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| Name | Class |
|---|---|
| Clinical Trials Unit Bern (CTU) | UNKNOWN |
| Schweizerische Herzstiftung | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Risk-based management strategy without invasive coronary angiography | Experimental | Patients will not undergo routine coronary angiography prior to TAVI. Statin treatment of at least moderate intensity is recommended. |
|
| Routine invasive coronary angiography | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Risk-based CAD management | Diagnostic Test | Patients will not undergo routine coronary angiography prior to TAVI. Statin treatment of at least moderate intensity is recommended. |
|
| 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 |
| 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) |
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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
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jonas Lanz, MD MSc | Contact | +41 31 632 21 11 | jonas.lanz@insel.ch | |
| Thomas Pilgrim, MD MPH | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Jonas Lanz, MD, MSc | University of Bern | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Bern, Department of Cardiology | Recruiting | Bern | 3010 | Switzerland |
sharing via https://boris.unibe.ch platform
after study completion
Data will be made available upon reasonable request
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Clinical event adjudication committee will be blinded to group allocation.
| Invasive coronary angiography | Diagnostic Test | 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. |
|
| 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 |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |