Assessment of Coronary Artery Disease Before Transcatheter Aortic Valve Replacement: A Randomized, Multicenter, Non-Inferiority Trial

Assessment of Coronary Artery Disease Before Transcatheter Aortic Valve Replacement: A Randomized, Multicenter, Non-Inferiority Trial

The goal of this clinical trial is to determine whether a non-invasive coronary assessment strategy using photon-counting detector computed tomography (PCD-CT) is non-inferior to invasive coronary angiography (ICA) for evaluating coronary artery disease (CAD) prior to transcatheter aortic valve replacement (TAVR) in patients with severe aortic stenosis.

The goal of this randomized, multicenter trial is to assess the safety and efficacy of a non-invasive diagnostic strategy using photon-counting detector computed tomography (PCD-CT) for the assessment of coronary artery disease (CAD) prior to transcatheter aortic valve replacement (TAVR), compared to the current standard of care using invasive coronary angiography (ICA).

The trial evaluates the hypothesis that a PCD-CT-guided strategy is non-inferior to routine ICA with respect to the risk of major adverse cardiovascular events (MACE) at 12 months. MACE is defined as a composite of all-cause mortality, nonfatal myocardial infarction, nonfatal stroke, urgent revascularization, or bleeding.

Inclusion Criteria:

• Age ≥ 18 years
• Severe aortic valve stenosis and indication for intervention according to current European Society of Cardiology (ESC) guidelines
• TAVR candidate
• Written informed consent

Exclusion Criteria:

• Cardiogenic shock at presentation (e.g., emergency indication for TAVR)
• Severe renal impairment with an estimated glomerular filtration rate of <30 mL/min/1.73 m²
• Life expectancy <1 year due to other severe non-cardiac disease (e.g., malignancy)
• Pregnancy