Congenital heart disease

Feasibility and Findings of Including Self-Identified Adult Congenital Heart Disease Patients in the INVESTED Trial

JACC AdvPublished Secondary analysis of the INVESTED randomised trial

Primary resultResult — go to the resultAdjusted hazard ratio 1.17 95% CI 0.95–1.45

Authors' conclusion

Patients who self-identify as being ACHD had similar primary outcome of all-cause death or hospitalization for cardiovascular or pulmonary causes compared to non-ACHD cohort. High-dose influenza vaccination was similar to standard-dose influenza vaccination on the primary outcome in patients who self-identify as ACHD.

Study context

Population
Patients in the INVESTED influenza vaccine trial, self-identified adult congenital heart disease (ACHD) vs non-ACHDACHD: 132 high-dose, 140 standard-dose
Participants
272 vs 4,988
Comparison
Self-identified ACHD vs non-ACHD patients receiving high- or standard-dose influenza vaccine
  • ACHDn = 272
  • non-ACHDn = 4,988reference
Primary endpoint
All-cause death or hospitalisation for CV or pulmonary causes
Methodological detailsprospectively included subgroup
  • Prospectively included subgroup

Primary result

As reported in the abstract

Adjusted hazard ratio

1.17

95% CI 0.95–1.45

P = 0.144

By group

ACHD

49.8 events per 100 person-years

non-ACHD

42.8 events per 100 person-years

ACHDvs non-ACHD
adjusted HR 1.17 (95% CI 0.95–1.45); P = 0.144

Further findings

High-dose vs standard-dose vaccine effect on primary outcome by ACHD status

Interaction between ACHD status and randomised treatment effect not significant
P = 0.858

Safety

Vaccine-related adverse events

Similar in both groups

Original publication

Feasibility and Findings of Including Self-Identified Adult Congenital Heart Disease Patients in the INVESTED Trial. JACC Adv. Published 14 March 2024. doi:10.1016/j.jacadv.2024.100897

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