Functional Assessment In TAVI: FAITAVI
Functional Assessment In TAVI: FAITAVI
The aim of this study is to compare the clinical outcome of patients with severe aortic valve
 stenosis and associated significant coronary artery disease treated with TAVI and a
 percutaneous myocardial revascularization dictated according to two different strategies:

 1. the Angiographically-guided strategy;

 2. the Physiologically-guided strategy.
Nowadays there are no clear recommendations about treatment of coronary in patients with
 severe aortic valve stenosis eligible for percutaneous valve replacement, and those available
 rely on a "common sense", class C, level of evidence. No randomized trials debride the skein
 about the best strategy of revascularization in this complex group of patients. In
 particular, it remains unclear whether it is preferable a preventive treatment or an
 ischemia-driven revascularization and, in addition, if it is safer and better for patient's
 health a simultaneous or a staged strategy.

 The aim of this study is to compare the clinical outcome of patients with severe aortic valve
 stenosis and associated significant coronary artery disease treated with TAVI and a
 percutaneous myocardial revascularization dictated according to two different strategies.

 The Angiographically-guided strategy is that of aiming the most complete degree of
 revascularization based on angiographic evaluation (stenting all coronary stenosis of major
 branches >2.5mm, with a %DS>50% as evaluated by visual estimation).

 The Physiologically-guided strategy is that of treating only lesions with FFR ≤0.80, and
 leaving on optimal medical treatment lesions with FFR >0.80. The iFR values will be recorded
 in all patients, and verified in the core laboratory to allow a post-hoc analysis correlating
 the 0.80 FFR cut-off with different iFR cut-off values, according to recent observations and
 using the same study end-points.

 Particular attention will be dedicated to the eventual occurrence of clinical events in
 patients deferred on the bases of FFR values >0.80 that show a discrepancy with positive
 (<0.89) iFR values to investigate the reliability of the FFR in the Aortic Stenosis setting.

 Both groups will receive the same TAVI strategy and optimal medical therapy. The study is
 designed as randomized, prospective, multi.center, open label, experimental trial with
 medical device. After discharge patients will be contacted at 30 days, 6 - 12 and 24 months
 after the procedure to assess the general clinical status and at 12 months to assess the
 occurrence of events included in the primary and secondary endpoints. The duration of study
 participation is 24 months for enrolment, ad 24 months for final follow-up.
Inclusion Criteria:

 1. Age > 18 years

 2. Written informed consent

 3. Diagnosis of severe native aortic valve disease with the indication to endovascular
 valve replacement given by Heart Team

 4. Diagnosis of at least one coronary stenosis >50% at angiography

 5. No specific pharmacologic treatment is required to enter the study

 Exclusion Criteria:

 1. Age < 18 years

 2. Pregnancy

 3. Lack of informed consent

 4. Impaired left ventricular function

 5. Signs or symptoms of acute (unstable) myocardial ischemia

 6. Contraindication to adenosine administration (e.g., asthma, chronic obstructive
 pulmonary disease, heart rate <50 beats/min, and systolic blood pressure <90 mmHg)

 7. Reduced survival expectancy due to severe co-morbidities (<1 year)

 8. Impossibility to obtain follow-up information

 9. The lack of any of inclusion criteria