The TAVI PCI (optimal timing of Transcatheter Aortic Valve Implantation and Percutaneous Coronary Intervention) Trial

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 100

Inclusion Criteria

• Patients >=18 years with severe aortic stenosis and concomitant coronary
artery disease accepted for transfemoral TAVI with an Edwards SAPIEN
Transcatheter Heart Valve* by transfemoral access and PCI by the
multidisciplinary Heart Team
• Severe aortic stenosis defined as aortic valve area (AVA) <=1.0 cm2 and/or
mean pressure gradient >=40 mmHg (echocardiography) and at least one of:
1) Dyspnea
2) Angina symptoms
3) Syncope
4) Decline in left ventricular ejection fraction <50%, symptoms or fall in
blood pressure on exercise testing, or presence of high-risk criteria (peak
transaortic velocity >5.5 m/s, severe valve calcification, peak transaortic
velocity progression >=0.3 m/s per year, or severe pulmonary hypertension with
systolic pulmonary artery pressure >60 mmHg) according to current guidelines(6)
• At least one coronary artery lesion with 40-90% diameter stenosis and iwFR
<=0.89 or with >90% diameter stenosis on coronary angiogram (by visual
estimation) in a coronary artery >=2.5 mm in diameter and Thrombolysis in
Myocardial Infarction (TIMI) flow grade III, deemed amenable to PCI within 45
days before or after TAVI
• Written informed consent

Exclusion Criteria

• TAVI by transapical, subclavian, or transaortic access
• Admission with acute myocardial infarction within 30 days before randomization
• Elective coronary revascularization within 3 months before randomization
• Previous coronary artery bypass grafting (CABG)
• Syntax Score I >=33
• Any contraindications for dual antiplatelet therapy with aspirin and a P2Y12
inhibitor (clopidogrel, ticagrelor or prasugrel), except for patients on oral
anticoagulation
• Planned open heart surgery
• Known pregnancy at the time of inclusion
• Life expectancy <1 year due to other severe non-cardiac disease
• Participation in another clinical study with an investigational product
• Acute COVID-19 infection
• Patient with previously treated aortic stenosis

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Major adverse cardiovascular events (MACE) at 1 year, defined as a composite<br /><br>of:<br /><br>• All-cause death<br /><br>• Non-fatal myocardial infarction (MI)<br /><br>• Ischemia-driven revascularization<br /><br>• Rehospitalization (valve- or procedure-related including heart failure)<br /><br>• Life-threatening/disabling or major bleeding (according to VARC-2 (5))</p><br>

Secondary Outcome Measures