Academic Research Organization, Hospital Israelita Albert Einstein, Rua Comendador Elias Jafet, 755, 4° andar, São Paulo 05652-900, Brazil.
Cardiology Division, Hospital Israelita Albert Einstein, Av. Albert Einstein, 627/701, São Paulo, Brazil.
Eur Heart J. 2022 Nov 1;43(41):4378-4388. doi: 10.1093/eurheartj/ehac472.
To evaluate whether a strategy of double-dose influenza vaccination during hospitalization for an acute coronary syndrome (ACS) compared with standard-dose outpatient vaccination (as recommended by current guidelines) would further reduce the risk of major cardiopulmonary events.
Vaccination against Influenza to Prevent cardiovascular events after Acute Coronary Syndromes (VIP-ACS) was a pragmatic, randomized, multicentre, active-comparator, open-label trial with blinded outcome adjudication comparing two strategies of influenza vaccination following an ACS: double-dose quadrivalent inactivated vaccine before hospital discharge vs. standard-dose quadrivalent inactivated vaccine administered in the outpatient setting 30 days after randomization. The primary outcome was a hierarchical composite of all-cause death, myocardial infarction, stroke, unstable angina, hospitalization for heart failure, urgent coronary revascularization, and hospitalization for respiratory causes, analysed by the win ratio method. Patients were followed for 12 months. During two influenza seasons, 1801 participants were included at 25 centres in Brazil. The primary outcome was not different between groups, with 12.7% wins in-hospital double-dose vaccine group and 12.3% wins in the standard-dose vaccine group {win ratio: 1.02 [95% confidence interval (CI): 0.79-1.32], P = 0.84}. Results were consistent for the key secondary outcome, a hierarchical composite of cardiovascular death, myocardial infarction and stroke [win ratio: 0.94 (95% CI: 0.66-1.33), P = 0.72]. Time-to-first event analysis for the primary outcome showed results similar to those of the main analysis [hazard ratio 0.97 (95% CI: 0.75-1.24), P = 0.79]. Adverse events were infrequent and did not differ between groups.
Among patients hospitalized with an ACS, double-dose influenza vaccination before discharge did not reduce cardiopulmonary outcomes compared with standard-dose vaccination in the outpatient setting.
ClinicalTrials.gov number: NCT04001504.
评估与标准剂量门诊疫苗接种（如现行指南建议）相比，在因急性冠状动脉综合征（ACS）住院期间进行双倍剂量流感疫苗接种的策略是否会进一步降低主要心肺事件的风险。
预防急性冠状动脉综合征后心血管事件的流感疫苗接种（VIP-ACS）是一项实用的、随机的、多中心、活性对照、开放标签试验，采用盲法结果判断，比较了 ACS 后两种流感疫苗接种策略：出院前给予四价灭活双倍剂量疫苗与随机分组后 30 天在门诊给予四价灭活标准剂量疫苗。主要终点为全因死亡、心肌梗死、卒、不稳定型心绞痛、心力衰竭住院、紧急冠状动脉血运重建和因呼吸系统原因住院的复合终点，采用优势比法进行分析。患者随访 12 个月。在两个流感季节，共有 1801 名患者在巴西的 25 个中心入组。两组之间主要终点无差异，住院期间双倍剂量疫苗组有 12.7%的优势，标准剂量疫苗组有 12.3%的优势（优势比：1.02[95%置信区间（CI）：0.79-1.32]，P=0.84）。主要次要终点，即心血管死亡、心肌梗死和卒的复合终点也有一致的结果（优势比：0.94[95%CI：0.66-1.33]，P=0.72）。主要终点的首次事件时间分析结果与主要分析结果相似（风险比 0.97[95%CI：0.75-1.24]，P=0.79）。不良事件罕见，且两组间无差异。
在因 ACS 住院的患者中，与在门诊给予标准剂量疫苗相比，出院前给予双倍剂量流感疫苗接种并未降低心肺结局。
ClinicalTrials.gov 编号：NCT04001504。
