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.
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
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
Parallel
Standard Invasive Coronary Angiography
Diagnostic testStandard invasive coronary angiography performed routinely for all participants in this arm to assess coronary artery disease before TAVR.
PCD-CT-Guided Diagnostic Strategy
Diagnostic testParticipants randomized to this arm will undergo coronary artery disease (CAD) assessment using photon-counting detector computed tomography (PCD-CT). Invasive coronary angiography (ICA) will only be performed if PCD-CT shows significant CAD, defined as ≥70% diameter stenosis in vessels ≥2.5 mm or ≥50% in the left main artery.
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 events. All events will be adjudicated by an independent, blinded clinical events committee.
All-cause mortality at 12 months
All-cause mortality is defined as death from any cause.
Cardiovascular mortality at 12 months
Cardiovascular death is defined as any death due to proximate cardiac or vascular cause, including death during ICA, PCD-CT, or TAVR procedures.
Nonfatal myocardial infarction at 12 months
Nonfatal myocardial infarction will be defined according to the Fourth Universal Definition and the VARC-3 criteria, including periprocedural and spontaneous events.
Nonfatal stroke at 12 months
Nonfatal stroke is defined as a neurological deficit ≥24 hours caused by ischemia or intracranial bleeding, classified per VARC-3.
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