Percutaneous Coronary Intervention before TAVI trial

The use of transcatheter aortic valve implantation (TAVI) for the treatment of symptomatic severe aortic valve stenosis (AoS) has grown exponentially during the past decade because of the increasing prevalence of AoS in the elderly and improved technique of the procedure. Coexisting coronary artery disease (CAD) is highly prevalent in patients with severe AoS undergoing TAVI; it is reported to be present in 40 to even 75 percent of the patients. Several registries did not find a correlation between severity of CAD and revascularization in clinical outcomes after TAVI. Even more, a recent meta-analysis showed that percutaneous coronary intervention (PCI) before TAVI in patients with a severe AoS and concomitant CAD did not lead to an additional clinical advantage. However, the available literature is predominantly based on single-center non randomized studies of relatively small sample size, and represents the early experience with TAVI. These data are based on treatment bias and therefore, current practice is still to perform PCI of major coronary arteries. Also, because access to the coronaries after TAVI is more technically challenging. Aim of the proposed project will be to evaluate the safety and cost-effectiveness of performing TAVI without revascularization of epicardial coronary arteries before the valve replacement.

Non-inferiority of omission of PCI prior aortic valve replacement by TAVI

4 and 12 months. Total follow up of 5 years (every year after one year of follow up)

TAVI only