Optimal Timing of Transcatheter Aortic Valve Implantation and Percutaneous Coronary Intervention - The TAVI PCI Trial

Prior treatment

• Admission with acute myocardial infarction within 30 days before randomization
• Elective coronary revascularization within 3 months before randomization
• Previous coronary artery bypass grafting (CABG)
• Any contraindications for dual antiplatelet therapy with aspirin and a P2Y12 inhibitor (clopidogrel, ticagrelor or prasugrel), except for patients on oral anticoagulation
• Participation in another clinical study with an investigational product
• Patient with previously treated aortic stenosis

Other illness

• Planned open heart surgery
• Life expectancy \<1 year due to other severe non-cardiac disease
• Acute COVID-19 infection

Other

• TAVI by transapical, subclavian, or transaortic access
• Syntax Score I ≥33
• Known pregnancy at the time of inclusion

• Patients ≥18 years with severe aortic stenosis and concomitant coronary artery disease accepted for transfemoral TAVI with an Edwards SAPIEN Transcatheter Heart Valve™ and PCI by a 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 the following criteria:
  • Dyspnea
  • Angina symptoms
  • Syncope
  • 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.
• At least one coronary artery lesion with ≥70% 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. Hemodynamic lesion assessment by fractional flow reserve (FFR), instantaneous wave-free ratio (iwFR), or comparable indices as well as intravascular imaging-guided PCI are left at the discretion of the operator.
• Written informed consent.