Functional Assessment In TAVI: FAITAVI (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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease; Aortic Valve Stenosis
• Intervention / Treatment: Device: Physiologically-guided strategy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 320
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Flavio L Ribichini, MD; Phone Number: 2320 +39 045 812; Email: flavio.ribichini@univr.it

Study Locations

• Italy
  • Verona, Italy, 37126
    • Recruiting
    • Azienda Ospedaliera Universitaria Integrata Verona
    • Contact: Flavio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Physiologically-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.	Device: Physiologically-guided strategy; 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 % coronary stenosis>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, 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; Other Names: Angiographically-guided strategy
Other: Angiographically-guided strategy; 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.	Device: Physiologically-guided strategy; 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 % coronary stenosis>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, 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; Other Names: Angiographically-guided strategy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of the treatment	Composite of all-cause death, myocardial infarction, stroke, major bleeding, need for target vessel revascularization as adjudicated by the Clinical Event Committee	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety endpoint	Composite of all cause mortality, all strokes (disabling and not disabling), life threatening bleeding, AKI (stages 2 or 3, including need for dialysis), coronary artery obstruction requiring intervention, major vascular complication, valve related dysfunction requiring repeat procedure	30 days

Collaborators and Investigators

• Sponsor: Universita di Verona

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2017
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: November 28, 2017
• First Submitted That Met QC Criteria: November 28, 2017
• First Posted (Actual): December 4, 2017

Study Record Updates

• Last Update Posted (Actual): May 8, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Coronary Disease; Coronary Artery Disease; Aortic Valve Stenosis
• Other Study ID Numbers: FAITAVI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No