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 RibichiniGabriele PesariniTommaso FabrisMattia LunardiMarco BarbieratoGianpiero D'AmicoChiara ZanchettinDario GregoriTommaso PivaElisa NicoliniCaterina GandolfoMassimo FineschiAnna Sonia PetronioSergio BertiFrancesco CaprioglioFrancesco SaiaRocco SclafaniGiovanni EspositoFabrizio D'AscenzoGiuseppe TarantiniPublished in: EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology (2024)
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.
Keyphrases
- coronary artery disease
- transcatheter aortic valve implantation
- aortic valve
- aortic stenosis
- percutaneous coronary intervention
- clinical trial
- ejection fraction
- aortic valve replacement
- open label
- transcatheter aortic valve replacement
- coronary artery bypass grafting
- st segment elevation myocardial infarction
- study protocol
- acute myocardial infarction
- st elevation myocardial infarction
- antiplatelet therapy
- cardiovascular events
- randomized controlled trial
- acute coronary syndrome
- optical coherence tomography
- phase ii
- phase iii
- double blind
- newly diagnosed
- end stage renal disease
- computed tomography
- risk assessment
- coronary artery
- phase ii study
- early onset
- patient reported outcomes
- left ventricular
- heart failure
- atrial fibrillation
- coronary artery bypass
- peritoneal dialysis
- radiation therapy
- cross sectional
- healthcare
- brain injury
- prognostic factors
- minimally invasive