Coronary Artery Disease Assessment Strategies in TAVI Patients (CAT)

Insel Gruppe AG, University Hospital Bern

Status: Enrolling

Conditions: Coronary Artery Disease; Transcatheter Aortic Valve Replacement; Heart Disease Risk Factors

Treatments: Diagnostic Test: Risk-based CAD management; Diagnostic Test: Invasive coronary angiography

Study type: Interventional

Funder types: Other

Identifiers

NCT06559332

CAT Trial

Details and patient eligibility

About

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).

Enrollment: 546 estimated patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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546 participants in 2 patient groups

Risk-based management strategy without invasive coronary angiography

Experimental group

Description:

Patients will not undergo routine coronary angiography prior to TAVI. Statin treatment of at least moderate intensity is recommended.

Treatment:

Diagnostic Test: Risk-based CAD management

Routine invasive coronary angiography

Other group

Description:

Routine invasive coronary angiography prior to TAVI. Percutaneous coronary intervention (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.

Treatment:

Diagnostic Test: Invasive coronary angiography