Sex-Specific Outcomes in Cardiovascular Device Evaluations

Area of Science:

• Cardiovascular Medicine
• Clinical Trials
• Medical Devices

Background:

• Historically, females are underrepresented in cardiovascular device trials.
• This disparity hinders the determination of sex-specific outcomes and treatment efficacy.
• Troubling trends in cardiovascular outcomes for females necessitate a review of device trial participation.

Purpose of the Study:

• To review sex-based outcome differences in cardiovascular device evaluations.
• To examine female representation in trials for coronary revascularization, structural heart disease, and heart failure.
• To identify predictors of female nonparticipation to improve trial enrollment.

Main Methods:

• Narrative review of existing literature on cardiovascular device trials.
• Analysis of female representation across different cardiovascular device indications.
• Review of factors influencing female participation in clinical trials.

Main Results:

• Female representation in transcatheter aortic valve replacement studies approached 50%.
• Average female enrollment was 25% in trials for drug-eluting stents, ICDs, CRT-Ds, and VADs.
• Significant disparities in female recruitment were observed in coronary revascularization and heart failure trials.

Conclusions:

• Underrepresentation of females in device trials leads to uncertainty in benefit/risk assessments for these populations.
• Treatment recommendations for females are often based on male-dominated study outcomes.
• Strategies to enhance female enrollment are crucial for addressing sex differences and optimizing cardiovascular care.