RECRUITINGINTERVENTIONAL

Coronary Artery Disease Assessment Strategies in TAVI Patients

Randomized Trial of Coronary Artery Disease Assessment Strategies in Patients With Severe Aortic Stenosis Undergoing Transcatheter Aortic Valve Implantation

About This Trial

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).

Who May Be Eligible (Plain English)

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 willing to sign a consent form. Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

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.

Locations (1)

University Hospital Bern, Department of Cardiology

Bern, Switzerland