Randomized Trial of Coronary Artery Disease Assessment Strategies in Patients With Severe Aortic Stenosis Undergoing Transcatheter Aortic Valve Implantation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 546
- 试验地点
- 2
- 主要终点
- Composite of all-cause death, myocardial infarction, any stroke, and heart failure hospitalization
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
盲法说明
Clinical event adjudication committee will be blinded to group allocation.
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe aortic stenosis defined by aortic valve area (AVA) ≤1cm2 AND mean gradient ≥40 mmHg or peak velocity ≥4.0 m/s
- •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
- •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.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Risk-based CAD management (Diagnostic Test)
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.
干预措施: Invasive coronary angiography (Diagnostic Test)
结局指标
主要结局
Composite of all-cause death, myocardial infarction, any stroke, and heart failure hospitalization
时间窗: 3 years
Primary endpoint. Valve Academic Research Consortium (VARC)-3 definitions)
次要结局
- 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)
- Patient reported health status(3 months, 1, 3 and 5 years)