Influenza vaccination strategy in acute coronary syndromes: the VIP-ACS trial.

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.

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Déclaration de conflit d'intérêts

Conflict of interest: H.A.R.F. reports research grants from AstraZeneca and Brazilian Ministry of Health; R.H.M.F. reports research grants and personal fees from AstraZeneca, Bayer, Biomm and Servier; and research grants from Amgen, Pfizer, EMS, Aché, CytoDin, Brazilian Ministry of Health, University Health Network (received from his institution), and Lemann Foundation Research Fellowship. A.Z. reports research scholarships from the Brazilian National Council for Scientific and Technological Development (CNPq) and the Lemann Foundation Research Fellowship; M.F. reports research grants from Brazilian Ministry of Health; P.A.L., supported in part by a grant from The National Council for Scientific and Technological Development (CNPq)—Brazil (grant # 308733/2016-9); non-paid clinical advisor of Flouit, a scientific computing initiative; part of Argonauts, an innovation facilitator; B.R.N. is partially financed CNPq (Bolsa de produtividade em pesquisa, 312382/2019-7), by the Edwards Lifesciences Foundation (Improving the Prevention and Detection of Heart Valve Disease Across the Lifespan, 2021) and by FAPEMIG (grant APQ-000627-20); J.C.N. reports research grants from Amgen, Astrazeneca, Bayer, CSL Behring, Daiichi Sankyo, Dalcor, Esperion, Janssen, Novartis, NovoNordisk, Sanofi and Vifor, research support from the Brazilian Council for Scientific and Technological Development (CNPq); O.B. received research grants (paid to his institution) from AstraZeneca, Pfizer, Bayer, Amgen, Servier, BMS, and Novartis. The other authors declare no conflict of interest.