Assessing coronary artery disease in patients undergoing TAVI

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

This study is testing whether a non-invasive way to check for heart artery problems is better than the usual invasive method for patients with severe aortic stenosis who are getting a new heart valve.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 546 (estimated)
• Ages: 70 Years and up
• Sex: All
• Sponsor: Insel Gruppe AG, University Hospital Bern (other)
• Locations: 1 site (Bern)
• Trial ID: NCT06559332 on ClinicalTrials.gov

What this trial studies

This trial compares a non-invasive risk management strategy to routine invasive coronary angiography for assessing coronary artery disease in patients with severe aortic stenosis who are selected for transcatheter aortic valve implantation (TAVI). The study aims to evaluate the impact of these assessment strategies on adverse clinical outcomes over three years, as well as patient-reported outcomes. By determining the most effective approach, the trial seeks to clarify the benefit-risk balance of routine invasive procedures in this patient population.

Who should consider this trial

Good fit: Ideal candidates include patients with severe symptomatic aortic stenosis who are selected for TAVI and have specific coronary artery disease risk factors.

Not a fit: Patients with concomitant valvular heart disease or those requiring surgery for ascending aortic aneurysm may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved assessment strategies for coronary artery disease in TAVI patients, potentially reducing unnecessary invasive procedures.

How similar studies have performed: Other studies have explored similar non-invasive assessment strategies, but the specific approach in this trial is novel and untested.

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

Where this trial is running

Bern

• University Hospital Bern, Department of Cardiology — Bern, Switzerland (RECRUITING)

Study contacts

• Principal investigator: Jonas Lanz, MD, MSc — University of Bern
• Study coordinator: Jonas Lanz, MD MSc

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