Lower response to preventive cardiovascular interventions in adolescent and young adult female CHD patients

Abstract

Introduction

Results from three randomized clinical trials (QUALIREHAB, TRANSITION, and SOPRHOCARE) carried out by our group were recently reported on the efficacy of a regimented preventive program on exercise capacity and quality of life (QOL) outcomes in adolescents and young adults with congenital heart disease (CHD). Leveraging this data, we aimed to investigate gender differences in outcomes of these three patient populations.

Method

A post-hoc analysis from 13-to-25 year-old CHD patients, enrolled in the intervention group of one of the 3 clinical trials was conducted. The QUALREHAB trial consisted of 70 randomized patients (54% females, mean age 17.1 ± 3.5 years), the SOPHROCARE trial consisted of 99 randomized patients (58% females, mean age of 16.9 ± 3.5 years), and the TRANSITION trial consisted of 94 randomized patients (44% females, mean age of 18.9 ± 3.7 years). Gender differences were assessed across exercise capacity outcomes and QOL measures using intention-to-treat (ITT) analysis and the per-protocol analysis within each randomized clinical trial. Differences were also assessed within gender in the randomized and controlled groups. Absolute differences (AD) between groups were reported. All comparisons were adjusted for age and baseline values.

Results

Gender differences were identified in the ITT analysis for QUALIREHAB in physical and emotional QOL domains (AD = − 9.68, p = 0.0.3 and −9.95, p = 0.01, respectively) and in the per-protocol analysis for QUALIREHAB in theoretical VO2max (AD = − 8.49, p = 0.05). Smaller gender differences were observed in the ITT analysis for the SOPHROCARE trial in VAT and VO2max domains (AD = − 2.19, p = 0.03 and −2.78, p = 0.048, respectively) and in the per-protocol analysis for SOPHROCARE in VAT (AD = − 3.29, p = 0.0024). There were no gender differences observed in the ITT or per-protocol analyses for the TRANSITION trial, however differences existed between the females in randomized and controlled cohorts in both ITT and per-protocol analyses.

Conclusion

Female patients with CHD may have lower exercise capacity and lower QOL scores following certain preventive interventions designed to improve these outcomes. While the TRANSITION trial did not show differences between genders, there was a difference between randomized and controlled females, indicating that the patient education component in this trial may play an important role in facilitating outcomes and should be further explored.