Clinical trial NCT06559332: Coronary Artery Disease Assessment Strategies in TAVI Patients
Official title: Randomized Trial of Coronary Artery Disease Assessment Strategies in Patients With Severe Aortic Stenosis Undergoing Transcatheter Aortic Valve Implantation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Transcatheter Aortic Valve Replacement
Coronary Artery Disease
Heart Disease Risk Factors
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: Clinical Trials Unit Bern (CTU)
name: Schweizerische Herzstiftung
First posted: 2024-08-19
Enrollment: 546
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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).


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

Primary outcomes:
measure: Composite of all-cause death, myocardial infarction, any stroke, and heart failure hospitalization
timeFrame: 3 years
Secondary outcomes:
measure: Patient reported health status
timeFrame: 3 months, 1, 3 and 5 years
measure: Patient reported health status
timeFrame: 3 months, 1, 3 and 5 years
measure: Patient reported health status
timeFrame: 3 months, 1, 3 and 5 years
measure: Rate of all cause death
timeFrame: 3 months, 1, 3 and 5 years
measure: Rate of cardiovascular death
timeFrame: 3 months, 1, 3 and 5 years
measure: Rate of disabling strokes
timeFrame: 3 months, 1, 3 and 5 years
measure: Rate of myocardial infarction
timeFrame: 3 months, 1, 3 and 5 years
measure: Rate of unplanned, urgent revascularization
timeFrame: 3 months, 1, 3 and 5 years
measure: Rate of elective revascularization
timeFrame: 3 months, 1, 3 and 5 years
measure: Rate of cardiovascular hospitalization
timeFrame: 3 months, 1, 3 and 5 years
measure: Rate of heart failure hospitalization
timeFrame: 3 months, 1, 3 and 5 years
measure: Rate of bleeding
timeFrame: 3 months, 1, 3 and 5 years
measure: Rate of acute kidney injury
timeFrame: 3 months, 1, 3 and 5 years
measure: Rate of tachyarrhythmia
timeFrame: 3 months, 1, 3 and 5 years
measure: Rate of major vascular complications
timeFrame: 3months, 1, 3 and 5 years
measure: Rate of major cardiac structural complications
timeFrame: 3 months, 1, 3 and 5 years
measure: Rate of permanent pacemaker implantation
timeFrame: 3 months, 1, 3 and 5 years
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: University Hospital Bern, Department of Cardiology
Study officials:
affiliation: University of Bern
name: Jonas Lanz, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: