The TransCatheter Valve and Vessels Trial

Prior treatment

• Concomitant presence of other than aortic valve disease requiring intervention
• Previous CABG, SAVR, TAVI or thoracotomy for any other reason
• Contraindication for dual antiplatelet therapy or expected surgical intervention requiring interruption of Dual Antiplatelet Therapy (DAPT) in the first 6 months
• Previous disabling stroke, Transient Ischemic Attack (TIA) in the last 6 months, or known severe stenosis of carotid or vertebral arteries

Other illness

• Patients in cardiogenic shock or acute heart failure, requiring inotropic agents during procedure and/or i.v. diuretics \<48 hours before procedure
• Recent myocardial infarction (less than 2 weeks)
• Known malignancy

Lab values

• Left ventricular ejection fraction \<30%
• Reduced renal function (Glomerular Filtration Rate (GFR) \<29 ml/min/1.73m2; Kidney Disease Outcomes Quality Initiative (KDOQI) stage 4 and 5)

Other

• Bicuspid or unicuspid aortic valve
• Involvement of left main trifurcation (all three branches being larger than 2 mm)
• Expected total stent length more 60mm per vessel
• FFR measurement judged impossible
• Life expectancy \<1 year
• Participation in other investigational clinical trials

• Symptomatic patients aged ≥70 years with aortic stenosis fulfilling one of these criteria (Aortic Valve Area (AVA) ≤1 cm2; mean gradient ≥40 mmHg; Aortic jet velocity \>4 m/sec; or Velocity index ≤ 0.25) feasible for treatment by both trans femoral or subclavian approach TAVI as well as conventional SAVR and where the Heart Team decides that treatment is needed (final decision is left to the Heart Team)
• Presence of ≥2 de novo coronary lesions of ≥50% diameter stenosis on visual estimation located in any of main epicardial coronary arteries, or side branches of a lumen caliber of more than 2 mm or single Left Anterior Descending (LAD) lesion with more than 20 mm length or involving a bifurcation (complex), feasible for treatment with CABG as well as PCI (Heart Team decision)
• Patients willing and capable to provide written informed consent