Coronary Artery Disease Assessment Strategies in TAVI Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Risk-based CAD management, Invasive coronary angiography.
- Who it may be relevant to
- Registry conditions: Transcatheter Aortic Valve Replacement, Coronary Artery Disease, Heart Disease Risk Factors. Basic parameters: from 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Randomized Trial of Coronary Artery Disease Assessment Strategies in Patients With Severe Aortic Stenosis Undergoing Transcatheter Aortic Valve Implantation
Overview
Coronary artery disease (CAD) and aortic stenosis frequently coincide. Before valve intervention, invasive coronary angiography is routinely performed to assess coronary status. As the impact of percutaneous revascularization on clinical outcomes beyond symptom improvement is subject to debate and treatment of aortic stenosis itself reduces ischemic burden and symptoms, the benefit/risk balance of routine invasive coronary angiography prior to transcatheter aortic valve implantation (TAVI) is unclear. The CAT Trial aims to compare a non-invasive risk management strategy to routine invasive coronary angiography for the assessment of coronary artery disease in patients with severe, symptomatic aortic stenosis selected to undergo TAVI with respect to adverse clinical outcomes at 3 years (primary objective) and patient reported outcome measures (secondary objective).
Interventions
- Diagnostic test Risk-based CAD management
Patients will not undergo routine coronary angiography prior to TAVI. Statin treatment of at least moderate intensity is recommended. - Diagnostic test Invasive coronary angiography
Routine invasive coronary angiography prior to TAVI. PCI recommended for coronary diameter stenosis of ≥ 80% (visual angiographic assessment) in coronary segments with a reference vessel diameter of at least 2.5 mm. Timing of PCI at the operators' discretion.
Primary outcome measures
- Composite of all-cause death, myocardial infarction, any stroke, and heart failure hospitalization [Time frame: 3 years]
Secondary outcome measures (12)
- Patient reported health status [Time frame: 3 months, 1, 3 and 5 years]
- Patient reported health status [Time frame: 3 months, 1, 3 and 5 years]
- Patient reported health status [Time frame: 3 months, 1, 3 and 5 years]
- Rate of all cause death [Time frame: 3 months, 1, 3 and 5 years]
- Rate of cardiovascular death [Time frame: 3 months, 1, 3 and 5 years]
- Rate of disabling strokes [Time frame: 3 months, 1, 3 and 5 years]
- Rate of myocardial infarction [Time frame: 3 months, 1, 3 and 5 years]
- Rate of unplanned, urgent revascularization [Time frame: 3 months, 1, 3 and 5 years]
- Rate of elective revascularization [Time frame: 3 months, 1, 3 and 5 years]
- Rate of cardiovascular hospitalization [Time frame: 3 months, 1, 3 and 5 years]
- Rate of heart failure hospitalization [Time frame: 3 months, 1, 3 and 5 years]
- Rate of bleeding [Time frame: 3 months, 1, 3 and 5 years]
Eligibility criteria
Inclusion:
- Severe aortic stenosis defined by aortic valve area (AVA) ≤1cm2 AND mean gradient ≥40 mmHg or peak velocity ≥4.0 m/s
OR
if mean gradient <40 mmHg and peak velocity (Vmax) <4 m/s and stroke volume indexed to body surface area (SVi) ≤ 35 mL/m2 and LVEF ≥50% then if CT-derived aortic valve calcium score >2000 Agatston units in men, >1200 in women
OR
if mean gradient <40 mmHg and Vmax <4 m/s and SVi ≤ 35 mL/m2 and LVEF <50% then if CT-derived aortic valve calcification >2000 Agatston units in men, >1200 in women OR if low-dose dobutamine stress echocardiography with flow reserve (>20% increase in stroke volume) and AVA ≤1cm2
- Coronary calcium score ≥ 400 Agatston units (derived from routine pre-TAVI CT) or known coronary artery disease
- Selected for treatment with transfemoral TAVI.
- Written informed consent.
Exclusion criteria
- Concomitant valvular heart disease or ascending aortic aneurysm with indication for surgery or intervention
- Unprotected left main coronary stenosis >50% or left main not evaluable based on coronary computed tomography angiography derived from routine pre-TAVI CT
- Left ventricular ejection fraction (LVEF) < 30%
- New regional wall motion abnormalities on echocardiography
- Myocardial infarction in previous 12 months
- Coronary angiography in previous 12 months
- Prior left main stenting
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Diagnostic
Study locations
Switzerland · 1 center
- University Hospital Bern, Department of Cardiology — Bern
Identifiers
NCT: NCT06559332 · CAT Trial