Risk of Worsening Heart Failure and All-Cause Mortality Following COVID-19 Vaccination in Patients With Heart Failure: A Nationwide Real-World Safety Study

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningfagfællebedømt

Patients with heart failure are vulnerable to the SARS-CoV-2 infection. However, limited evidence exists on the safety of the SARS-CoV-2 mRNA vaccines in this patient population. The objective of this study was to investigate the risk of all-cause mortality, worsening heart failure, venous thromboembolism, and myocarditis associated with the mRNA vaccines in patients with heart failure.

Using Danish nationwide registries, 2 cohorts were constructed: (1) all prevalent heart failure patients in 2019 aged 40 to 95 years and (2) all prevalent heart failure patients in 2021 aged 40 to 95 years, who were vaccinated with either of the 2 mRNA vaccines (BNT162B2 or mRNA-1273). The patients in the 2 cohorts were matched 1:1 using exact exposure matching on age, sex, and duration of heart failure. To estimate standardized absolute risks, outcome-specific Cox regression analyses were performed.

The total study population comprised 101 786 patients. The median age of the study population was 74 years (interquartile range, 66–81). The standardized risk of all-cause mortality within 90 days was 2.23% (95% CI, 2.10%–2.36%) in the vaccinated cohort and 2.56% (95% CI, 2.43%–2.70%) in the unvaccinated cohort (90-day risk difference, −0.33% [95% CI, −0.52% to −0.15%]). The standardized risk of worsening heart failure within 90 days was 1.10% (95% CI, −1.01% to 1.19%) in the 2021 (vaccinated) cohort and 1.08% (95% CI, 0.99%–1.17%) in the 2019 (unvaccinated) cohort (risk difference, 0.02% [95% CI, −0.11% to 0.15%]). No significant differences were found regarding venous thromboembolism or myocarditis.

Receiving an mRNA vaccine was not associated with an increased risk of worsening heart failure, myocarditis, venous thromboembolism, or all-cause mortality.
TidsskriftCirculation: Heart Failure
Udgave nummer10
Sider (fra-til)859-869
Antal sider11
StatusUdgivet - 2023

Bibliografisk note

Funding Information:
Dr Biering-Sørensen is a Steering Committee member of the Amgen-financed GALACTIC-HF trial; Chief Investigator and Steering Committee Chair of the Sanofi Pasteur–financed NUDGE-FLU trial; Chief Investigator and Steering Committee Chair of the Sanofi Pasteur–financed DANFLU-1 trial; Chief Investigator and Steering Committee Chair of the Sanofi Pasteur–financed DANFLU-2 trial; Steering Committee member of the LUX-Dx TRENDS Evaluates Diagnostics Sensors in Heart Failure Patients Receiving Boston Scientific Investigational ICM System trial; advisory board member of Sanofi Pasteur, Amgen, and GSK; receives speaker honorarium from Novartis, Sanofi Pasteur, and GSK; and receives research grants from GE Healthcare and Sanofi Pasteur. Dr Torp-Pedersen reports grants from Bayer and Novo Nordisk, outside the submitted work. The other authors report no conflicts.

Funding Information:
This study was supported by an unrestricted grant from Læge Sofus Carl Emil Friis og Hustru Olga Doris Friis’ Legat. The sponsor had no influence on the study design, interpretation of results, or the decision to submit the manuscript for publication.

Publisher Copyright:
© 2023 The Authors. Circulation: Cardiovascular Interventions is published on behalf of the American Heart Association, Inc., by Wolters Kluwer Health, Inc.

ID: 372204476