Functional Assessment In TAVI: FAITAVI (FAITAVI)
Coronary Artery Disease, Aortic Valve Stenosis
About this trial
This is an interventional treatment trial for Coronary Artery Disease
Eligibility Criteria
Inclusion Criteria:
- Age > 18 years
- Written informed consent
- Diagnosis of severe native aortic valve disease with the indication to endovascular valve replacement given by Heart Team
- Diagnosis of at least one coronary stenosis >50% at angiography
- No specific pharmacologic treatment is required to enter the study
Exclusion Criteria:
- Age < 18 years
- Pregnancy
- Lack of informed consent
- Impaired left ventricular function
- Signs or symptoms of acute (unstable) myocardial ischemia
- Contraindication to adenosine administration (e.g., asthma, chronic obstructive pulmonary disease, heart rate <50 beats/min, and systolic blood pressure <90 mmHg)
- Reduced survival expectancy due to severe co-morbidities (<1 year)
- Impossibility to obtain follow-up information
- The lack of any of inclusion criteria
Sites / Locations
- Azienda Ospedaliera Universitaria Integrata VeronaRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Other
Physiologically-guided strategy
Angiographically-guided strategy
Patients randomized in this group will undergo stenting of coronary lesions showing FFR values ≤0.80 only. Lesions showing positive FFR measurements (<0.80) must be treated with PCI, before or after TAVI. Lesions showing clearly negative values (FFR >0.80) will not be treated with PCI before TAVI, and repeated FFR and iFR measurements after TAVI are strongly recommended. Lesions showing "borderline" FFR measurements before TAVI (FFR 0.80-0.83), should be measured again (both FFR and iFR) after TAVI, and the decision of treating of deferring treatment in a given lesion will be based on the FFR value obtained after TAVI. In all cases iFR values will be recorded for a post hoc analysis and for validation of the study endpoints according to iFR values.
Patients allocated in this group will undergo stenting of all coronary stenosis ≥50% as assessed by visual estimation in vessels ≥2.5mm. PCI can be performed before in a previous procedure, or after TAVI, but always within one month, ± 5 days of the valve implantation.PCI in the group randomized to the angio-guided procedure can be performed therefore, either before or after valve implantation, in the same or in different procedures. Implantation of second-generation drug eluting stents (DES) in all interventions is advised, but not mandatory, and the brand of the stent is left to the operators and center's choice.