High Dose Versus Standard Dose Influenza Vaccine in Patients With High-Risk Cardiovascular Disease - INVESTED

Contribution To Literature:

The INVESTED trial showed that high dose influenza vaccine was not superior to standard dose in reducing death or cardiopulmonary hospitalizations among patients with high CV risk.

Description:

The goal of the trial was to assess the safety and efficacy of high dose vs. standard dose influenza vaccine in reducing cardiovascular (CV) events among patients with high CV risk.

Study Design

Patients were randomized in a 1:1 fashion to either high dose trivalent inactivated influenza vaccine (n = 2,630) or standard dose quadrivalent inactivated influenza vaccine (n = 2,630).

  • Total number of enrollees: 5,260
  • Duration of follow-up: 10 months
  • Mean patient age: 65 years
  • Percentage female: 28%

Inclusion criteria:

  • Post–myocardial infarction (MI) (12 months) or post–heart failure (HF) hospitalization (24 months)
  • One additional risk factor: age ≥65 years, left ventricular ejection fraction <40%, diabetes mellitus, body mass index >30, estimated glomerular filtration rate (eGFR) <60, history of ischemic stroke, history of peripheral artery disease, smoking, previous MI, previous HF hospitalization

Exclusion criteria:

  • Allergy to influenza vaccine or egg
  • History of Guillain–Barré syndrome
  • Reduced life expectancy <9 months
  • Acute infection or fever

Other salient features/characteristics:

  • MI: 37%
  • Chronic obstructive pulmonary disease: 20%

Principal Findings:

Mean time to primary outcome, mortality or hospitalizations for cardiac or pulmonary causes between high and standard dose vaccine formulations, was 44.5 per 100 patient-years vs. 41.9 per 100 patient-years (p > 0.05)

Secondary outcomes for high vs. standard dose:

  • Pain: 26.1% vs. 19.1% (p < 0.001)
  • Myalgias: 14% vs. 11.8% (p = 0.007)

Interpretation:

The results of this trial indicate that high dose influenza vaccine was not superior to standard dose in reducing death or cardiopulmonary hospitalizations among patients with high CV risk. Vaccination-related adverse events were higher with the higher dose.

References:

Presented by Dr. Orly Vardeny at the American Heart Association Virtual Scientific Sessions, November 17, 2020.

Clinical Topics: Heart Failure and Cardiomyopathies, Prevention, Acute Heart Failure, Diabetes and Cardiometabolic Disease

Keywords: AHA20, AHA Annual Scientific Sessions, Heart Failure, Influenza Vaccines, Influenza, Human, Myocardial Infarction, Myalgia, Primary Prevention, Risk Factors, Vaccination


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