Coronary Artery Disease Assessment Strategies in TAVI Patients (CAT)

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

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 Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease; Transcatheter Aortic Valve Replacement; Heart Disease Risk Factors
• Intervention / Treatment: Diagnostic test: Invasive coronary angiography; Diagnostic test: Risk-based CAD management

• Study Type: Interventional
• Enrollment (Estimated): 546
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jonas Lanz, MD MSc; Phone Number: +41 31 632 21 11; Email: jonas.lanz@insel.ch
• Study Contact Backup: Name: Thomas Pilgrim, MD MPH

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Recruiting
    • University Hospital Bern, Department of Cardiology
    • Contact: Jonas Lanz, MD, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Routine 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.	Diagnostic test: Invasive coronary angiography; Routine invasive coronary angiography prior to TAVI. 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.
Experimental: Risk-based management strategy without invasive coronary angiography; Patients will not undergo routine coronary angiography prior to TAVI. Statin treatment of at least moderate intensity is recommended.	Diagnostic test: Risk-based CAD management; Patients will not undergo routine coronary angiography prior to TAVI. Statin treatment of at least moderate intensity is recommended.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient reported health status	Seattle Angina Questionnaire-7 (score from 0 to 100, with higher values indicating better health)	3 months, 1, 3 and 5 years
Patient reported health status	Kansas City Cardiomyopathy Questionnaire-12 (score from 0 to 100, with higher values indicating better health)	3 months, 1, 3 and 5 years
Patient reported health status	EuroQol 5D 5L (index scores range from -0.59 to 1, with higher values indicating better health)	3 months, 1, 3 and 5 years
Rate of all cause death		3 months, 1, 3 and 5 years
Rate of cardiovascular death	(VARC-3)	3 months, 1, 3 and 5 years
Rate of disabling strokes	(VARC-3)	3 months, 1, 3 and 5 years
Rate of myocardial infarction	(VARC-3)	3 months, 1, 3 and 5 years
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	(VARC-3)	3 months, 1, 3 and 5 years
Rate of acute kidney injury	(VARC-3)	3 months, 1, 3 and 5 years
Rate of tachyarrhythmia	(VARC-3)	3 months, 1, 3 and 5 years
Rate of major vascular complications	(VARC-3)	3months, 1, 3 and 5 years
Rate of major cardiac structural complications	(VARC-3)	3 months, 1, 3 and 5 years
Rate of permanent pacemaker implantation	(VARC-3)	3 months, 1, 3 and 5 years

Collaborators and Investigators

• Sponsor: Insel Gruppe AG, University Hospital Bern
• Collaborators: Schweizerische Herzstiftung; Clinical Trials Unit Bern (CTU)
• Investigators: Principal Investigator: Jonas Lanz, MD, MSc, University of Bern

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2025
• Primary Completion (Estimated): March 31, 2030
• Study Completion (Estimated): March 31, 2032

Study Registration Dates

• First Submitted: August 14, 2024
• First Submitted That Met QC Criteria: August 14, 2024
• First Posted (Actual): August 19, 2024

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease
• Other Study ID Numbers: CAT Trial

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: sharing via https://boris.unibe.ch platform
• IPD Sharing Time Frame: after study completion
• IPD Sharing Access Criteria: Data will be made available upon reasonable request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No