Influenza vaccine to reduce adverse vascular events in patients with heart failure: a multinational randomised, double-blind, placebo-controlled trial

作者：Mark Loeb, Ambuj Roy, Hisham Dokainish, Antonio Dans, Lia M. Palileo‐Villanueva, Kamilu M. Karaye, Jun Zhu, Yan Liang, Fastone Goma, Albertino Damasceno, Khalid F. AlHabib, Gerald Yonga, Charles Mondo, Wael Almahmeed, Arif Al Mulla, Vitheya Thanabalan, Rao Ps, Alex Grinvalds, Tara McCready, Shrikant I. Bangdiwala, Salim Yusuf · 发表于：The Lancet Global Health · 年份：2022 · DOI：10.1016/s2214-109x(22)00432-6 · 被引用次数：82 · 研究领域：Influenza Virus Research Studies、Renin-Angiotensin System Studies、Respiratory viral infections research

BACKGROUND: Influenza increases the risk of cardiovascular events and deaths. We aimed to see whether influenza vaccination reduces death and vascular events in patients with heart failure. METHODS: We did a pragmatic, randomised, double-blind, placebo-controlled trial in 30 centres (mostly hospitals affliated with universities or a research institute) in ten countries in Asia, the Middle East, and Africa (7 in India, 4 in Philippines, 4 in Nigeria, 6 in China, 1 in Zambia, 2 in Mozambique, 3 in Saudi Arabia, 1 in Kenya, 1 in Uganda, and 1 in Zambia). Participants (aged ≥18 years; 52·1% female; not disaggregated by race or ethnicity) with heart failure (New York Heart Association class II, III, or IV) were randomly assigned (1:1) by a centralised web-based system with block randomisation stratified by site, to receive 0·5 ml intramuscularly once a year for up to 3 years of either inactivated standard dose influenza vaccine or placebo (saline). We excluded people who had received influenza vaccine in 2 of the previous 3 years, and those likely to require valve repair or replacement. Those who administered assigned treatments were not masked and had no further role in the study. Investigators, study coordinators, outcome adjudicators, and participants were masked to group assignment. The first of two co-primary outcomes was a first-event composite for cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke, and the second was a recurrent-events composite for...