Coronary Artery Disease Assessment Strategies in TAVI Patients

Launched by INSEL GRUPPE AG, UNIVERSITY HOSPITAL BERN · Aug 14, 2024

Keywords

ClinConnect Summary

The CAT Trial is studying the best way to assess coronary artery disease (CAD) in patients who have severe aortic stenosis and are planning to undergo a procedure called transcatheter aortic valve implantation (TAVI). Typically, doctors perform a test called coronary angiography, which is an invasive procedure to look at the heart's blood vessels. However, this trial is comparing that standard approach with a non-invasive method to see which one leads to better outcomes for patients over three years. The goal is to find out if there is a more effective and safer way to evaluate heart health before TAVI.

To participate in the trial, patients must have severe aortic stenosis, which means their heart's aortic valve is narrowed and not working well. They also need to have a certain level of coronary artery disease, indicated by specific tests. Eligible participants will receive thorough information about the trial and provide their written consent before joining. Throughout the study, participants can expect regular check-ins and assessments to monitor their heart health and any changes in their condition. This trial is important because it aims to improve how doctors evaluate and treat patients with serious heart conditions, ultimately enhancing patient care.

Gender

ALL

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