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. 2024 Apr 15;20(8):e504-e510.
doi: 10.4244/EIJ-D-23-00679.

A randomised multicentre study of angiography- versus physiologyguided percutaneous coronary intervention in patients with coronary artery disease undergoing TAVI: design and rationale of the FAITAVI trial

Flavio Ribichini  1 , Gabriele Pesarini  1 , Tommaso Fabris  2 , Mattia Lunardi  1 , Marco Barbierato  3 , Gianpiero D'Amico  3 , Chiara Zanchettin  2   3 , Dario Gregori  2 , Tommaso Piva  4 , Elisa Nicolini  4 , Caterina Gandolfo  5 , Massimo Fineschi  6 , Anna Sonia Petronio  7 , Sergio Berti  8 , Francesco Caprioglio  9 , Francesco Saia  10 , Rocco Sclafani  11 , Giovanni Esposito  12 , Fabrizio D'Ascenzo  13 , Giuseppe Tarantini  2
Affiliations

A randomised multicentre study of angiography- versus physiologyguided percutaneous coronary intervention in patients with coronary artery disease undergoing TAVI: design and rationale of the FAITAVI trial

Flavio Ribichini et al. EuroIntervention. .

Abstract

The treatment of coronary artery disease (CAD) in patients with severe aortic valve stenosis (AVS) eligible for transcatheter aortic valve implantation (TAVI) is not supported by clinical evidence, and the role of physiology over anatomy as well as the timing of coronary intervention are not defined. FAITAVI (ClinicalTrials.gov: NCT03360591) is a nationwide prospective, open-label, multicentre, randomised controlled study comparing the angiography-guided versus the physiology-guided coronary revascularisation strategy in patients with combined significant CAD and severe AVS undergoing TAVI. Significant CAD will be defined as coronary stenosis ≥50%, as assessed by visual estimation in vessels ≥2.5 mm. Physiology will be tested by fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR). The study will be conducted at 15 sites in Italy. In the angiography arm, percutaneous coronary intervention (PCI) will be performed either before TAVI, during the TAVI procedure - before or after the valve implantation - or within 1 month±5 days of the valve implantation, left to the operator's decision. In the physiology arm, FFR and iFR will be performed before TAVI, and PCI will be indicated for FFR ≤0.80, otherwise the intervention will be deferred. In case of borderline values (0.81-0.85), FFR and iFR will be repeated after TAVI, with PCI performed when needed. With a sample size of 320 patients, the study is powered to evaluate the primary endpoint (a composite of death, myocardial infarction, stroke, major bleeding, or ischaemia-driven target vessel revascularisation). TAVI indication, strategy and medical treatment will be the same in both groups. After discharge, patients will be contacted at 1, 6, 12 and 24 months after the procedure to assess their general clinical status, and at 12 months for the occurrence of events included in the primary and secondary endpoints. FAITAVI is the first randomised clinical trial to investigate "optimal" percutaneous coronary intervention associated with TAVI in patients with severe AVS and CAD.

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Conflict of interest statement

F. Ribichini has received honoraria from and is proctor for Edwards Lifesciences and Medtronic. G. Tarantini has received lecture fees from Medtronic, Edwards Lifesciences, Abbott, and Boston Scientific. The other authors have no conflicts of interest to declare.

Figures

Figure 1
Figure 1. FAITAVI trial design.
DS: diameter stenosis; EP: endpoint; FFR: fractional flow reserve; iFR: instantaneous wave-free ratio; LVEF: left ventricular ejection fraction; PCI: percutaneous coronary intervention; PEP: primary endpoint; SEP: secondary endpoint; TAVI: transcatheter aortic valve implantation; TTE: transthoracic echocardiography
See this image and copyright information in PMC

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