Table 3.

Considerations for Patient Goals and Preferences for Medical Therapy Trials in AS

Patient population

• Age • Comorbidities • Historically underrepresented patients receiving therapy or participating in trials (e.g. women, minorities, rural patients) • Type of valve disease (bicuspid vs. trileaflet aortic valve) • Stage of disease (sclerosis vs. mild vs. moderate AS) • Native valve disease only vs. post-AVR

Trade-offs

• Medication for an asymptomatic condition versus avoiding or delaying AVR • Varying types of side effects of medication: physical symptoms, inconvenience, economic • Uncertainty regarding whether AVR will eventually be indicated during remaining life years

Implementation barriers to trial enrollment and strategies to address

• Patient perception of randomization vs. observational study design • Reaching underserved populations • Trust in medical system • Education on disease process • Consistent methodology for measuring and incorporating patient preferences • Drug delivery (daily vs. multiple doses, oral vs. subcutaneous vs. intravenous)

Abbreviations: AS, aortic stenosis; AVR, aortic valve replacement