PeRcutaneous cOronary intervention before Transcatheter Aortic Valve Implantation trial

Coexisting coronary artery disease (CAD) is highly prevalent in patients
undergoing transcatheter aortic valve implantation (TAVI) because of a severe
aortic valve stenosis (AoS). Several studies did not find a correlation between
severity of CAD and revascularization with post-TAVI clinical outcome. 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 studies of relatively small sample size,
and represents the early experience with TAVI. More importantly, most
cardiologists believe that these data are based on treatment bias and
therefore, current practice is still to perform PCI of major coronary arteries.
We hypothesize that performing a TAVI without PCI of the coexisting CAD before
TAVI is not inferior to performing TAVI with preceding PCI.

Aim of the proposed project will be to evaluate in a large and prospective
randomized way the safety and cost-effectiveness of performing TAVI without
full revascularization of major coronary arteries before the valve replacement.

The proposed trial is an investigator-initiated, multicenter, randomized,
open-label, non-inferiority trial.

The TAVI procedure will be performed according to standard clinical practice.
Implantation technique, choice of the valve type and size are at the operator's
discretion depending on clinical and anatomical considerations. All patients
will undergo diagnostic coronary angiography before TAVI to screen for the
presence of significant coronary artery disease as a standard of care. Patients
will be randomized to undergo TAVI with (usual care) or without (intervention
group) preceding standard PCI of the present coronary artery disease.

The work-up and TAVI procedure itself will be performed according to standard
clinical practice. Patients will have a work-up as a standard of care including
coronary angiography in the referral hospital, echocardiogram and computed
tomography (CT) scan. Omitting PCI in the intervention group would prevent
patients from undergoing unnecessary extra procedure(s). Thereby, potential
periprocedural and late complications in this fragile patient population of the
PCI procedure (e.g., vascular perforation, early or late stent restenosis or
thrombosis) are prevented. Additionally, PCI necessitates the use of dual
antiplatelet therapy and therefore increases the risk for (periprocedural)
bleeding during TAVI. However, theoretically, periprocedural complications of
the TAVI procedure (e.g., ischemia due to rapid pacing and balloon inflation)
could increase if optimal revascularization before the TAVI procedure is
omitted. Furthermore, access to the coronary arteries is more challenging after
TAVI. Therefore, the incidence of so-called hard endpoints (mortality,
myocardial infarction, stroke, major bleeding) or secondary endpoints like
persistence of anginal complaints or the need for interventions during the
first year after randomization will be closely monitored.