Aortic Valve Stenosis and Insufficiency, Coronary Artery Disease(CAD), Transcatheter Aortic Valve Replacement (TAVR)
Conditions
Keywords
TAVR-CT, PCD-CT, Severe Aortic Stenosis, Transcatheter Aortic Valve Replacement, TAVR, Photon-Counting Detector CT, Randomized Controlled Trial
Brief summary
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.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTStandard Invasive Coronary Angiography
Standard invasive coronary angiography performed routinely for all participants in this arm to assess coronary artery disease before TAVR.
DIAGNOSTIC_TESTPCD-CT-Guided Diagnostic Strategy
Participants 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.
Sponsors
Medical University Innsbruck
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Masking description
An independent, blinded Clinical Events Committee will adjudicate all primary and key secondary endpoints based on medical records. The committee members will not be informed of the participants' group allocation (PCD-CT vs. ICA). The statistical analysis will also be conducted by an independent statistician blinded to treatment assignment.
Intervention model description
Randomized, controlled, multicenter, open-label, parallel-group, two-arm non-inferiority trial. Participants are assigned in a 1:1 ratio to either a PCD-CT-guided diagnostic strategy or standard invasive coronary angiography prior to TAVR evaluation.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major adverse cardiovascular events (MACE) at 12 months | 12 months after randomization | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cardiovascular mortality at 12 months | 12 months after randomization | 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 | 12 months after randomization | Nonfatal myocardial infarction will be defined according to the Fourth Universal Definition and the VARC-3 criteria, including periprocedural and spontaneous events. |
| All-cause mortality at 12 months | 12 months after randomization | All-cause mortality is defined as death from any cause. |
| Urgent revascularization at 12 months | 12 months after randomization | Defined as unplanned hospital admission or in-hospital acute coronary syndrome requiring revascularization during the same hospitalization. |
| Bleeding events at 12 months | 12 months after randomization | Bleeding events will be classified according to VARC-3 bleeding definitions, types 2 to 4. |
| Nonfatal stroke at 12 months | 12 months after randomization | Nonfatal stroke is defined as a neurological deficit ≥24 hours caused by ischemia or intracranial bleeding, classified per VARC-3. |
Countries
Austria
Contacts
Primary ContactSebastian J Reinstadler, MD, PhD
Backup ContactIvan Lechner, MD, PhD
Outcome results
None listed