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

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

Maternal care practices among the ultra poor households in rural Bangladesh: a qualitative exploratory study

<p>Abstract</p> <p>Background</p> <p>Although many studies have been carried out to learn about maternal care practices in rural areas and urban-slums of Bangladesh, none have focused on ultra poor women. Understanding the context in which women would be willing to accept new practices is essential for developing realistic and relevant behaviour change messages. This study sought to fill in this knowledge gap by exploring maternal care practices among women who participated in a grant-based livelihood programme for the ultra poor. This is expected to assist the designing of the health education messages programme in an effort to improve maternal morbidity and survival towards achieving the UN millennium Development Goal 5.</p> <p>Methods</p> <p>Qualitative method was used to collect data on maternal care practices during pregnancy, delivery, and post-partum period from women in ultra poor households. The sample included both currently pregnant women who have had a previous childbirth, and lactating women, participating in a grant-based livelihood development programme. Rangpur and Kurigram districts in northern Bangladesh were selected for data collection.</p> <p>Results</p> <p>Women usually considered pregnancy as a normal event unless complications arose, and most of them refrained from seeking antenatal care (ANC) except for confirmation of pregnancy, and no prior preparation for childbirth was taken. Financial constraints, coupled with traditional beliefs and rituals, delayed care-seeking in cases where complications arose. Delivery usually took place on the floor in the squatting posture and the attendants did not always follow antiseptic measures such as washing hands before conducting delivery. Following the birth of the baby, attention was mainly focused on the expulsion of the placenta and various maneuvres were adapted to hasten the process, which were sometimes harmful. There were multiple food-related taboos and restrictions, which decreased the consumption of protein during pregnancy and post-partum period. Women usually failed to go to the healthcare providers for illnesses in the post-partum period.</p> <p>Conclusion</p> <p>This study shows that cultural beliefs and norms have a strong influence on maternal care practices among the ultra poor households, and override the beneficial economic effects from livelihood support intervention. Some of these practices, often compromised by various taboos and beliefs, may become harmful at times. Health behavior education in this livelihood support program can be carefully tailored to local cultural beliefs to achieve better maternal outcomes.</p

Clinical Impact of Influenza Vaccination after ST- and Non-ST-segment elevation Myocardial Infarction Insights from the IAMI trial.

BACKGROUND: Influenza vaccination early after myocardial infarction (MI) improves prognosis but vaccine effectiveness may differ dependent on type of MI. METHODS: A total of 2571 participants were prospectively enrolled in the IAMI trial and randomly assigned to receive in-hospital inactivated influenza vaccine or saline placebo. The trial was conducted at 30 centers in 8 countries from October 1, 2016 to March 1, 2020. Here we report vaccine effectiveness in the 2467 participants with ST-segment elevation MI (STEMI, n=1348) or non-ST-segment elevation MI (NSTEMI, n=1119). The primary endpoint was the composite of all-cause death, MI, or stent thrombosis at 12 months. Cumulative incidence of the primary and key secondary endpoints by randomized treatment and NSTEMI/STEMI was estimated using the Kaplan-Meier method. Treatment effects were evaluated with formal interaction testing to assess for effect modification. RESULTS: Baseline risk was higher in participants with NSTEMI. In the NSTEMI group the primary endpoint occurred in 6.5% of participants assigned to influenza vaccine and 10.5% assigned to placebo (hazard ratio [HR], 0.60; 95% CI, 0.39-0.91), compared to 4.1% assigned to influenza vaccine and 4.5% assigned to placebo in the STEMI group (HR, 0.90; 95% CI, 0.54-1.50, P=0.237 for interaction). Similar findings were seen for the key secondary endpoints of all-cause death and cardiovascular death. The Kaplan-Meier risk difference in all-cause death at 1 year was more pronounced in participants with NSTEMI (NSTEMI: HR, 0.47; 95% CI 0.28-0.80, STEMI: HR, 0.86; 95% CI, 0.43-1.70, interaction P=0.028). CONCLUSIONS: The beneficial effect of influenza vaccination on adverse cardiovascular events may be enhanced in patients with NSTEMI compared to those with STEMI