Coronary Artery Disease Assessment Strategies in TAVI Patients

Insel Gruppe AG, University Hospital Bern546 enrolled

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

546

Conditions

Transcatheter Aortic Valve Replacement Coronary Artery Disease Heart Disease Risk Factors

Eligibility

Sex: ALLMin age: 70 Years

Medical Language ↔ 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 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

Outcomes

Primary Outcomes

Composite of all-cause death, myocardial infarction, any stroke, and heart failure hospitalization

Primary endpoint. Valve Academic Research Consortium (VARC)-3 definitions)

Time frame: 3 years