

Section: Discussionmentioning

confidence: 99%

Influenza coverage rates in subjects with chronic heart diseases: results obtained in four consecutive immunisation seasons in the Local Health Unit of Ferrara (North Italy)”

et al. 2020

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Background Seasonal influenza epidemics yearly affects 5–15% of the world’s population, resulting in 3–5 million serious cases and up to 650,000 deaths. According to the 2017–2019 Italian National Immunisation Plan, free immunisation is offered to the categories at increased risk of experience the complications of the infection (over 65 years old subjects, pregnant women and individuals with underlying conditions, including chronic heart diseases). Rising evidence suggests that influenza can trigger adverse cardiovascular events therefore the vaccination is recommended for secondary prevention of cardiovascular diseases. Despite this, the influenza coverage rate in subjects with chronic heart disease is underestimated. Methods The study investigated the coverage rate in four consecutive influenza seasons (from 2011/2012 to 2014/2015) in subjects that benefit from exemption from paying healthcare costs for chronic heart disease living in Local Health Unit (LHU) of Ferrara (Italy), comparing the databases of exemptions and immunisations. Results The levels of influenza vaccine uptake were unstable, reaching the 50.3% in 2011/2012 immunisation season and falling to 42.2% in the following year. Coverage rates increased with increasing age, without achieving the 75% target, neither in over 65 years old subjects. The logistic regression analysis showed that influenza coverage rates were statistically significant different (p < 0.0001, 0.003 only for category of disease in 2011/2012 immunisation season) according to age, district of residence, category of chronic heart disease and length of exemption, but not influenced by gender. Conclusions The recommendation of influenza immunisation was weakly followed in individuals with chronic heart diseases. A collaboration between cardiologists, GPs, scientific societies and patient associations could successfully support influenza vaccine uptake.

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“…In the USA, this indicator was very high and estimated to be about 67% in the group of vaccinated patients, compared to control samples. Furthermore, analyses of the influence of influenza vaccination on cardiovascular diseases [18,19] and other accompanying diseases, such as stroke, are constantly being carried out. All such research, often performed on big samples of respondents under longterm observation, undoubtedly confirms the effectiveness of vaccination in the fight against diseases, and the reduction of sudden morbidity cases, for example, myocardial infarction [16].…”

Section: Discussionmentioning

confidence: 99%

Factors affecting influenza vaccination decisions in patients with cardiovascular diseases – selected aspects of research

Choińska¹,

Poltz-Dacewicz²

2019

J Pre Clin Clin Res.

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Design and rationale for the I nfluenza vaccination A fter M yocardial I nfarction (IAMI) trial. A registry-based randomized clinical trial

Cited by 43 publications

References 47 publications

Randomized controlled trial of influenza vaccine in patients with heart failure to reduce adverse vascular events (IVVE): Rationale and design

Randomized controlled trial of influenza vaccine in patients with heart failure to reduce adverse vascular events (IVVE): Rationale and design

Influenza coverage rates in subjects with chronic heart diseases: results obtained in four consecutive immunisation seasons in the Local Health Unit of Ferrara (North Italy)”

Factors affecting influenza vaccination decisions in patients with cardiovascular diseases – selected aspects of research

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