Coronary Artery Disease Assessment Strategies in TAVI Patients

Not Applicable

Recruiting

• Conditions: Transcatheter Aortic Valve Replacement; Heart Disease Risk Factors; Coronary Artery Disease
• Interventions: Diagnostic Test: Risk-based CAD management; Diagnostic Test: Invasive coronary angiography

• Registration Number: NCT06559332
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-14
• Study First Submitted QC: 2024-08-14
• Study First Posted: 2024-08-19
• Status Verified: 2025-03
• Study Start: 2025-03-11
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-21
• Primary Completion: 2030-03-31
• Study Completion: 2032-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 546

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Risk-based management strategy without invasive coronary angiography	Risk-based CAD management	Patients will not undergo routine coronary angiography prior to TAVI. For patients without known atherosclerotic cardiovascular disease, a calcium score will be derived from the available routine computed tomography (CT) and in case of a score \>100, statin treatment of at least moderate intensity is recommended.
Routine invasive coronary angiography	Invasive coronary angiography	Routine invasive coronary angiography prior to TAVI. Percutaneous coronary intervention (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.

Primary Outcome Measures

Name	Time	Method
Composite of all-cause death, myocardial infarction, any stroke, and heart failure hospitalization	3 years	Primary endpoint. Valve Academic Research Consortium (VARC)-3 definitions)

Secondary Outcome Measures

Name	Time	Method
Patient reported health status	3 months, 1, 3 and 5 years	EuroQol 5D 5L (index scores range from -0.59 to 1, with higher values indicating better health)
Rate of all cause death	3 months, 1, 3 and 5 years
Rate of cardiovascular death	3 months, 1, 3 and 5 years	(VARC-3)
Rate of disabling strokes	3 months, 1, 3 and 5 years	(VARC-3)
Rate of myocardial infarction	3 months, 1, 3 and 5 years	(VARC-3)
Rate of unplanned, urgent revascularization	3 months, 1, 3 and 5 years
Rate of elective revascularization	3 months, 1, 3 and 5 years
Rate of cardiovascular hospitalization	3 months, 1, 3 and 5 years
Rate of heart failure hospitalization	3 months, 1, 3 and 5 years
Rate of bleeding	3 months, 1, 3 and 5 years	(VARC-3)
Rate of acute kidney injury	3 months, 1, 3 and 5 years	(VARC-3)
Rate of tachyarrhythmia	3 months, 1, 3 and 5 years	(VARC-3)
Rate of major vascular complications	3months, 1, 3 and 5 years	(VARC-3)
Rate of major cardiac structural complications	3 months, 1, 3 and 5 years	(VARC-3)
Rate of permanent pacemaker implantation	3 months, 1, 3 and 5 years	(VARC-3)

Trial Locations

Locations (1)

University Hospital Bern, Department of Cardiology; 🇨🇭 Bern, Switzerland