Comparing Non-Invasive and Invasive Coronary Artery Disease Assessment Before Transcatheter Aortic Valve Implantation in Older Adults with Severe Aortic Stenosis

What this Trial Is About

Researchers are investigating strategies to assess coronary artery disease CAD in patients with severe, symptomatic aortic stenosis who are selected to undergo transcatheter aortic valve implantation TAVI. The trial compares a non-invasive risk management approach with routine invasive coronary angiography to determine how these methods affect adverse clinical outcomes over three years and patient-reported health status. This study addresses uncertainties about the benefits and risks of invasive procedures before valve treatment, as treating aortic stenosis itself may reduce symptoms and ischemic burden. Patients are randomly assigned to one of two groups. One group will receive a risk-based strategy without routine invasive coronary angiography, with recommended statin treatment of at least moderate intensity. The other group will undergo routine invasive coronary angiography before TAVI, with percutaneous coronary intervention PCI advised for severe coronary artery narrowing 80% or more in arteries of sufficient size. The timing of PCI is flexible and decided by the treating physician. Participants will be followed for three years to monitor outcomes including death, heart attacks, strokes, and hospitalizations for heart failure. Patient-reported health status will also be collected at multiple time points up to five years. Monitoring includes assessment of cardiovascular events, bleeding, kidney injury, heart rhythm problems, and complications related to the valve and pacemaker implantation. This comprehensive follow-up aims to clarify the safety and impact of the two assessment strategies over time.

Coronary Artery Disease Assessment Strategies in TAVI Patients