Transcatheter Aortic Valve Replacement, Coronary Artery Disease, Heart Disease Risk Factors
Conditions
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).
Interventions
DIAGNOSTIC_TESTRisk-based CAD management
Patients will not undergo routine coronary angiography prior to TAVI. Statin treatment of at least moderate intensity is recommended.
DIAGNOSTIC_TESTInvasive 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.
Sponsors
Clinical Trials Unit Bern (CTU)
Schweizerische Herzstiftung
Insel Gruppe AG, University Hospital Bern
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Masking description
Clinical event adjudication committee will be blinded to group allocation.
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Patient reported health status | 3 months, 1, 3 and 5 years | Seattle Angina Questionnaire-7 (score from 0 to 100, with higher values indicating better health) |
| 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) |
| Rate of heart failure hospitalization | 3 months, 1, 3 and 5 years | — |
Countries
Switzerland
Contacts
Primary ContactJonas Lanz, MD MSc
Backup ContactThomas Pilgrim, MD MPH
Outcome results
None listed