Randomized Trial of Coronary Artery Disease Assessment Strategies in Patients With Severe Aortic Stenosis Undergoing Transcatheter Aortic Valve Implantation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Transcatheter Aortic Valve Replacement
- Sponsor
- Insel Gruppe AG, University Hospital Bern
- Enrollment
- 546
- Locations
- 1
- Primary Endpoint
- Composite of all-cause death, myocardial infarction, any stroke, and heart failure hospitalization
- Status
- Recruiting
- Last Updated
- last year
Overview
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).
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Composite of all-cause death, myocardial infarction, any stroke, and heart failure hospitalization
Time Frame: 3 years
Primary endpoint. Valve Academic Research Consortium (VARC)-3 definitions)
Secondary Outcomes
- Patient reported health status(3 months, 1, 3 and 5 years)
- Rate of all cause death(3 months, 1, 3 and 5 years)
- Rate of cardiovascular death(3 months, 1, 3 and 5 years)
- Rate of disabling strokes(3 months, 1, 3 and 5 years)
- Rate of myocardial infarction(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(3 months, 1, 3 and 5 years)
- Rate of acute kidney injury(3 months, 1, 3 and 5 years)
- Rate of tachyarrhythmia(3 months, 1, 3 and 5 years)
- Rate of major vascular complications(3months, 1, 3 and 5 years)
- Rate of major cardiac structural complications(3 months, 1, 3 and 5 years)
- Rate of permanent pacemaker implantation(3 months, 1, 3 and 5 years)