Feasibility and Findings of Including Self-Identified Adult Congenital Heart Disease Patients in the INVESTED Trial
Primary resultResult — go to the resultAdjusted hazard ratio 1.17 95% CI 0.95–1.45Authors' 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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