A Randomised Controlled Trial of Early Valve Replacement in Severe Asymptomatic Aortic Stenosis

What this Trial Is About

Aortic stenosis AS affects many older adults, especially those over 65 years old, with increasing numbers due to an aging population. This condition often progresses silently until serious symptoms appear, requiring valve replacement surgery AVR or transcatheter aortic valve implantation TAVI. This research aims to compare early valve replacement to regular monitoring in patients with severe AS who have no symptoms, to understand which approach leads to better health outcomes and cost-effectiveness. The study is a large, open, randomized controlled trial conducted in multiple countries, including the UK, Australia, and New Zealand. Participants with severe asymptomatic AS will be randomly assigned to receive either early valve replacement surgery or ongoing regular monitoring without immediate surgery. Those in the surgery group will be placed on a waiting list aiming for surgery within three months and may undergo additional routine tests like coronary angiography. The monitoring group will continue with standard care and regular check-ups. Participants will be followed for at least three years to track outcomes such as cardiovascular death and hospitalizations for heart failure, along with quality of life and health economics measurements. The study includes regular assessments, questionnaires, and record linkages up to five years. Researchers will analyze outcomes based on the group participants were assigned to, regardless of actual treatment received, to provide clear information on the benefits and risks of early surgery versus expectant management.

The Early Valve Replacement in Severe ASYmptomatic Aortic Stenosis Study