Valvular Heart Disease Interventional Trials From 2000 to 2024: A Systematic Review

Area of Science:

• Cardiovascular Medicine
• Clinical Trials
• Medical Interventions

Background:

• Valvular heart disease (VHD) is a significant and growing cause of cardiovascular morbidity, particularly affecting aging populations.
• The expansion of transcatheter therapies necessitates an evaluation of clinical trial enrollment trends and demographic representation to ensure evidence generalizability and equity.

Purpose of the Study:

• To analyze temporal trends in the characteristics and demographic representation, specifically age and sex, of participants in interventional trials for valvular heart disease.
• To assess changes in trial scope, intervention types, and participant demographics in VHD trials from 2000 to 2024.

Main Methods:

• A systematic review of interventional VHD trials indexed in PubMed from 2000 to 2024 was performed.
• Included trials focused on percutaneous or surgical interventions for aortic, mitral, tricuspid, and pulmonic valve diseases.
• Descriptive and nonparametric statistics were employed to evaluate trends in enrollment, participant demographics, valve type, intervention modality, and trial scope.

Main Results:

• The study included 487 trials with 87,412 participants; 44.9% were women.
• Median trial size and participant age significantly increased over time (P < 0.01).
• There was a notable rise in percutaneous interventions, bioprosthetic valves, aortic valve trials, and multinational studies. Female enrollment did not significantly improve (P = 0.63) but was higher in mitral and tricuspid valve trials, and in percutaneous versus surgical studies. A positive correlation was found between participant age and female representation (P < 0.01).

Conclusions:

• VHD trials have grown in scale and scope, with a trend toward older participants.
• Despite increased trial size and age, persistent sex disparities in enrollment highlight the need for more inclusive trial designs.
• Equitable representation in VHD clinical trials is crucial for developing therapies that benefit all patient populations.